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The time course of the analgesic effect of acupuncture in the treatment of lateral epicondylalgia : a… Jeon, Jaewon 2016

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The time course of the analgesic effect of acupuncture in the treatment of lateral epicondylalgia: a randomized controlled feasibility trial comparing standard acupuncture and electroacupuncture by  Jaewon Jeon  B.Sc., Simon Fraser University, 2010  A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF  MASTER OF SCIENCE in THE FACULTY OF GRADUATE AND POSTDOCTORAL STUDIES (Rehabilitation Sciences)  THE UNIVERSITY OF BRITISH COLUMBIA (Vancouver)   October 2016   © Jaewon Jeon, 2016 ii  Abstract  Background: Resistance exercise is effective in relieving pain and improving grip strength in patients with lateral epicondylalgia (LE). However, patients’ activity-related pain can hinder their active participation in an exercise program. Acupuncture, particularly electro-acupuncture (EA), may be an effective complementary modality for pain control in order to promote patients’ participation in an exercise program and further to enhance therapeutic effects. Objectives: 1) assess the feasibility of a study designed to compare the effect size of analgesia induced by EA vs. standard acupuncture (SA); 2) estimate the time course of the analgesic effect of EA and SA for patients with LE; and 3) investigate if the analgesic effect of either intervention is associated with a change in pain-free grip strength.  Methods: A double-blind, parallel-group randomized controlled feasibility trial was conducted at a research centre located in Vancouver, Canada. Twenty-one participants with unilateral LE lasting more than 6 weeks duration were enrolled in the study.  The participants were randomly allocated to receive a single treatment of either EA (10-30 Hz) or SA. The primary outcome measure was pain-free grip strength, and the secondary outcome measures included the severity of lateral elbow pain (numeric rating scale), and patients’ global rating of change. Outcomes were measured over a 72-hour period. Results: No significant differences in outcome measures were found between the two treatment groups at any time point. A pattern of gradual improvement of pain-free grip strength (approximately 12N /day) over the 72-hour monitoring period in both treatment groups was observed, and this improvement was statistically significant compared to baseline at the 72-hour time point (38 ± 13N). In contrast, there was a statistically significant reduction in patients’ perceived pain level immediately after either treatment, and this improvement was maintained throughout the 72-hour follow-up period (-0.99~-1.59 ± 0.35). After 24 hours, 5% of patients reported themselves as feeling ‘much better’, 55% ‘slightly better’, 15% ‘unchanged’, 10% ‘slightly worse’, 10% ‘moderately worse’ and 5% ‘much worse’.  iii  Conclusion: Acupuncture may complement the therapeutic effect of rehabilitation exercise program as it provides immediate pain relief for patients with chronic LE.  Trial registration: ISRCTN14667535  Funding: none iv  Preface  This study was conducted by me, Jaewon Jeon, under the supervision of Dr. Alexander Scott. The study protocol was designed and developed by Dr. Alexander Scott (principal investigator) and myself, Jaewon Jeon (co-investigator) with guidance from Dr. Liisa Holsti and Dr. Lesley Bainbridge. My roles in this study project included: 1) posting recruitment advertisements at different locations in Vancouver; 2) emailing consent forms to interested participants who met the eligibility criteria; 3) arranging participants’ visits; 4) going over the eligibility questionnaire with each participant and doing a physical inspection of the elbow for presence of LE; 5) providing treatments to participants; 6) uploading collected data to REDCAP database; and 7) providing study data to a statistician, Dr. Rick White, for analysis.  This study protocol was approved by the University of British Columbia Clinical Research Ethics Board (CREB) (H15-00439) and registered online in the ISRCTN registry (http://www.isrctn.com/ISRCTN14667535) prior to the start of the clinical trial.   v  Table of Contents  Abstract .......................................................................................................................................... ii	  Preface ........................................................................................................................................... iv	  Table of Contents .......................................................................................................................... v	  List of Tables ................................................................................................................................ ix	  List of Figures ................................................................................................................................ x	  List of Abbreviations ................................................................................................................... xi	  Acknowledgements ..................................................................................................................... xii	  Dedication ................................................................................................................................... xiii	  Chapter 1: Introduction ................................................................................................................... 1	  1.1	   Overview ........................................................................................................................ 1	  1.2	   Lateral epicondylalgia .................................................................................................... 2	  1.2.1	   Prevalence and risk factors ..................................................................................... 2	  1.2.2	   Natural history ........................................................................................................ 3	  1.2.3	   Pathophysiology ...................................................................................................... 3	  1.2.4	   Mechanisms of injury ............................................................................................. 3	  1.2.5	   Motor impairments .................................................................................................. 4	  1.2.6	   Changes in pain processing ..................................................................................... 4	  1.2.7	   Treatment options ................................................................................................... 5	  1.3	   Acupuncture and pain control ........................................................................................ 6	  1.4	   Electro-acupuncture (EA) and pain control ................................................................... 7	  1.5	   Previous acupuncture studies in the treatment of LE ..................................................... 8	  vi  1.6	   Objectives .................................................................................................................... 12	  1.7	   Hypothesis .................................................................................................................... 12	  1.8	   Significance of research ............................................................................................... 12	  Chapter 2: Study design ................................................................................................................ 13	  2.1	   Recruitment .................................................................................................................. 13	  2.2	   Participants ................................................................................................................... 13	  2.3	   Study setting ................................................................................................................. 14	  2.4	   Baseline measurements ................................................................................................ 14	  2.5	   Baseline information .................................................................................................... 14	  2.5.1	   Patient-rated tennis elbow evaluation (PRTEE) ................................................... 15	  2.5.2	   Tampa scale for kinesiophobia- 11 (TSK-11) ...................................................... 15	  2.6	   Interventions ................................................................................................................ 15	  2.6.1	   SA ......................................................................................................................... 15	  2.6.2	   EA ......................................................................................................................... 17	  2.7	   Randomization ............................................................................................................. 17	  2.7.1	   Changes to study design ........................................................................................ 18	  2.8	   Blinding ........................................................................................................................ 18	  2.8.1	   Participants ............................................................................................................ 18	  2.8.2	   Clinician ................................................................................................................ 19	  2.8.3	   Assessor ................................................................................................................ 19	  2.9	   Outcome measures ....................................................................................................... 20	  2.9.1	   Pain-free grip strength (PFGS) ............................................................................. 20	  2.9.2	   Perceived pain level .............................................................................................. 21	  vii  2.9.3	   Global rating of change (GROC) .......................................................................... 22	  2.9.4	   Survey ................................................................................................................... 23	  2.10	   Statistical analysis ...................................................................................................... 23	  Chapter 3: Results ......................................................................................................................... 24	  3.1	   Feasibility of procedures .............................................................................................. 24	  3.1.1	   Recruitment ........................................................................................................... 24	  3.1.2	   Recruitment rate .................................................................................................... 26	  3.1.3	   Retention rate ........................................................................................................ 26	  3.1.4	   Drop/withdrawal rate ............................................................................................ 26	  3.1.5	   Evaluation of eligibility criteria ............................................................................ 26	  3.1.6	   Randomization ...................................................................................................... 26	  3.1.7	   Baseline measures ................................................................................................. 26	  3.1.8	   Outcome measures ................................................................................................ 27	  3.1.8.1	   PFGS .............................................................................................................. 27	  3.1.8.2	   NRS ................................................................................................................ 28	  3.1.8.3	   GROC ............................................................................................................ 29	  3.1.8.4	   Survey ............................................................................................................ 29	  3.1.9	   Safety of procedure ............................................................................................... 29	  3.1.10	   Blinding methods ................................................................................................ 30	  3.1.10.1	   Participants ................................................................................................... 30	  3.1.10.2	   Assessor ....................................................................................................... 30	  3.2	   Baseline characteristics, outcomes and estimations ..................................................... 30	  3.2.1	   Baseline ................................................................................................................. 30	  viii  3.2.2	   Pain-free grip strength ........................................................................................... 32	  3.2.3	   Perceived pain level .............................................................................................. 33	  3.2.4	   Global rating of change ......................................................................................... 37	  3.2.5	   Sample size calculation for a larger study ............................................................ 38	  3.2.6	   Survey ................................................................................................................... 38	  Chapter 4: Discussion ................................................................................................................... 39	  4.1	   Feasibility of procedures and methods ........................................................................ 39	  4.2	   Outcomes ..................................................................................................................... 42	  4.3	   Strengths and limitations .............................................................................................. 46	  4.4	   Conclusion ................................................................................................................... 47	  Bibliography ................................................................................................................................ 49	  Appendices ................................................................................................................................... 61	  Appendix A Consent form ................................................................................................ 61	  Appendix B Eligibility criteria questionnaire ................................................................... 70	  Appendix C Baseline information sheet ........................................................................... 73	  Appendix D Patient-Rated Tennis Elbow Evaluation (PRTEE) ...................................... 74	  Appendix E Tampa Scale of Kinesiophobia – 11 (TSK-11) ............................................ 76	  Appendix F Pain diary ...................................................................................................... 77	  Appendix G Global rating of change ................................................................................ 83	  Appendix H Survey .......................................................................................................... 84	   ix  List of Tables  Table 3.1 Baseline demographic and clinical characteristics ....................................................... 31	  Table 3.2 Changes in PFGS following treatment ......................................................................... 32	  Table 3.3 Changes in the perceived pain level (NRS, measured onsite) over the 72 hour follow-up period ....................................................................................................................................... 34	  Table 3.4 Changes in the perceived pain level (NRS, measured using a pain diary) over the 72 hour follow-up period ................................................................................................................... 35	  Table 3.5 GROC at 24 hours follow up ........................................................................................ 38	   x  List of Figures  Figure 2.1 Locations of acupuncture points .................................................................................. 16	  Figure 2.2 Sham electro-acupuncture set up ................................................................................. 19	  Figure 2.3 Position for pain-free grip strength measurement ....................................................... 21	  Figure 3.1 Flow of participants ..................................................................................................... 25	  Figure 3.2 Changes in PFGS over time ........................................................................................ 33	  Figure 3.3 Changes in perceived pain level (onsite) over time ..................................................... 36	  Figure 3.4 Changes in perceived pain level (NRS, pain diary) over time .................................... 37	   xi  List of Abbreviations  CGRP: Calcitonin Gene-Related Peptide CNS: Central Nervous System EA: Electro-Acupuncture ECRB: Extensor Carpi Radialis Brevis  GROC: Global Rating of Change  LE: Lateral Epicondylalgia  NRS: Numeric Rating Scale NSAIDS: Non-Steroidal Anti-Inflammatory Drugs PFGS: Pain-Free Grip Strength PRP: Platelet Rich Plasma PRTEE: Patient-Rated Tennis Elbow Evaluation SA: Standard Acupuncture SP: Substance P TSK: Tampa Scale of Kinesiophobia  xii  Acknowledgements  First and foremost, I would like to express my sincere gratitude to my supervisor, Dr. Alexander Scott, for his continuous encouragement, support and guidance throughout my study at the UBC. I really enjoyed being a tendinophile for the last two years- and without Dr. Scott, this couldn’t have been possible. I also would like to thank my supervisory committee, Dr. Liisa Holsti and Dr. Lesley Bainbridge, for their valuable input in my study. Dr. Holsti’s clear direction was of great assistance in my choosing the outcome measure and revising my thesis, and Dr. Bainbridge’s guidance led me to view my project from a different perspective. Additionally, I would like to appreciate Dr. Rick White for analyzing my study data and providing an explanation of my study results.  Further, I would like to acknowledge the contribution of the Centre for Hip Health and Mobility (CHHM) for providing a place and support for my clinical trial. In addition, I couldn’t have completed my study without help & support from CHHM staff and trainee. Thanks to Erin Bussin for all the measurements she took from the participants; Lutetia Wallis-mayer for helping with recruitment and screening participants; Danmei Liu & Victor Espinosa for setting up the REDCAP database for my study; Paul Drexler, Danmei Liu, Thuraya Altkebi, Charlie Waugh, Vivian Chung, Agnetha de Sa, Ryan Falck, & Lynita White for being a witness for the placement of needles & the randomization process; and Takao Ito for providing a timer for my study!   Last but not least, I would like to thank my parents & my brother J.J for supporting me to pursue my dreams and goals.   xiii  Dedication   To Cathy’s Clown      “The sunshine came to shine on my life” 1  Chapter 1: Introduction  1.1 Overview Resistance exercise program is effective in relieving pain and improving grip strength in patients with lateral epicondylalgia (LE) (Cullinane, Boocock, & Trevelyan, 2014; Ortega-Castillo & Medina-Porqueres, 2015; Raman, MacDermid, & Grewal, 2012). However, patients’ activity-related pain can hinder their active participation in an exercise program (Al-Obaidi, Nelson, Al-Awadhi, & Al-Shuwaie, 2000; Damsgard, Thrane, Anke, Fors, & Røe, 2010; Vlaeyen & Linton, 2000). Thus, exercise programs are often combined with other therapeutic modalities for the conservative treatment of LE (Cullinane et al., 2014).  Acupuncture is one of the modalities available for treatment of LE. Acupuncture stimulates afferent nerve pathways, which culminate in the release of opioid substances (Andersson & Lundeberg, 1995; Han, 2004), producing pain relief. Particularly, electro-acupuncture (EA) may provide a greater analgesic effect compared to standard acupuncture (SA) (Ulett, Han, & Han, 1998). Studies have found that, compared to SA, EA can modulate the release of different types of opioids in the body by manipulating the frequency with which sensory nerves are stimulated (Han, 2003, 2004). In addition, animal studies have demonstrated that EA may enhance the recovery from tendon injury by stimulating tendon healing (de Almeida et al., 2012; Fujita, Hukuda, & Doida, 1992; Neal & Longbottom, 2012; Wojtys, Carpenter, & Ott, 1993). Therefore, acupuncture, particularly EA, may be a good modality to combine with exercise in order to promote patients’ participation in rehabilitation program and further to enhance pain relief and tendon healing effects for patients with LE.  In order to combine these two treatment modalities together in rehabilitation program for LE, information about the temporal pattern of acupuncture analgesia occurring after one acupuncture treatment is needed. However, no study has investigated the magnitude or time course of pain relief 2  provided by EA for treatment of LE. Therefore, this study focused on observing the temporal pattern of acupuncture analgesia shown in patients with LE and explored how patients with LE perceive pain differently over time after EA in order to determine the best time to incorporate EA in rehabilitation program.  1.2 Lateral epicondylalgia Lateral epicondylalgia (LE) or tennis elbow is a condition characterized by lateral elbow pain which is aggravated by the use of the wrist extensors, such as gripping, lifting, and typing (Geoffroy, Yaffe, & Rohan, 1994). With LE, changes occurring in the affected tendon tissues lead to pain, weak muscle strength and impaired motor function of the arm (Coombes, Bisset, & Vicenzino, 2009). This condition can lead to limited performance at work and difficulties in performing simple daily tasks, such as holding a cup or carrying a bag (Geoffroy et al., 1994). 1.2.1 Prevalence and risk factors  LE is a common disorder which affects about 1-3% of general population with a peak prevalence between the ages of 30 and 50 (Bisset et al., 2011; Hamilton, 1986; Leclerc, Landre, Chastang, Niedhammer, & Roquelaure, 2001; Shiri, Viikari-Juntura, Varonen, & Heliovaara, 2006). Particularly, the prevalence goes up to 20% in industry, such as assembly, meat or fishery, where workers are exposed to strenuous and repetitive work (Fan et al., 2014; Leclerc et al., 2001); and it further goes up to 40- 50% in a population of tennis players (Geoffroy et al., 1994; Gruchow & Pelletier, 1979). Indeed, previous studies have identified that frequent force exertion, repetitive activities of the upper limb, heavy lifting and such activities with poor forearm posture, for instance, repetitive, forceful lifting while keeping the forearm pronated, are all predisposing factors for LE. (Fan et al., 2014; Leclerc et al., 2001; Ono et al., 1998).  3  1.2.2 Natural history Patients with LE have episodes of symptoms with an average duration of 6 to 24 months (Coombes, Bisset, Brooks, Khan, & Vicenzino, 2013). In general, the majority of patients with chronic LE show improvement within one year, with or without intervention (Coombes et al., 2013; Smidt et al., 2006). However, a small percentage of patients who fail to respond to conservative treatments undergo surgery (Coombes et al., 2009; St. Pierre & Nirschl, 2006). Poor prognosis is likely to be seen in patients with a longer duration of LE, concomitant neck pain or severe pain at baseline (Smidt et al., 2006); and in patients who are employed in manual jobs that require physically demanding work (Haahr & Andersen, 2003).  1.2.3 Pathophysiology Traditionally, LE was considered an inflammatory condition; hence, it was named lateral epicondylitis. However, studies have commented on the absence of inflammatory cells, such as macrophages, lymphocytes or neutrophils in the LE region (Alfredson, Ljung, Thorsen, & Lorentzon, 2000; Kraushaar & Nirschl, 1999; Regan, Wold, Coonrad, & Morrey, 1992). Instead, the local elevation of neuropeptides (Substance P [SP], Calcitonin Gene-related Peptide [CGRP] and Glutamate) associated with peripheral nociception has been observed (Alfredson et al., 2000; Ljung, Forsgren, & Friden, 1999; Ljung, Alfredson, & Forsgren, 2004; Peterson et al., 2013); the presence of such chemicals can also lead to mast cell activation, microvascular leakage, local edema and pain (Ljung et al., 2004). Currently, the general consensus is that chronic LE is a condition with degenerative changes occurring at the local tendon, such as presence of disorganized collagen fibers, increased fibroblasts and neovascularization (Coombes et al., 2009; Kraushaar & Nirschl, 1999).  1.2.4 Mechanisms of injury As other tendinopathic conditions, chronic overuse of the tendon is considered the main risk factor for LE.  Overloading of the tendon of wrist extensors through lifting and carrying heavy objects and chronic 4  exposure to increased contact pressure between the bone (the lateral edge of the capitulum of humerus) and the tendon of ECRB through repetitive elbow extension and forearm pronation could create abrasion to tendon tissues (Bunata, 2007; Tanaka et al., 2011). When microtrauma is accumulated in the local tendon tissues, it may overwhelm the ability of the body to repair the damaged tissue, leading to a tendinopathic condition of the elbow, LE (Kraushaar & Nirschl, 1999; Tosti, Jennings, & Sewards, 2013). Although, the primary site of injury is the origin of Extensor Carpi Radialis Brevis (ECRB), the tendon of Extensor Digitorum Communis is affected as well in approximately 30% of patients (Kraushaar & Nirschl, 1999).  1.2.5 Motor impairments Reduction in Pain-Free Grip Strength (PFGS) has been observed in patients with chronic LE. On average, PFGS of the affected arm has been shown to be 36-57% grip strength of unaffected/healthy arm (Abbott, Patla, & Jensen, 2001; Bisset, Russell, Bradley, Ha, & Vicenzino, 2006; Sran, Souvlis, Vicenzino, & Wright, 2002; Vicenzino, Paungmali, Buratowski, & Wright, 2001).  In addition to impaired grip strength, patients with LE also demonstrated delayed reaction times and slow movement speeds. (Bisset, Coppieters, & Vicenzino, 2009; Bisset et al., 2006; Chourasia et al., 2012; Heales, Lim, Hodges, & Vicenzino, 2013). These sensorimotor deficits are present not only in the affected arm with LE, but also in the unaffected arm compared to healthy controls, and such impairments may be related to changes occurring in the central nervous system after chronic exposure to painful stimuli  (Bisset et al., 2006; Heales et al., 2013).   1.2.6 Changes in pain processing With the chronic condition of LE, processing of pain involves both peripheral and central nervous systems. Peripherally, SP and CGRP innervations have shown to be present at the origin of the ECRB muscle; and the tightness of ECRB muscle observed in patients with chronic LE may be a contributing factor for increased release of SP and CGRP at the local tendon (Ljung et al., 2004). An enhanced level of 5  SP and CGRP causes neurogenic inflammation, which in turn increases pain perception and local edema (Coombes et al., 2009). Centrally, an altered functional state of the central nervous system (CNS) may be responsible for increased responsiveness to pain signals and secondary hyperalgesia observed in patients with chronic LE (Heales et al., 2013; Latremoliere & Woolf, 2009): studies on patients with chronic unilateral LE have demonstrated that the pressure pain threshold over the lateral epicondyle of their affected arm is approximately 50% of their unaffected arm (Coombes et al., 2009). In addition to mechanical hyperalgesia in the LE affected arm, patients with chronic unilateral LE have reduced pressure pain threshold in their unaffected arm compared to health controls; bilateral impairment of reaction time and speed of movement were also observed (Fernandez-Carnero et al., 2009; Heales et al., 2013; Pienimaki, Kauranen, & Vanharanta, 1997; Slater, Arendt-Nielsen, Wright, & Graven-Nielsen, 2003). Evidence of such changes occurring beyond the LE affected region support the involvement of the CNS in pain processing.  1.2.7 Treatment options  Currently, many modalities are available for the treatment of LE, however, no single treatment has shown sufficient evidence to support its effectiveness (Bisset, Coombes, & Vicenzino, 2011; Cullinane et al., 2014; Dingemanse, Randsdorp, Koes, & Huisstede, 2014; Olaussen, Holmedal, Lindbaek, Brage, & Solvang, 2013). The common conventional treatments for LE are corticosteroid injections and the use of NSAIDS: Olaussen et al (2013) found evidence that corticosteroid injections have a short term analgesic effect on LE, but an unfavourable effect (i.e. increased risk of recurrence) in the intermediate term. In addition, corticosteroid injections were often accompanied by adverse effects, such as post-injection pain and skin irritation (Bisset et al., 2011; Coombes, Bisset, & Vicenzino, 2010). Oral NSAIDS may be effective for short-term pain relief. However, the quality of evidence was very low. In addition, intake of oral NSAIDS has showed side effects, such as abdominal pain and diarrhea, in some people (Bisset et al., 6  2011; Pattanittum, Turner, Green, & Buchbinder, 2013). On the other hand, topical NSAIDS are effective for short-term pain relief. Yet, topical NSAIDS are also responsible for a significantly greater risk of adverse effects compared to placebo ( Bisset et al., 2011; Pattanittum, Turner, Green, & Buchbinder, 2013).   The common alternative therapies for LE include various modalities of physical therapy: Cullinane et al (2014) found evidence that the inclusion of eccentric exercise in multimodal therapy enhances the outcomes in patients with LE; however, there are very few studies which have investigated the effect of exercise alone compared to placebo; therefore, the effectiveness of exercise on its own in patients with LE is inconclusive (Bisset, Paungmali, Vicenzino, & Beller, 2005; Bisset et al., 2011; Cullinane et al., 2014). Low-level laser therapy has shown to provide short-term pain relief compared to sham treatment/or other non-laser treatment (Bisset et al., 2005; Bjordal et al., 2008). However, other electrophysical therapies, such as ultrasound, extracorporeal shock wave therapy (ESWT), and transcutaneous electrical nerve stimulation (TENS), have not generated sufficient evidence to support their effectiveness. (Dingemanse et al., 2014; Sims, Miller, Elfar, & Hammert, 2014).  1.3 Acupuncture and pain control  The mechanisms of acupuncture analgesia are commonly explained by the gate control theory, and by the release of endogenous opioids. Gate control theory explains that transmission of painful signals through large sensory fibers could be blocked or reduced by stimulating small sensory fibers, such as A-delta fibers, near the painful region (Melzack, 1996): small sensory fibers, A-delta fibers, can transmit somatosensory information more rapidly than larger sensory fibers, C-fibers. Thus, when A-delta fibers in the same segment as painful region are stimulated with a needle, impulses travel more quickly to the spinal cord and activate interneurons in the spinal cord, blocking the transmission of pain signals. Therefore, one feels less pain. However, this mechanism explains only short-term pain relief, mainly during stimulation (Carlsson, 2002).  7  The effect of acupuncture is also commonly explained by its action on the endogenous opioid system. The finding of blockage or reversal of acupuncture analgesia by Naloxone, supports the involvement of opioid substances in acupuncture analgesia (Cheng & Pomeranz, 1980; Mayer, Price, & Rafii, 1977; Sjolund & Eriksson, 1979). Various opioid substances, such as met-enkephalin, beta-endorphin, and dynorphin, are released within the CNS, at either spinal or supraspinal level (Bowsher, 1990; Zhao, 2008): stimulation of A-delta fibers with a needle induces a release of met-enkephalin at dorsal horn of the spinal cord. This release of opioid at spinal cord inhibits cells that relay painful signals from C-fibers to the brain. The mechanism of endorphin release following acupuncture is not clear, however, the supposition is that the release of beta-endorphin by acupuncture is involved with the hypothalamus and its beta-endorphin containing pathway connected to the periaqueductal gray matter (Sims, 1997). Therefore, pain relief lasts longer for a while even after the end of treatment (Carlsson, 2002).  1.4  Electro-acupuncture (EA) and pain control EA is a type of acupuncture in which electrical currents are applied to the body through a pair of acupuncture needles. EA has been shown to stimulate the release of different opioid substances at different frequency settings: at a low frequency setting (2-5 Hz), EA stimulates the release of met-enkephalin, beta- endorphin, and endomorphins; whereas, at a high frequency setting (20-200Hz), EA stimulates the production of dynorphins (Han, 2003, 2004; Ulett et al., 1998; Zhang, Lao, Ren, & Berman, 2014; Zhao, 2008); and with an alternating frequency setting, EA stimulates the release of all four types of opioid substances in the body (Han, 2003, 2004). In fact, it has been suggested that EA might produce greater analgesic effect than standard acupuncture (Ulett et al., 1998).  Compared to SA, EA may induce a greater activation of peripheral nerves and therefore more extensive activation of the endogenous opioid system (Zhang et al., 2014; Zhao, 2008).   8   1.5 Previous acupuncture studies in the treatment of LE   Four acupuncture RCTs (Fink, Wolkenstein, Luennemann, et al., 2002; Fink, Wolkenstein, Karst, & Gehrke, 2002; Irnich et al., 2003; Molsberger & Hille, 1994) have reported significantly greater short-term pain relief compared to sham acupuncture in patients with LE. However, the effects of acupuncture and sham acupuncture in comparison to ‘no treatment’ was not studied in all four studies: Fink, Wolkenstein, Karst, et al. (2002) investigated the effect of acupuncture (LI 10, LI 11, LU 5, LI 4, SJ 5, one tender point over muscular origin of the wrist extensors) compared to sham acupuncture (insertion of needles on non-acupuncture points) on pain intensity, muscle strength and functional recovery over a 2-month period in patients with chronic LE. This study found that acupuncture provided significantly greater pain relief to patients with chronic LE compared to sham acupuncture at the first follow-up (2 weeks after the end of therapy). However, no significant difference was found in the pain intensity level between the two groups at the second follow-up (2 months after the end of therapy). The results of this study might have been biased because subjects who dropped out (3 out of 45) during the treatment period were excluded from data analysis. Also, unlike their description of using a verbal rating scale for pain measurement, a visual analogue scale was used instead for the pain intensity level; and the description of how the pain intensity level was measured on a visual analogue scale was not reported.  The success of the sham acupuncture in blinding the subject and the assessor was also not reported; thus, a high risk of bias in this study was possible.  Fink, Wolkenstein, Luennemann, et al. (2002) extended Fink et al (1)’s study as they further investigated the effectiveness of acupuncture for pain relief in patients with chronic LE for 12 months. This study demonstrated that acupuncture provided better analgesic effect to patients with chronic LE compared to sham acupuncture; however, the difference between the two groups was significant only in the short-term (2 weeks). No significant difference was found at 2 and 12 month follow-up. The results of this study could have been biased because: 1) it did not describe any restrictions given to participants (e.g. 9  refrain from NSAIDS, analgesics, or other therapeutic intervention) after the treatment period: therefore, it is not known whether participants received any other therapeutic intervention after the treatment period (between follow-up) and whether the pain level was influenced by any confounding factors at the time of measurement; 2) most of patients with LE usually recover within a year (Coombes et al., 2009). Thus, this natural resolution must be considered a factor when measuring the effect of intervention on LE one year after the end of therapy. Without having an additional no-treatment control group, the long-term effect of intervention cannot be conclusive; 3) the methods of pain measurement were different for the final follow up compared to the previous ones: the participants were examined in the laboratory by the assessor at baseline, 2 week and 2 month follow-up. However, for the final follow up, participants filled out self-assessment questionnaires at home. The use of different methods for collecting pain intensity data might have influenced how participants reported their pain intensity level; and 4) only correctly filled-out questionnaires were included for the final follow up analysis (69% of participants).  Irnich et al (2003) also examined the effect of acupuncture vs. sham acupuncture (insertion of needles in non-acupuncture points) for the treatment of patients with chronic LE. Each patient received three treatments within ten days and was assessed immediately after the first treatment, immediately after the third treatment and 14 days after the third treatment. Both acupuncture and sham acupuncture groups showed improvement immediately after the first treatment; however, no difference was found between the two groups. Fourteen days after the third treatment, the acupuncture group showed significantly greater pain relief compared to the sham acupuncture group. However, this study had limitations in that: 1) patients were not appropriately randomized; 2) the study did not describe any instructions that were given to patients during the treatment and the follow-up periods. Therefore, it is not known whether the results were influenced by any confounding factors; and 3) although the results suggested that a statistically significant improvement after three treatments of acupuncture compared to sham acupuncture, it is not clear whether this difference between the two types of acupuncture was clinically significant or not.   Molsberger & Hille (1994) investigated the effect of a single treatment of acupuncture on the 10  magnitude and the duration of pain relief for patients with chronic LE. Patients received one treatment of either hetero-segmental acupuncture or sham acupuncture (no insertion of a needle).  Patients in the acupuncture group had an average of 55.8% pain reduction compared to 15% in patients in the sham acupuncture group; in addition, the acupuncture group had a longer duration of the analgesic effect compared to the sham-acupuncture group (20.2 hours vs. 1.4 hours). However, this study has limitations in that: 1) the study failed to describe how a randomization of participants’ group allocation was made. Therefore, it cannot be determined whether the randomization was done appropriately; and 2) there was no report of whether their blinding method was successful or not. Therefore, it is not clear whether the result was influenced by participants’ or clinician’s anticipation bias.  Davidson, Vandervoort, Lessard, & Miller (2001) investigated the effect of acupuncture vs. ultrasound on pain level, pain-free grip strength and disability in patients with LE. Participants received eight treatments of either acupuncture or ultrasound over a 3-4 weeks period. This study demonstrated that acupuncture was significantly more effective in reducing pain compared to an ultrasound group when pre- and post-intervention pain ratings were compared; however, there were no significant differences between the two groups in pain reduction, muscle strength, and functional recovery after 8 treatment sessions. This study had insufficient sample (16 participants) to detect the significant difference between the two groups, and therefore, the findings of this study are not conclusive.   The type of acupuncture may influence the effect of acupuncture in the treatment of LE: Yong, Zhonghua, Dongbin, & Rangke (1998) compared the effect of a single treatment of floating acupuncture vs. electro-acupuncture for patients with LE. 81.5% of subjects in the floating acupuncture group reported a complete recovery in comparison to 22.2% in electro-acupuncture group, suggesting the greater therapeutic effect of floating acupuncture over electro-acupuncture. However, the quality of evidence of this study is very low for the following reasons: 1) it failed to report the randomization method. Therefore, it cannot be determined whether their randomization method was appropriate, 2) there was no blinding of the clinician, the assessor or the participants. Therefore, the results might have been biased as 11  a result of absence of blinding, and 3) this study did not use a reliable and valid outcome measure. Instead, participants were asked to express their improvement in percentage of pain relief.  Tsui & Leung (2002) investigated the effect of electro-acupuncture vs. standard acupuncture in the treatment of LE. Participants received six treatments of either electro-acupuncture or standard acupuncture in a two week period. After two weeks, the electro-acupuncture group had significantly greater improvements in both pain level and PFGS compared to the standard acupuncture group. The quality of evidence of this study is also poor because of a lack of description of their randomization method and absence of blinding of the participants as well as the clinician.  The depth of needling may be a factor that influences the effect of acupuncture: Hacker & Lundeberg (1990) compared the effect of deep (needling on depths of 1.25-2.5cm at which patients felt feeling of tension, numbness, tingling or tenderness) vs. superficial needing (needling to subcutaneous level) for patients with LE. Participants received a total of ten treatments of either intervention and were assessed after 10 treatments, 3 months and 1 year after the treatment sessions. Participants in the deep needling group showed significantly greater improvements both in pain intensity and in PFGS compared to superficial needling after 10 treatments. However, no significant differences were found between the two groups at 3- and 12-month follow-up. Although this study suggests the importance of deep needling in acupuncture treatment, further studies may be needed to support these findings because this study also had limitations in that: 1) it did not describe the randomization method they used, and 2) it failed to report the success of the blinding of the participants as well as the assessor.  Previous systematic reviews on the effect of acupuncture in the treatment of LE have drawn contradictory conclusions. Green et al. (2002) concluded that there is insufficient evidence to support the effectiveness of acupuncture in the treatment of LE because of small number of trials for review and because of their methodological limitations. However, more studies were added in the latter two systematic reviews (Gadau et al., 2014; Trinh, Phillips, Ho, & Damsma, 2004) and this led to a different 12  conclusion from Green et al. (2002),  suggesting acupuncture is effective for the short-term relief of LE pain.   Although the findings of the previous studies support the use of acupuncture for the short-term analgesic effect for patients with LE, it is not known if the magnitude of acupuncture analgesia provided by one treatment is great enough to improve pain-free grip strength in patients with LE. Therefore, it is not clear whether or not acupuncture analgesia is significant enough to enhance patients’ exercise capacity in rehabilitation. In addition, it hasn’t been studied if the magnitude and duration of acupuncture analgesia of one treatment is dependent on the type of acupuncture applied to patients with LE.   1.6 Objectives 1) to assess the feasibility of the methods and procedures of a study examining the relative effectiveness of EA vs SA for patients with chronic LE; 2) to estimate the expected outcome: (a) by investigating the time course of pain relief provided by EA over a 72 hour period after one treatment; and (b) by assessing if the degree of pain relief produced by EA is associated with pain-free grip strength.  1.7 Hypothesis  (1) EA will produce a greater analgesic effect compared to SA over a 72 hour period after one treatment; and (2) the analgesic effect produced by EA will be associated with an improvement in pain-free grip strength in patients with LE.  1.8 Significance of research We expect that the documented time course of pain relief produced by either SA or EA will provide a basis to determine the best time to incorporate either therapeutic modality in a rehabilitation exercise program, to maximize any existing pain relief and tendon healing effects for patients with LE.   13  Chapter 2: Study design This was a randomized, double-blinded, parallel-group study conducted in Vancouver, British Columbia, Canada. Participants with chronic unilateral LE received one treatment of either EA or SA. Changes in PFGS and the perceived pain level were observed over a 72-hour of period. This study protocol was approved by University of British Columbia Clinical Research Ethics Board (CREB) and registered online at the ISRCTN registry (http://www.isrctn.com/ISRCTN14667535) prior to the start of the clinical trial.   2.1 Recruitment Participants were recruited from the general community through advertising in community centres, gyms, tennis facilities, medical clinics and coffee shops in Vancouver, British Columbia. Interested participants contacted the study team either by telephone or email and underwent a telephone interview to screen for minimal eligibility criteria. A consent form was emailed to those who met the eligibility criteria; and individuals who decided to participate were invited to the Centre for Hip Health and Mobility (CHHM) for further screening and treatment.   2.2  Participants  After obtaining written informed consent from participants, they were screened for their eligibility for the study. A clinician (J.J) confirmed the participants’ eligibility using a questionnaire and performed a physical inspection of the elbow to verify that the participant’s condition was consistent with lateral epicondylalgia.  Inclusion criteria were: 1) unilateral elbow pain at or around the lateral epicondyle of the humerus for more than six weeks, 2) elbow pain provoked by palpation on the lateral epicondyle of humerus and by gripping, 3) elbow pain triggered by either resisted wrist extension or resisted middle finger extension (Haker, 1993), 4) between 19 and 65 years old, and 5) fluent in English.  14  Exclusion criteria were: 1) any other concurrent neck, shoulder, elbow, or arm disorders, 2) injections for LE (e.g. corticosteroid, autologous whole blood, PRP, or prolotherapy), 3) received acupuncture for LE, 4) pregnant, 5) pacemakers or other electrical device implanted in the body, 6) history of seizures or epilepsy, 7) untreated hemorrhagic disorders, 8) infected tissues, osteomyelitis, or wounds around the elbow, 9) active deep vein thrombosis or thrombophlebitis, 10) impaired sensation at and around the elbow, 11) not able to give accurate and timely feedback due to cognition or communication impairment, 12) cancerous lesions at or around the elbow, 13) radiation therapy around the elbow within the previous 6 months, 14) impaired circulation around the elbow, 15) surgery or bone fracture at or around the elbow previously, 16) needle phobia, 17) inflammatory rheumatic diseases, and  18) opioid medications  2.3 Study setting  The study took place between May and December 2015, at the Centre for Hip Health and Mobility (CHHM), a research facility located in Vancouver General Hospital campus, Vancouver, British Columbia, Canada.    2.4 Baseline measurements Prior to receiving treatment, participants were asked to fill out a baseline information sheet, the Patient-Rated Tennis Elbow Evaluation, and the Tampa Scale for Kinesiophobia, and their PFGS and their perceived pain level at the elbow region were measured.   2.5 Baseline information Information about participants’ gender, age, the side of affected arm, hand dominance, duration of LE, and risk factors for LE (employment, sports) was collected.    15  2.5.1 Patient-rated tennis elbow evaluation (PRTEE) PRTEE is a questionnaire used to assess the level of pain and functional disability of the forearm in patients with LE (MacDermid, 2007). A recent study by Chung & Wiley (2010) reported that PRTEE shows questionable sensitivity to change in patients with LE, contradicting the findings of Rompe, Overend, & MacDermid (2007). However, in this study, PRTEE was used for the baseline measurement only for demographic characteristics and was not used to detect changes in the pain level occurring after the intervention.  2.5.2 Tampa scale for kinesiophobia- 11 (TSK-11) TSK-11 is a questionnaire designed to assess pain-related fear (Tkachuk & Harris, 2012). It comprises two subscales- somatic focus and activity avoidance- measuring patients’ belief in their underlying medical condition and in carrying out activities due to fear of re-injury or pain. TSK-11 has demonstrated reliability and validity in patients with chronic pain and with work-related upper extremity disorders (Roelofs et al., 2007; Tkachuk & Harris, 2012).  2.6 Interventions Before their first visit, participants were asked to: 1) refrain from taking NSAIDs or analgesia for three days prior to the study until its completion; 2) avoid any therapy for three days prior to the study until its completion; 3) avoid excessive caffeine intake (no more than 2 cups of coffee) 24 hours before the study and during the 72 hour follow-up; and 4) avoid any activities that aggravate elbow pain for 72 hours after a treatment.  2.6.1 SA After baseline measurements, participants received acupuncture on LI 4, SJ 5, LU 5, LI 10, LI 12, SP 6, and GB 34 (Figure 2.6.1). Acupuncture points were chosen based on a literature review (Davidson et al., 2001; Deadman, Al-Khafaji, & Baker, 1998; Fink et al., 2002; Hacker & Lundeberg, 1990; Irnich et al., 2003; Molsberger & Hille, 1994). Needling was done only on the affected arm and ipsilateral leg. 16  Only sterile, single-use, disposable stainless steel needles were used (Seirin L-type, 40mm x 0.25mm) for both treatment groups. Participants’ skin at the needling sites was cleaned with antiseptic prior to needling. After inserting acupuncture needles into the skin to the required depth (1.5- 3.5 cm), the clinician manipulated the acupuncture needles until the patients feel deqi (“arrival of qi”). Deqi is a subjective feeling of a patient at the region where an acupuncture needle is inserted into the acupoint and it is characterized by aching, soreness, numbness, tingling, pressure, or heaviness – this is typically ascribed to stimulation of peripheral sensory nerves (Bowsher, 1990; Yang et al., 2013). Acupuncture needles were left in place for 30 minutes. Acupuncture points located on the leg (GB 34, SP 6) were re-stimulated with a twirling method, in both treatment groups, once during the middle of treatment. Manipulation of the needles during the treatment was to stimulate acupuncture points, which in turn stimulates peripheral sensory nerves to create pain relief. Acupuncture was performed by a clinician (J.J) who was a registered acupuncturist in British Columbia with over 10 years of experience in clinical practice and teaching acupuncture.   Figure 2.1 Locations of acupuncture points 17  2.6.2 EA Participants in the EA group also received the same treatment as the SA group. The only difference between two groups was that, in the EA group, participants received electro-stimulation between two pairs of acupoints: one pair between LI 10 and LI 12 and the other pair between LI 4 and SJ 5. The negative or black lead was attached to the distal point of each pair (LI 10, LI 4) and the positive or red lead was connected to the proximal point of each pair (LI 12, SJ 5). Electro-stimulation was applied using an electro-acupuncture unit (ES-160) (ITO Physiotherapy and rehabilitation, Japan), which has met the health, and safety requirement set by European standard (CE marking) and is widely used in Canadian clinics (distributor ELECTRO-THERAPEUTIC DEVICES INC). The frequency was set as alternating between 10 and 30Hz (alternating between two frequencies every 3 seconds) and the delivery mode was set as fast and slow. The pulse width was set as 400 microseconds. The intensity was set and maintained at a point at which participants received a sensory stimulus, such as tingling or numbness sensation, without visible muscle contraction. Electro-stimulation was applied for 30 minutes.  These stimulation parameters were based on evidence of efficacy in previous laboratory and clinical studies (Ghoname et al., 1999; Han, 2004; White, Li, & Chiu, 2001; Zhang et al., 2014).   2.7 Randomization At the recruitment stage, participants were told that they would be randomly assigned to receive one of two types of acupuncture treatment both of which previously have been shown to be effective and were informed that this study involved the application of small electrical currents through acupuncture needles. However, details about different types of acupuncture were not given in order to prevent participants’ anticipation bias and to attempt to mitigate the placebo effect. A randomization list of 20 equally weighted allocations was generated by Dr. Alexander Scott using EXCEL program and an allocation table was uploaded to REDCAP prior to the start of the study. 18  The randomization sequence was concealed from the clinician and the randomization was stratified by sex.  2.7.1 Changes to study design Because of low recruitment rate of male participants for the first half of a recruitment period, the initial plan of recruiting the equal number of male (10) and female (10) participants was revised so that I recruited a total of 20 participants regardless sex. Since the original allocation table contained 10 random allocations for male participants and 10 for female, during the study period, an additional randomization list of 20 equally weighted allocations was generated using EXCEL by Dr. Alexander Scott and uploaded to REDCAP in order to have enough group allocations for female participants if needed.  After placement of needles by the clinician, a third person who was not involved in this study was called to the treatment room to witness the completion of needling and the randomization process done through REDCAP thereafter.   2.8 Blinding Efforts to blind participants, the clinician and the assessor were made to minimize potential sources of bias. The effectiveness of blinding methods was determined at the end of the participation of each subject as described below.  2.8.1 Participants Blinding participants who receive electro-stimulation is not possible because of the nature of treatment. In order to minimize the difference between two groups with regard to possible placebo effect generated from knowing the type of treatment they received, participants in the SA group received sham EA: prior to treatment, participants were informed that they would be randomly assigned to different groups after a completion of needling. After a third person witnessed the completion of needling and randomization process through REDCAP, the wires with metal clips were connected to acupuncture needles the same way as in EA group. However, the intensity dials that were connected to these two wires 19  were not manipulated. Instead, the other intensity dials, which were not connected with wires, were turned on so that the ES-160 would still make stimulus sounds as if participants were receiving electrical stimulation. Participants were told that they may or may not feel a tingling sensation due to the use of micro-currents in the study. The electro-stimulator was placed in an opaque box so that participants were not able to watch how the clinician controlled the machine (Figure 2.8.1). In order to find out whether the blinding method was successful or not, participants were asked in the survey “Which group do you think you were belonged to, the EA or SA group?” at the end of the their participation.  Figure 2.2 Sham electro-acupuncture set up 2.8.2 Clinician To avoid clinician bias, the participants’ treatment group allocation was done after all the treatment steps were completed with the exception of the final step of the connecting wires of the e-stimulator to acupuncture needles and the turning on the electro-stimulation current. A third person [C.W, D.L, R.F, V.C, L.W, A.S, P.D, T.A] who was not involved in this study witnessed the placement of needles and a randomization process done through REDCAP database thereafter. 2.8.3 Assessor The assessor was blinded to participant’s group allocation and was not present in the room during the treatment session. The assessor was asked to guess each participant’s group allocation at the end of each participant’s participation in order to find out how successful the blinding was. 20  2.9 Outcome measures  2.9.1 Pain-free grip strength (PFGS) The PFGS test is an indirect way of measuring one’s pain level by assessing the amount of force that a patient can produce with gripping to the onset of pain (Coombes et al., 2009; Wyn Lim, 2013). PFGS is a reliable and valid tool to use in patients with LE: the PFGS test has shown a high test-retest reliability as well as interrater reliability in patients with LE (Smidt et al., 2002; Stratford, 1987; Stratford, Norman, & McIntosh, 1989). Even though there may be inter-individual variability in pain perception with gripping, PFGS has demonstrated a high correlation with pain level and functional ability of the arm in patients with LE (Burton, 1984). In addition, it has demonstrated high sensitivity in assessing changes/progress over time in patients with LE (Stratford & Levy, 1994). PFGS of unaffected and affected arms with LE were taken at baseline, immediately after, 24 hours and 72 hours after the treatment. The assessment time points were selected based on evidence from previous studies (Molsberger & Hille, 1994; Price, Rafii, Watkins, & Buckingham, 1984). Molsberger & Hille (1994) demonstrated that, in patients with chronic LE, SA analgesia lasted on average of 20.2 hours compared to the placebo group of 1.4 hours. In contrast to Molsberger & Hille (1994), Price, Rafii, Watkins, & Buckingham (1984) showed that, in patients with low back pain, EA produced the maximum pain relief 2-24 hours after the treatment and this EA analgesic effect lasted up to 10-14 days. Thus, the expected time course of pain relief was made such that, at 24 hours follow up, both groups will reach the maximum pain relief. Each measurement was repeated three times with 30 second intervals starting with the unaffected arm. Effort to get three consistent readings with less than 10% discrepancy between measurements was made by measuring PFGS more than three times if needed. Encouragement was not given at any time during PFGS measurements of both unaffected and affected arms. PFGS was measured with an electronic digital grip dynamometer (MIE Medical research, UK). Participants were in supine position with the arm adducted, elbow extended, forearm pronated, and wrist extended (Figure 2.9.1). 21  When testing PFGS, we ensured that the dynamometer and forearm were fully supported on the table top. For measurements in the affected arm, participants were instructed to apply force gradually on the grip and stop squeezing as soon as pain was felt; if participants had pain at rest, they were asked to squeeze until the point where their pain first increased; and for measurement of the unaffected arm, they were asked to squeeze the grip maximally.   Figure 2.3 Position for pain-free grip strength measurement 2.9.2 Perceived pain level Perceived pain level was measured on an 11-point Numeric rating scale (NRS). NRS has shown a high test-retest reliability in patients with musculoskeletal disorders of upper limb (Stratford & Spadoni, 2001) and a high interrater reliability in patients with LE (Smidt et al., 2002). Therefore, NRS can be a reliable measure for patients with LE. NRS used for measuring pain upon Thomsen test has shown a good correlation with the Patient-Rated Tennis Elbow Evaluation (PRTEE) pain sub-scale in patients with LE 22  (Rompe, Overend, & MacDermid, 2007). This result suggests that NRS can be a reliable tool to measure pain in patients with LE. The responsiveness of NRS in patients with LE has not studied. However, previous studies found that, for patients with chronic pain, a reduction of either two points or 30% in pain intensity NRS could be considered a clinically important change (Farrar, Young, LaMoreaux, Werth, & Poole, 2001; Salaffi, Stancati, Silvestri, Ciapetti, & Grassi, 2004). This value may be applicable to patients with LE, but this has not been formally examined to our knowledge.  Participants were provided with pain diaries and asked to rate their pain level when making a fist with maximal effort on a scale of 0 to 10 (0= no pain at all and 10= worst pain imaginable). For onsite measurement, participants were in a supine position with the arm adducted, elbow extended, forearm pronated, and wrist extended. The perceived pain level was evaluated after the PFGS measurements. For self-measurement at home, participants were asked to stand straight and position their arms hanging at the side of their body, with their elbow extended, forearm pronated, and wrist extended, when measuring their level of elbow pain. Verbal instructions were given with demonstrations to participants onsite, and the written and visual instructions of the fist test were listed on the first page of their pain diary.  Measurements were taken at baseline, immediately after the treatment, then three times (morning right after wake up, midday, bedtime) a day for 72 hours except during sleep hours.  2.9.3 Global rating of change (GROC)  The GROC scale is a reliable and valid measure of patient’s perceived level of change in their condition over a period of time; and it is commonly used in clinical research and practice. Particularly, a scale with seven points may be a good choice because of its high reliability and validity and its ease of use by patients (Preston & Colman, 2000). Participants were asked “Over the past 24 hours since you received acupuncture treatment, how has your condition changed with respect to your elbow pain?” and were asked to rate on the seven-point Likert type scale- in which seven choices were given - much better, moderately better, slightly better, 23  unchanged, slightly worse, moderately worse, and much worse. Success rate was calculated from the global improvement: ‘much better’ and ‘moderately better’ were considered to be success.   2.9.4 Survey Participants were asked to guess their group allocation and report their confidence level with the answer at the end of their study participation. They had choices of ‘Not confident at all’, ‘Somewhat confident’, ‘Neutral’, ‘Confident’ and ‘Very confident’. In addition, they were questioned: 1) whether they needed to take NSAIDS or any other pain killers for pain control; 2) whether they avoided receiving any therapy; and 3) whether they avoided any activities that aggravate their elbow pain during their participation period.   2.10 Statistical analysis To examine the presence and magnitude of a short-term analgesic effect of EA vs SA, a linear mixed-effects model (repeat measures ANOVA) was used to determine whether there were changes in pain-free grip strength and perceived pain level over a 72-hour period after one treatment of either EA or SA, and whether this change differed between the two treatment groups. The independent variables were time (within-subjects) and treatment (between-subjects). The impact of potential covariates (hand dominance, age, sex, duration of LE, TSK score, PRTEE total score & subscores) were included in the statistical model to determine their potential influence on the outcome measures. P-values were adjusted using the Bonferroni method, and p-values of less than 0.05 were considered statistically significant. Analysis was performed by an independent statistician at the UBC. The data were used to perform a sample size calculation, assuming that the measured treatment effect (EA vs. SA) is the same magnitude as the actual treatment effect.  The following descriptive statistics were also determined – monthly recruitment rate, withdrawal and drop-out rate, success rate of participant and assessor blinding, and incidence of complications. 24  Chapter 3: Results  3.1 Feasibility of procedures  3.1.1 Recruitment  Seventy-two interested participants contacted the research team by phone or email over an eight month period. After telephone screening, 61% of interested participants were excluded either because they did not meet the eligibility criteria, or because they decided not to participate. After further screening onsite, another 25% of participants were excluded. (Figure 3.1.1) Advertisements were posted and reposted every two weeks at different locations such as community centres, gyms, tennis centres/courts, medical clinics, and coffee shops. All community centres and many coffee shops had prominent bulletin boards for community news. Private gyms and medical clinics were more challenging because they seldom allowed the posting of advertisements. This study was also advertised in a local newspaper twice at the beginning of the recruitment period, but this led to only one enrolment. The majority of participants reported that they learned about this study from advertisements posted in coffee shops. Several subjects saw the advertisement at tennis facilities.  The recruitment of male participants during the first four months of the recruitment period was low compared to that of female participants (two vs. seven). Although there was not a large gender difference with regard to the number of participants who initially contacted us (33 male, 37 female, 2 unknown), in the end, fewer male participants were enrolled and underwent a further screening at onsite compared to female (10 male, 18 female) due to a loss of more male participants during the scheduling process. Onsite, 12 out of 18 female participants and 9 out of 10 male participants passed the screening and received the treatment.     25  Figure 3.1 Flow of participants 26  3.1.2 Recruitment rate During a period of eight months from May to December 2015, twenty-one participants were recruited and enrolled in the study, yielding a recruitment rate of 2.6 participants/month.  3.1.3 Retention rate Twenty out of 21 (95%) participants completed the study.  3.1.4 Drop/withdrawal rate One participant dropped out after the first visit due to a family matter, which yielded a withdrawal rate of five percent.  3.1.5 Evaluation of eligibility criteria Forty-two percent of interested participants did not meet the inclusion criteria, for various reasons. The most common reason was bilateral elbow pain. (Figure 3.1.1)  Two participants did not experience elbow pain when making a fist with maximal force (the test used in the pain diary), although they reportedly experienced elbow pain with functional gripping. Thus, due to this problem with the chosen outcome measure it was impossible to observe any changes in pain intensity occurring throughout the study period in those participants.  3.1.6 Randomization All participants received the treatment according to their group allocation. Due to a difficulty of recruiting male participants compared to recruiting female participants, stratified randomization by sex did not work very well and a modification was needed during the study as described previously. The original randomization list was used for allocating nine male participants and the first ten female participants; and the additional randomization list was used for allocating the 11th and 12th female participants. 3.1.7 Baseline measures All participants successfully completed the baseline questionnaires.  27  During the course of the study, it became apparent that the addition of questions regarding use of NSAIDs/painkillers and quality of sleep would have been useful additions to the baseline questionnaire. As a component of the pain diary, we collected information about whether participants took NSAIDS or painkillers and whether their elbow pain disturbed their sleep during the study period. Therefore, collecting the baseline data would have been useful in providing additional estimates regarding the changes of pain intensity experienced by participants.  3.1.8 Outcome measures 3.1.8.1 PFGS During PFGS measurements, the blinded assessor (E.B.) faced technical issues with the PFGS program and computer. A total of 26 incidents of the PFGS program crashing occurred (20 incidents on the unaffected arm and 6 on the affected arm) during the study period, ranging from one to six crashes/measurement on the unaffected arm and one to two crashes/measurement on the affected arm. Thirteen out of 21 participants were affected. Most participants (9) experienced one crash during their measurement. This program crashing was found to be the result of incompatibility of the PFGS program with the computer’s operating system. In addition, there were six incidents where the PFGS values recorded by the software were different from the value displayed during the test. Such problems caused participants to undergo repeated grip measurement tests, more than necessary number of times. On average, each participant repeated the PFGS test 4 times for each arm in order to get three consistent readings. The PFGS was repeated as many as seven times in the affected arm and ten times in the unaffected arm. One participant who had to repeat ten times experienced a program crash six times during grip measurements. Although four readings were obtained from this participant, the last two readings were approximately half of the first two measurements prior to multiple crashes.  These last two PFGS values of the unaffected arm were believed to be influenced by fatigue, and therefore, this participant’s PFGS of unaffected arm was treated as missing data.  28  In addition to technical issues, three participants complained of aggravation of elbow pain during or immediately after PFGS measurements, despite extensive coaching to gradually increase gripping force just until the first onset of pain. This may be related to one of the following reasons: (1) gripping too quickly; (2) holding the grip continuously after the onset of pain at the elbow; or (3) fatigue caused by repeated measurements. Three participants who had fast gripping rates demonstrated less deficit in PGFS (65-78% of normal grip strength) in their affected arm compared to an average PFGS of approximately 40% of normal grip strength for the entire cohort.  3.1.8.2 NRS All subjects were able to rate their pain severity using the NRS while making a maximal fist. However, during the course of the study, it became apparent that the level of pain intensity was different depending on the body position. For onsite measurements, participants were lying on the plinth, such that measures could be taken immediately before and after treatment. For home (pain diary) measurements, subjects did the test in the standing position. Participants reported to us incidentally that the level of pain intensity was different depending on the body position. This could be related to the effects of gravity when standing up, or the influence of different relative angles of shoulder-elbow-wrist between the two testing positions. Because of this, the onsite and home measurements were analyzed separately.  Although the fist test was designed to provide an instantaneous measure of pain that could be easily reproduced in both the laboratory and home settings, a number of participants complained that the test did not reflect the more intense levels of pain they experienced in their daily living. As a result, they tended to change the body or arm position in an attempt to provoke and record their expected level of pain; when participants did not feel the level of pain they expected to have, they often wanted to repeat the test. In addition, records of the time of pain measurements in pain diaries indicated that the participants measured their pain level not necessarily at regular intervals for a 72-hour period. Therefore, data of self-measurements may not reflect the true change of pain intensity level over time.  29  3.1.8.3 GROC GROC was applied at 24 hours follow-up because it was expected that participants would reach maximum pain relief within 24 hours after treatment. However, participants had an even higher PFGS as well as a lower pain intensity level at 72 hours follow-up compared to baseline and at 24 hours follow-up (see below for full description of study outcomes). Thus, the GROC scale was not applied at the ideal time, since participants were apparently gradually feeling better over the 72-hour follow-up period.  3.1.8.4 Survey The majority of participants answered that they adhered to their responsibilities throughout the study period: 1) avoiding taking NSAIDS or painkillers; 2) avoiding receiving any additional therapy; 3) avoiding any activities that might aggravate the elbow pain during the study period. However, the responses of some participants suggest that they might have not answered truthfully. For example, among 15 participants who were employed, eight answered that their job involved repetitive movements of the arm and wrist, one answered that their job involved lifting heavy objects; and three answered that their job involved both types of activity. However, except for one, all of these subjects reported that they were able to avoid any activities that trigger elbow pain, despite the fact that theses activities are widely known to aggravate elbow pain. For instance, one participant answered that she avoided any activities that aggravates her elbow pain, however, she made a note ‘exception: I have to continue to work and this requires using a mouse at computer that does aggravate’.   3.1.9 Safety of procedure This study was completed without any significant adverse or side effects. Six participants (five in EA; one in SA) reported post-treatment soreness at 24 hours follow up. Post treatment-soreness gradually disappeared in all participants by their second follow up at 72 hours. One participant in SA group reported a mild bruising in the needling region.    30  3.1.10 Blinding methods 3.1.10.1 Participants  Ten out of eleven participants in the SA group answered that they received EA treatment with confidence levels of ‘very confident’ (60%), ‘neutral’ (30%) and ‘somewhat confident’ (10%). None of these participants had previously experienced EA or electro-stimulation. One participant in the SA group who guessed her treatment allocation correctly (with a confidence level of ‘neutral’) had previous experience with electro-stimulation treatments. Thus, the method of sham EA used in the current study was effective as long as the participants did not have previous experience with electroacupuncture or electro-stimulation treatment before. All subjects who were allocated to EA guessed correctly that they had received EA with confidence levels of ‘very confident’ (67%) and ‘confident’ (33%).  3.1.10.2 Assessor The assessor guessed the participants’ group allocations correctly 45% of the time (with two ‘somewhat confident’ and seven ‘not confident at all’). Therefore, it can be concluded that the assessor was successfully blinded to the participants’ group allocation.  3.2 Baseline characteristics, outcomes and estimations Data from all 21 participants was analyzed for all outcome measures. All obtained data was used in analysis, and data imputation was not performed for missing values.   3.2.1 Baseline The baseline characteristics of the participants are summarized in Table 3.2.1. Seventy-one percent of participants reported that they participated in sports, and the majority of them were involved in more than one physical activity: the most commonly reported sports were tennis (29%), running (29%), gym exercise (24%), biking (19%), and swimming (14%).   31    Baseline EA group SA group Age (years) 46.5 (9.2) 47.3 (7.5) Sex (Male/Female) 5/5 4/7 Duration (months)  6 (28.6)* 5.2 (3.2) Location of LE (Dominant/non-dominant arm) 6/4 11/0 Employment (employed/not employed) 8/2 7/4 Repeated wrist/arm movements (yes/no) 5/3 6/2 Heavy lifting & carrying (yes/no) 1/7 3/5  Sports (yes/no) 7/3 8/3 TSK-11 (Out of 44) 27.6 (6.3) 25.5 (6.1) PRTEE (total) (out of 100) 52.3 (21.2) 49.5 (20.3) PRTEE (subscale: pain) 26.9 (9.9) 26.7 (10.5) PRTEE (subscale: specific activities) 30.6 (14.8) 19.0  (29.0)* PRTEE (subscale: usual activities) 20.1 (9.7) 17.1 (8.6) PFGS of unaffected arm  (N) 342.2 (128.3) 313.0 (119.5) PFGS of affected arm (N) 109.5 (132.9)* 75.67 (101.5)* NRS  4.7 (3.6) 4.1 (1.5) Table 3.1 Baseline demographic and clinical characteristics - Expressed as mean (standard deviation) except *  - * expressed as median (interquartile range) due to asymmetrical distribution of data 32  3.2.2 Pain-free grip strength There was no difference in PFGS between the EA and SA groups at any time point. In the entire cohort, there was a significant change in PFGS over time (Table 3.2.2 and Figure 3.2.1). Indeed, a pattern of a gradual increase in PFGS (approximately 12N/day) was observed over the 72 hour follow-up period, and a significant improvement of PFGS was demonstrated at 72 hours follow-up (38N, 95% CI [12-73N], p<0.05). None of the potential covariates that were analyzed (hand dominance, age, duration of LE, TSK, PRTEE total, PRTEE pain score, PRTEE specific activities, PRTEE usual activities) changed the results except for gender (men had greater PFGS than women, p< 0.05).   Time Improvement in PFGS (N) compared to baseline Adjusted p-value  Immediately after treatment  12.6 (13.2) 0.77 24hr  24.8 (13.3) 0.25 72hr 37.5 (13.3) 0.03* Table 3.2 Changes in PFGS following treatment - Expressed as mean (SEM)   33   Figure 3.2 Changes in PFGS over time with 95% confidence interval  3.2.3 Perceived pain level There was no difference in perceived pain level between the EA and SA groups at any time point reflected either in on-site pain measurement (NRPS) or the pain-diary. In the entire cohort, there was a statistically significant change in the perceived pain level over time, reflected both in onsite 24hr 72hr200204060PFGSTimeChange from BaselineAfter treatment(N)* (p=0.03)34  measurements (p<0.05) and in the pain diary (p<0.05). Onsite measurements showed that this reduction in pain occurred immediately after treatment (i.e. while the participant was still in position on the treatment plinth), and it was maintained throughout the 72 hour follow-up period (Table 3.2.3 and Figure 3.2.2). The pain diary measurement of pain intensity indicated that from Day 1 midday (after treatment), pain severity continued to decrease during the remaining follow-up period  (Table 3.2.4. and Figure 3.2.3).   Time Changes from baseline in perceived pain level (on NRS)  Adjusted p-value  Immediately post-treatment - 1.14 (0.35) 0.01* 24hr  - 0.99 (0.35) 0.03* 72hr  - 1.59 (0.35) 0.00* Table 3.3 Changes in the perceived pain level (NRS, measured onsite) over the 72 hour follow-up period - Expressed as mean (SEM)            35  Time Change from Day 1 (post-treatment) in perceived pain level (on NRS)  Adjusted p-value Day 1 Bedtime  -0.51 (0.29) 0.70 Day 2 Morning  -0.71 (0.29) 0.26 Day 2 Midday  -0.73 (0.30) 0.25 Day 2 Bedtime  -0.95 (0.30) 0.04* Day 3 Morning  -1.41 (0.29) 0.00* Day 3 Midday  -1.22(0.29) 0.00* Day 3 Bedtime  -1.41 (0.29) 0.00* Day 4 Morning  -1.38 (0.29) 0.00* Table 3.4 Changes in the perceived pain level (NRS, measured using a pain diary) over the 72 hour follow-up period - Expressed as mean (SEM)  36   Figure 3.3 Changes in perceived pain level (onsite) over time with 95% confidence interval    24hr 72hr2.52.01.51.00.5NRS (on site)TimeChange from BaselineAfter Treatment*(p=0.01)*(p=0.03)*(p=0.00)37   Figure 3.4 Changes in perceived pain level (NRS, pain diary) over time with 95% confidence interval   3.2.4 Global rating of change Twenty-four hours after one treatment, the majority of participants reported feeling at least ‘slightly better’ (67% in EA and 54% in SA), but only one subject (SA) reported feeling much better (Table 3.2.5). Day1_bedtime Day2_morning Day2_midday Day2_Bedtime Day3_Morning Day3_Midday Day3_Bedtime Day4_Morning2.01.51.00.50.0NRS (self assessment)TimeChange from Day1 Midday* (p=0.04)* (p=0.00)* (p= 0.00)* (p=0.00)* (p=0.00)38  Group GROC EA  6 slightly better (67%) 2 slightly worse (22%) 1 much worse (11%) SA  1 much better (9%) 5 slightly better (45%) 3 unchanged (27%) 2 moderately worse (18%) Table 3.5 GROC at 24 hours follow up  3.2.5 Sample size calculation for a larger study The required sample size to detect a significant difference between the two groups for the primary outcome measure (PFGS) was calculated with 80% power based on the effect size of the observed outcome as 96 participants per group. This would detect an improvement in PFGS in the EA vs. SA group of 43N, favouring the EA group.  3.2.6 Survey All participants answered that they did not take NSAIDS or any other painkillers for pain control nor received any therapy during the study period. All participants in EA group and all but one in the SA group reported that they avoided any activities that aggravated their elbow pain.  39  Chapter 4: Discussion 4.1 Feasibility of procedures and methods This pilot study is considered to have been completed successfully, in that: 1) the recruitment goal was met within the scheduled time period; 2) the majority of participants completed the study without dropping out; 3) the procedures and methods of study proceeded as planned with only minor modifications and slight shortcoming; and 4) therapeutic interventions did not cause any significant adverse or side effects. This suggests that a large-scale study is feasible if slight modifications are made to this pilot study.  Based on the PFGS scores, this study was (as anticipated) not adequately powered to detect a significant difference in the primary outcome measure, suggesting the possibility of a type II error. In order to detect a difference in the primary outcome measure (PFGS) between the two groups (EA and SA), the required sample size for each group is 96 participants. With the recruitment rate observed in this pilot study, it would take 73.8 months (approximately 6 years) to recruit a total of 192 participants. This pilot study was heavily dependent on advertisements posted in community centres and coffee shops; and the main target region for recruitment was Vancouver. Additional recruitment methods may be considered to speed up the recruitment rate, such as liaising with, and recruiting directly from, medical clinics.  One of the challenges in this pilot study was the recruitment of male participants. Although the number of interested participants between male and female was almost equal, men were less likely to end up participating in the study. Given reasons were: 1) a long travel distance; or 2) conflicts with work schedules. Setting up this study at multiple centres could be considered for the convenience of participants. If the travel distance is short, patients may be more willing to participate in the study. Also, the targeting region for recruitment will be larger, which could enhance the recruitment rate of not only male but also female participants. In addition, providing evening appointments may promote the recruitment of male participants.  40  The blinding method used in this study was successful in the majority of cases. Surprisingly, all participants but one who were allocated to the SA group believed they had received EA. However, the one participant who had previous experience with electro-acupuncture correctly identified the treatment. Although it is perceived as a challenge to blind participants with a treatment modality that induces sensory stimulation, such as EA or transcutaneous electrical nerve stimulation (TENS), findings of previous studies (Deyo, Walsh, Schoenfeld, & Ramamurthy, 1990; Raphael et al., 2011) and our study suggest that blinding participants with a sham electro-stimulation could be successful as long as: 1) the procedure is set up such a way that the participants think that they are getting the real treatment (e.g. set up a machine to produce sham electrical signals or sounds during treatment); and  2) participants do not have previous experience of using a such modality.  To mitigate the potential anticipation bias experienced by this subject, it would be better in future to exclude participants who have previous experience with electro-acupuncture or electro-stimulation therapy.  In the baseline questionnaire, participants were asked if they were employed or not and only those who were employed were asked further about whether their jobs involved: 1) repetitive movements of the wrist and elbow; or 2) lifting and carrying heavy objects. However, one participant pointed out that although she was not employed, her daily routines involved these activities. Considering that predisposing factors for LE could be related to activities outside work, a question about the engagement of activities that aggravate elbow pain should be applied to all participants in future studies.    With regard to the outcome measures, a few points should be considered and several recommendations for improvement can be made for subsequent studies. First, for PFGS measurements, even greater attention should be paid to participant’s gripping techniques, particularly how quickly they squeeze and how soon they release the grip after the onset of pain. Participants who had a fast gripping rate tended to have higher PFGS compared to other participants; also they tended to report post-assessment soreness at the elbow region after PFGS measurements. We were aware of this issue before beginning the study, and yet subjects still struggled with it despite coaching. An initial demonstration and 41  training session of the procedure, prior to the commencement of actual data collection, may therefore be helpful for future studies, as it may not be possible to identify ahead of time subjects who will experience difficulty in learning the correct gripping technique. Or, participants could learn and practice how to grip using a very slow grip rate with the unaffected arm before reproducing the same technique with the affected arm with LE (Vicenzino, personal communication). Second, a different type of grip dynamometer that is reliable and valid could be considered for the grip measurement. Although a computerized grip dynamometer is convenient in obtaining and storing the data, it has a risk of systemic/program errors as observed in our study. Third, the body position for the perceived pain level measurement should be consistent throughout the study period because this could influence the level of the perceived pain; this could be addressed by conducting the onsite NRS measurements in the standing position. Fourth, in order to document the full duration of the effect of acupuncture on pain relief and PFGS, a longer follow up period may be necessary. Fifth, the procedure for self-measurement of pain at home should be reviewed and potentially supplemented with questions regarding worst pain experienced, or pain during functional activities. The rationale for this suggestion is that some of participants complained that the test did not reflect the level of pain they experience in their daily life. Also, whether intentionally or not, some patients were observed to alter the position of their wrist or elbow to try and provoke their expected level of pain. Hence, if self-measurement at home is used in the future study, the instructions should even more clearly underline the importance to participants that they keep their body and arm position completely consistent throughout the study period, and potentially subjects could also be asked to rate their worst pain during each day as a supplemental measurement. Fifth, the GROC scale may be more appropriate to apply at 72 hours follow up since the results suggest the continuous improvement till 72 hours follow up.  In terms of the order of outcome measures, the perceived pain level was measured after the PFGS measurements. Even though PFGS measurement is less aggressive compared to maximum grip strength 42  measurement, the majority of participants reported soreness immediately after PFGS measurements. Thus, the PFGS measure might have interfered with the measurement of pain.  As shown in other acupuncture studies, this pilot study was completed without having any significant adverse or side effects. The cause of post-treatment soreness at the elbow region was not measured. It could be related to: 1) activation of intramuscular C-fibres by the acupuncture needles, 2) irritating the local tendon lesion through repeated PFGS measures, triggering a temporary inflammation,  or 3) central sensitization leading to heightened mechanical hyperalgesia.     4.2 Outcomes  In this double-blinded, randomized controlled feasibility study, no significant difference was detected between two types of acupuncture at any time point during a 72-hour period for any outcome measure. However, statistically significant changes of PFGS and perceived pain level were observed in both groups over a 72-hour period after one treatment. At 72 hours follow-up, increased PFGS by an average of 38± 13N and reduced pain intensity level by an average of 37% were observed. The correlation between PFGS and NRS (onsite) was not statistically significant, although the result suggested a potential relationship between change in PFGS (i.e. improvement of PFGS) and change in pain (i.e. pain relief) following treatment (p=0.06). These results cannot be solely explained by gate control theory and by the effect of acupuncture on the endogenous opioid system as these theories only support the effects of immediate and short-term (for up to 8 hours) pain relief (Carlsson, 2002). Therefore, there may be other factors playing a role in further elevation of pain relief and of improvement in PFGS observed at 72 hours follow-up. In addition, the divergent time course (immediate pain relief, followed by more gradual improvement in PFGS) suggests that there may be more than one mechanism underlying the improvements in these outcomes.  One of the objectives of this study was to examine whether the reduction in pain following EA or SA treatment is associated with an improvement in pain-free grip strength in patients with LE. To 43  determine if the improvement in both pain and PFGS is clinically significant after either EA or SA treatment, the minimally clinically significant change (MCIC) was considered. The MCIC is defined as “. . . . the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient’s management.” (Cook, 2008). Based on previous studies, Tonks (2012) reported that a MCIC of PFGS for patients with LE is 2.1-3kg [21-29N]; and Farrar et al. (2001) suggested that a reduction of 30% in pain intensity level on a NRS could be considered a clinically important change in patients with chronic musculoskeletal pain. Our study demonstrated a significant pain reduction of 33% (95% CI [-50 to -15%], p<0.05) immediately after one treatment of either EA or SA; and this improvement was maintained and slightly improved at 72 hours follow up (37% reduction, 95% CI [-56 to -19%], p<0.05). In contrast to immediate pain reduction, a change in PFGS was not immediate. Instead, there was a pattern of gradual increase of PFGS over a 72-hour period and this change in PFGS became significant at 72 hours follow up (38N, 95% CI [2 to 73N], p<0.05). Considering that MCICs were achieved in both PFGS and pain intensity level (NRS) at 72 hours follow up after one treatment of either EA or SA, investigating the therapeutic effect of a combination of acupuncture and rehabilitation exercise program for patients with LE is needed. Unlike PFGS and NRS, significant changes were not observed in the GROC scale. For GROC, ‘much better’ and ‘moderately better’ were considered as success. At 24 hours follow-up, only one participant reported ‘much better’ and none ‘moderately better’, therefore, one acupuncture treatment did not provide noticeable improvement to patients 24 hours following treatment. Also, 25% of participants reported feeling worse after the treatment at 24 hours follow up for unexplained reasons. Since the results showed greater improvements in both PFGS and perceived pain level at 72 hours follow up, if the GROC was applied at 72 hours follow up, different results might have been obtained.  Price, Rafii, Watkins, & Buckingham (1984) investigated the time course of pain relief provided by EA for patients with lower back pain and found that the maximum analgesic effect of acupuncture was 44  reached within 24 hours after treatment, and lasted up to 10-14 days in the majority of patients. However, in our study, participants tended to have a greater improvement in pain intensity level at 72 hours follow up compared to 24 hours follow up. This result may be related to the facts that: 1) our study population was different, therefore, the pattern and extent of analgesia may differ; 2) subjects altered their tendon-loading activities during the follow-up period, thereby experiencing a temporary improvement in their pain levels which was not directly attributable to the study interventions, and/or 3) repeated measurements of PFGS on the first visit may have obscured the analgesic effect of acupuncture at 24 hours follow up. In fact, 30% of participants reported elbow soreness at 24 hours follow up; and all reported that elbow soreness had disappeared by 72 hours follow up.  The results of our study differed somewhat from those of Molsberger & Hille’s study, in which: 1) patients with LE had more than 50% reduction in pain intensity after one acupuncture treatment, and 2) the average duration of acupuncture analgesia was approximately 20 hours. The reasons for this discrepancy are not known. We can only speculate that it might be related to treatment methods. For example, Molsberger & Hille (1994) used only one acupuncture point on the leg (in the non-segmental region) for the treatment group, in contrast to previous studies and our study in which acupuncture points were chosen either in the segmental region or in both segmental and non-segmental regions (Davidson et al., 2001; Fink et al., 2002; Fink et al., 2002; Irnich et al., 2003). As suggested by Bowsher (1990), the mechanisms of acupuncture analgesia may be different between segmental acupuncture and non-segmental acupuncture. Hence, the different magnitude or duration of analgesic effect might be produced as a result of treatment.  However, this idea should be investigated further to determine whether these two types of acupuncture (segmental vs. non-segmental acupuncture) produce different magnitude and duration of analgesic effects. Although there is no consensus in optimal dose of acupuncture, the duration of needling might influence on the extent of acupuncture analgesic effect (Leung, Kim, Schulteis, & Yaksh, 2008; Lundeberg, 1988). The duration of needling in Molsberger & Hille (1994) was 5 minutes 45  only in contrast to other studies in which 20-30 minutes were spent (Davidson et al., 2001; Fink et al., 2002; Fink et al., 2002; Irnich et al., 2003).   Findings of our study are similar to a previous study by Plaster, Vieira, Alencar, Nakano, & Liebano (2014). They compared the effect of a single treatment of EA vs. SA on patients with knee osteoarthritis and found that both EA and SA provided a significant improvement in pain intensity and mobility after a single treatment; however, no significant differences were found between EA and SA with regard to pain, muscle strength or mobility. As shown in both studies, there may not be a significant difference between EA and SA with regard to the therapeutic effect it produces, however, further study is needed to determine if the cumulative effect of a course of EA and SA treatments produces the same results. Also, as in our study, Plaster et al. (2014) did not include a ‘no treatment’ control group. Therefore, what requires elucidation is whether the improvement presented in both groups was as a result of treatment or was a non-specific effect.  Although our study showed no significant difference in the therapeutic effect between EA and SA after a single treatment, a more full course of treatment may provide different results as was demonstrated by Leung & Tsui (2002): They investigated the effect of EA and SA on patients with LE after a course of treatments (6 treatments/2 weeks) and found that EA produced a significantly greater pain relief as well as improvement of pain-free grip strength compared to SA. However, this study failed to describe their randomization method and did not blind the clinician nor the participants. Therefore, the results may have been biased. Further studies are required to determine the cumulative therapeutic effect of EA vs. SA.  Unlike manipulative physiotherapy, which produced a substantial improvement in PFGS during the application of treatment and a slight reduction immediately after treatment (Vicenzino et al., 2001), one acupuncture treatment produced a gradual increase of PFGS over a 72-hour period. As acupuncture treatment does not have an immediate effect on PFGS after treatment, the way in which acupuncture is implemented in a rehabilitation exercise program should be different than the approach used in 46  manipulative therapy. Future studies are needed to determine whether the addition of acupuncture to a rehabilitation program would provide added benefit over and above rehabilitation alone.  Understanding of pain is complex because there are a variety of factors influencing the individual’s pain and disability experience. Previous studies suggested that anxiety and depression might have a potential effect on altering individual’s pain perception (Kivrak, Kose-Ozlece, Ustundag, & Asoglu, 2016; Thompson, Correll, Gallop,Vancampfort,  & Stubbs, 2016). Considering that patients with LE have shown significantly increased levels of anxiety and depression due to pain and functional disability of the arm (Alizadehkhaiyat, Fisher, Kemp, & Frostick, 2007; Das De, Vranceanu, & Ring, 2013), the results of this study might have been influenced by participants’ psychosocial status. In future studies, how the anxiety and depression levels of patients with LE plays a role in indivual’s pain perception and recovery from LE should be explored.   4.3 Strengths and limitations This is the first study investigating the simultaneous time course of pain relief as well as pain-free grip strength in patients with LE after one acupuncture treatment (SA or EA). This study was completed without any significant change in methods & procedure or significant adverse or side effects. In addition, the results suggest that further investigation of the analgesic effects of acupuncture in patients with LE is needed as the degree of pain relief and improvement in PFGS exceeded the MCIC determined in previous RCTs for LE.  There were some limitations in this study: 1) There was no ‘no treatment’ control group in this study. Therefore, it is not certain whether the observed reduction in pain is due to a treatment effect or a placebo effect. 2) The improvement in PFGS over the ensuing 72 hours may have been due to relative rest. In addition, it may be also related to the participants’ awareness of being observed by researchers. Without having a ‘no treatment/or placebo group’, the Hawthorne effect cannot be ignored as a possible reason for this improvement.  3) Over a 72-hour period, a pattern of gradual increase in PFGS was seen. 47  However, whether PFGS would further increase or decline after a 72-hour period is not known as the study ended at 72 hours follow up; 4) Due to the difference in measurement position for elbow pain onsite versus at home, a separate analysis for onsite measurements and self-measurements at home was conducted. Thus, continuous 72 hour time course of the analgesic effect of either treatment could not be evaluated. In addition, because pain level standing up at onsite was not measured, there was no baseline (prior to treatment) for home measurements; therefore, the analysis subsequent measurements to the day 1 midday value. Therefore, for home measurement, the level of pain relief that was achieved compared to true baseline could not be determined; 5) participants who were admitted to this study may not have had a diagnosis confirmed with imaging. Although only those who met the eligibility criteria were enrolled in the study, it is possible that some of patients might have had elbow conditions other than LE; 6) this study provided one treatment only, and did not include a placebo control (i.e. sham needling). Given that LE is a chronic condition which typically requires several weeks to demonstrate improvement with conservative treatment, the results of this study do not address the effectiveness of EA or SA in treatment of LE as it is typically provided (several times a week for several weeks).  In order to find out whether EA or SA are effective treatments for LE, a long-term, placebo-controlled study is needed.   4.4 Conclusion This pilot study provides guidance and suggestions for refining and developing the study methodology for future large-scale studies of acupuncture for the treatment of LE. The results of this study suggest that there are no differences between EA and SA with regard to the time course of pain relief and improvement of PFGS after one treatment. However, a larger sample study is needed to be confident in the lack of difference between the acute analgesic effects of EA versus SA . In addition, this study does not provide the insight of the effectiveness of EA versus SA in treatment of LE as it takes more than one treatment to affect a chronic tendinopathic condition. A larger and long-term study is 48  needed to investigate whether there is a difference in therapeutic effects between EA and SA when a course of treatments is applied over a few weeks. Even though no difference was observed between the two treatment groups, both groups showed statistically significant improvements in both pain intensity level and PFGS after one treatment. Also, the magnitude of improvements in both pain intensity level and PFGS exceeded the MCIC determined by previous studies (Farrar et al., 2001; Tonks, 2012). Therefore, further research is needed to study the effect of acupuncture in the treatment of LE in conjunction with an exercise program.  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Progress in neurobiology,, 85(4), 355–375. http://doi.org/10.1016/j.pneurobio.2008.05.004  61  Appendices Appendix A   Consent form   Participant Information and Consent Form    The time course of the analgesic effect of acupuncture in treatment of lateral epicondylalgia: a pilot study                  Principal Investigator:  Dr. Alexander Scott, Assistant professor      Department of Physical Therapy                                                    The University of British Columbia    Co-Investigator: Jaewon Jeon, graduate student  Masters program in Rehabilitation Sciences  The University of British Columbia                62  1. Invitation  You are being invited to take part in this research study because you have had lateral elbow pain (i.e. lateral epicondylalgia or “or tennis elbow”) for longer than six weeks.   2. Your participation is voluntary  Your participation is voluntary. You have the right to refuse to participate in this study. If you decide to participate, you may still choose to withdraw from the study at any time without any negative consequences to the medical care, education, or other services to which you are entitled or are presently receiving.  You should be aware that there is a difference for both you and your doctor between being a patient and being a research participant. As a patient all medical procedures and treatments are carried out for your benefit only according to standard accepted practice. As a research participant you and your doctor also must take into account the requirements for the research study. These may include procedures and treatments that are not part of standard practice or are not yet proven. This consent form describes the assessment and treatment procedures that are being carried out for research purposes. Please review the consent document carefully when deciding whether or not you wish to be part of the research and sign this consent only if you accept being a research participant.   If you wish to participate in this study, you will be asked to sign this form.  Please take time to read the following information carefully and to discuss it with your family, friends, and doctor before you decide.   3. Who is conducting this study?  This study is not receiving funds from an external agency or sponsor. Under the direction of Dr. Alexander Scott (the primary investigator of the study), it is being conducted by Jaewon Jeon, who is a certified Traditional Chinese Medical practitioner and a Master of Science student in Rehabilitation Sciences, UBC.   4. Background Lateral epicondylalgia (LE) or tennis elbow is  a condition often caused by repetitive use or overloading of the arm. This condition can lead to limited performance at work and in daily life. For instance, patients with LE often experience pain and difficulties in performing simple daily tasks, such as holding a cup, turning a doorknob, or carrying a bag. LE is a common disorder which affects about 1-3% of the general population with a peak occurrence between the ages of 30 and 50. The prevalence goes up to 20% in industries such as meat processing, fishery, or assembly, where repetitive and strenuous tasks are required. Rehabilitation exercise has shown to improve muscle strength and functional ability of the arm, yet patients’ pain may impair their motivation to participate in exercise program. This limitation can be overcome by combining exercise with a modality that can produce effective pain relief. A conventional treatment, such as corticosteroid injections, has demonstrated a short-term pain relief, however, it is often accompanied by adverse effects: patients who had corticosteroid injections reported to have adverse effects, such as post-injection pain and local skin atrophy(thinning of the skin), as well as a high 63  recurrence rate after one year compared to patients who had no intervention or physical therapy. In addition, topical non-steroidal anti-inflammatory drugs (NSAIDs) may  cause skin irritations and oral NSAIDS can cause side effects, such as diarrhea or abdominal pain. Therefore, an alternative treatment modality which can provide effective pain relief with little or no side effects is needed. Among different alternative modalities available for LE, acupuncture or electroacupuncture can be good options: previous studies have demonstrated that acupuncture can create pain relief by stimulating sensory nerve pathways which culminate in the release of opioid substances in the body, with little or no side effects. In fact, several studies have demonstrated a short-term pain relief provided by both standard acupuncture and electroacupuncture for patients with LE.  Therefore, standard acupuncture or electroacupuncture have the potential to be a good modality to combine with rehabilitation.  Twenty participants will be recruited in this study. Participants will be randomly assigned to either standard acupuncture or electroacupuncture and receive one of two different types of acupuncture treatment, both of which have previously been demonstrated to produce effective pain relief in earlier studies. Participants will receive treatment at a time of their convenience at the Centre for Hip Health and Mobility, located at Vancouver General Hospital.    5. What is the purpose of the study?  We plan to compare the time course of pain relief effects of standard acupuncture vs. electroacupuncture in treatment of LE for a 72-hour period after an intervention. In addition, we will investigate if the degree of pain relief produced by either intervention is significant enough to see changes in your pain-free grip strength.  This research is a pilot study to test the study plan and methods, and to find out whether enough participants will join a larger study. This type of study involves a small number of participants and so it is not expected to prove effectiveness. The results may be used as a guide for larger studies, although there is no guarantee that larger studies will be conducted. Participation in a pilot study does not mean that you will be eligible to participate in a future larger study. Knowledge gained from pilot or feasibility studies may be used to develop future studies that may benefit others.   6. Who can participate in this study?  You may be able to participate in this study if: ▪ You have had lateral elbow pain for longer than six weeks ▪ You are aged between 19 and 65 years old ▪ You are fluent in English  7. Who should not participate in this study?  You will not be eligible to participate in this study if: ▪ you have any other concurrent neck, shoulder, elbow, or arm disorders ▪ You received an injection therapy for tennis elbow ▪ You received acupuncture for tennis elbow ▪ You are pregnant ▪ You have a pacemaker or other electrical device implanted in the body ▪ You have a history of seizures or epilepsy 64  ▪ You have untreated hemorrhagic (bleeding) disorders ▪ You have infected tissues, osteomyelitis, or wounds around the elbow ▪ You have active deep vein thrombosis ▪ You have impaired sensation or circulation at and around the elbow ▪ You are not able to give accurate and timely feedback due to cognition or communication impairment ▪ You have cancerous lesions at or around the elbow ▪ You have received a radiation therapy around the elbow within the previous 6 months ▪ You had surgery or bone fracture at or around the elbow previously ▪ You have a needle phobia (i.e. afraid of needles) ▪ You have inflammatory rheumatic diseases (e.g. rheumatoid arthritis) ▪ You are on opioid medication (e.g. medications containing codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, or oxycodone)    8. What does the study involve? Overall design of the study If you fit the minimal eligibility criteria and if you agree to participate, you will be invited to the Centre for Hip Health and Mobility (CHHM) for screening and treatment. It is possible that after the screening, you may not qualify for the study.  This study involves screening, treatment, and follow-ups:  (1) Screening & Treatment (1st visit) Participants will be screened for their eligibility for the study. You will fill out a questionnaire to determine your eligibility for this study. Then, a clinician (Jaewon Jeon) will conduct a physical inspection of the elbow to check if your condition is consistent with LE. This process will take about 15-30 minutes.  If you are eligible for participation, then, you will be randomly assigned to either the standard acupuncture or electroacupuncture group and receive a treatment. You will have an equal chance of being in either group, and both treatments have previously been shown to result in short-term pain relief. A clinician will measure your pain-free grip strength and the pain level after the treatment.  The study procedure will take about 1.5 hours, including preparation, treatment, and measurement time.  (2) Follow-ups (2nd and 3rd visits) You will be asked to visit the Centre for Hip Health and Mobility (CHHM) 24 hours  and 72 hours after your treatment for the follow-up measurements of your pain-free grip strength and pain level. In addition, you will be provided a pain diary and be asked to record your pain level three times (in the morning after waking up, mid-day, and bedtime) a day for a 72-hour period.   If You Decide to Join This Study: Specific Procedures  If you agree to take part in this study, the procedures and visits you can expect will include the following:  Screening & Study Visit [1st visit] You will be asked to visit the Centre for Hip Health and Mobility, located in Vancouver. After obtaining an informed consent from you, we will ask you to fill out a questionnaire that can help us determine your eligibility for participation in this study. Then, a clinician (Jaewon Jeon) will conduct a brief physical inspection of the elbow to confirm that your condition is consistent with LE. This will take about 15-30 minutes. There is a possibility that after the screening, you may not qualify for the study.    If you are eligible for this study, you will be randomly assigned to either standard acupuncture or electroacupuncture group. You will draw an envelope which contains information about your group allocation. You will have an equal chance of being in either group.  65  Before treatment, you will be asked to fill out a baseline information sheet and the Patient-rated tennis elbow evaluation (PRTEE) form and to rate your pain level on the Numeric rating scale (NRS). Then, the assessor will measure your pain-free grip strength. This procedure may take about 15-30 minutes.   Then, you will receive treatment according to your group allocation. This involves the penetration of skin with acupuncture needles at seven different acupoints. The depth of needling at each point will be about 1-3.5cm into the body. Only sterile, single-use, disposable stainless steel acupuncture needles will be used. Both groups will receive the same acupuncture treatment. The only difference between two groups will be that, in the electroacupuncture group, participants will also receive electro-stimulation over the lateral elbow and hand-forearm regions. This may involve a mild tingling sensation as electrical current is passed through the acupuncture needles. In both groups, this procedure will last about 35-40 minutes.   Immediately after the treatment, the assessor will measure your pain-free hand grip strength and pain level. You can expect that your first visit will take about 1.5 hours.  Expected Follow-ups [2nd & 3rd visits] You will be asked to visit the Centre for Hip Health & Mobility for the measurements of 24 hours and 72 hours after an intervention. The assessor will measure your pain-free grip strength and pain level. In addition, you will be asked to rate the change of your condition over 24 hours after an intervention on the 7-point scale. You can expect that your second and third visits will take about 15 minutes/visit.   You will be asked to fill out the pain diary for 72 hours after treatment. You will record the perceived pain level when you are making a fist with maximal effort on the NRS three times a day (in the morning after waking up, mid-day, and bedtime) for a 72-hour period.  You will be provided a pain diary on the day of treatment. After completion of your diary, you could return your pain diary when you have your second follow-up measurement (72 hours after the treatment) at the Centre for Hip Health and Mobility.  9. What are my responsibilities?  ▪ to avoid taking NSAIDs or painkillers for three days prior to the study until its completion ▪ to avoid any therapy for three days prior to the study until its completion ▪ to avoid excessive caffeine intake (no more than 2 cups of coffee or tea) 24 hours before the treatment and during the 72-hour follow-up ▪ to avoid any activities that aggravate your elbow pain for 72 hours after an intervention   10. What are the possible harms and discomforts?  You may experience: - slight discomfort upon insertion of needles: participants may experience numbness, mild electrical shock sensation that last a few seconds, distension, soreness, and occasional sharp pain - light-headed during or after treatment - mild bleeding, swelling, or bruising (if you are on anticoagulant [blood thinner] medication, you may be more prone to bruising) - allergic reaction to the metal needles, such as rashes or itching of skin - tingling sensation temporarily after electro-stimulation  However, there have been few side effects reported with acupuncture intervention.   66  11. What are the potential benefits of participating?  No one knows whether or not you will benefit from this study. There may or may not be direct benefits to you from taking part in this study. However, you may be able to find out if acupuncture treatment is helpful in pain relief for your elbow pain.    This study is to observe how patients with tennis elbow perceive pain differently over time after an acupuncture intervention and we would like to find out if there is a difference in the degree of pain relief between two different types of acupuncture. Also, we would like to find out if either type of acupuncture may help improve pain-free grip strength.  This information will be useful in finding out if acupuncture is a good modality to combine with rehabilitation exercise program to maximize pain relief and tendon healing in patients with tennis elbow and in determining the best time to incorporate acupuncture into rehabilitation exercise program.  We hope that the information learned from this study can be used in the future to benefit other people with a similar condition.  The results of this study will be provided to you upon your request.    12. What are the alternatives to the study treatment?  If you choose not to participate in this study or to withdraw at a later date, the following treatment options may be available to you through consultation with a medical doctor:  ▪ Corticosteroid injections ▪ Non-steroidal anti-inflammatory drugs (NSAIDS) ▪ Physical therapy ▪ Orthoses (bracing) ▪ Low-level laser therapy  You can discuss these options with your doctor before deciding whether or not to participate in this research project.    14. What happens if I decide to withdraw my consent to participate?  You may withdraw from this study at any time without giving reasons. If you choose to enter the study and then decide to withdraw at a later time, you have the right to request the withdrawal of your information collected during the study. This request will be respected to the extent possible. Please note however that there may be exceptions where the data will not be able to be withdrawn for example where the data is no longer identifiable (meaning it cannot be linked in any way back to your identity) or where the data has been merged with other data. If you would like to request the withdrawal of your data, please let your study doctor know. If your participation in this study includes enrolling in any optional studies, or long term follow-up, you will be asked whether you wish to withdraw from these as well.     67  16. How will my taking part in this study be kept confidential?  Your confidentiality will be respected. However, research records and health or other source records identifying you may be inspected in the presence of the Investigator and UBC Clinical Research Ethics Board for the purpose of monitoring the research. No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law.  You will be assigned a unique study number as a participant in this study. This number will not include any personal information that could identify you (e.g., it will not include your Personal Health Number, SIN, or your initials, etc.). Only this number will be used on any research-related information collected about you during the course of this study, so that your identity will be kept confidential. Information that contains your identity will remain only with the Principal Investigator and/or designate. The list that matches your name to the unique study number that is used on your research-related information will not be removed or released without your consent unless required by law.  Your rights to privacy are legally protected by federal and provincial laws that require safeguards to insure that your privacy is respected. You also have the legal right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available on request to your study doctor.   17. What happens if something goes wrong?  By signing this form, you do not give up any of your legal rights and you do not release the study doctor, participating institutions, or anyone else from their legal and professional duties. If you become ill or physically injured as a result of participation in this study, the costs of your medical treatment will be paid by your provincial medical plan.  In case of a serious medical event, please report to an emergency room and inform them that you are participating in a clinical study and that the following person can then be contacted at any time for further information: Dr. Alexander Scott, Ph.D at telephone number: 604-875-4111, ext.21810   18. What will the study cost me?  All research-related medical care and treatment and any related tests that you will receive during your participation in this study will be provided at no cost to you.  Reimbursement Any personal expenses as a result of participation, such as parking, travel will not be reimbursed.  Remuneration You will be paid $50 upon the completion of your participation in this study. If you withdraw from the study, the payment will be pro-rated.    68  19. Who do I contact if I have questions about the study during my participation?  If you have any questions or desire further information about this study before or during participation, or if you experience any adverse effects, you can contact Jaewon Jeon at 778-999-8381 or via email at jeon8@mail.ubc.ca   20. Who do I contact if I have any questions or concerns about my rights as a participant?  If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the University of British Columbia Office of Research Ethics by e-mail at RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll Free: 1-877-822-8598).   21. After the study is finished  If you would like to receive the study and/or your results, you can leave your email or address with the researcher. When the study is completed, a summary of the study results will be provided via email or by mail.                               69  1. Signatures The time course of the analgesic effect of acupuncture in treatment of lateral epicondylalgia (LE): a pilot study  Participant Consent  My signature on this consent form means: ▪ I have read and understood the information in this consent form.  ▪ I have had enough time to think about the information provided. ▪ I have been able to ask for advice if needed. ▪ I have been able to ask questions and have had satisfactory responses to my questions.  ▪ I understand that all of the information collected will be kept confidential and that the results will only be used for scientific purposes. ▪ I understand that my participation in this study is voluntary. ▪ I understand that I am completely free at any time to refuse to participate or to withdraw from this study at any time, and that this will not change the quality of care that I receive. ▪ I understand that I am not waiving any of my legal rights as a result of signing this consent form.  ▪ I understand that there is no guarantee that this study will provide any benefits to me.  I will receive a signed copy of this consent form for my own records.  I consent to participate in this study.          Participant’s Signature  Printed name  Date           Signature of Person  Printed name  Study Role Date  Obtaining Consent  Investigator Signature         Investigator Signature  Printed name  Date My signature above signifies that the study has been reviewed with the study participant by me and/or by my delegated staff. My signature may have been added at a later date, as I may not have been present at the time the participant’s signature was obtained.  70   Appendix B  Eligibility criteria questionnaire Eligibility Questionnaire   Participant number _____________________     Date:_________________  1. Are you able to read and understand English?                  Yes        No 2. Do you currently have lateral elbow pain?        Yes        No 3. Is your elbow pain affecting one side only or both sides?        One side      Both sides 4. How long have you had this elbow pain? is it longer than 6 weeks?             Yes        No 5. Are you aged between 19 and 65?        Yes         No 6.   Do you currently have any neck, shoulder, elbow, or arm disorder?            Yes         No 7.   Have you received injection therapy for your elbow pain? [e.g. corticosteroid, PRP, prolotherapy, autologous whole blood]        Yes         No 8.   Have you received acupuncture treatment for your elbow pain?        Yes         No 9.  Are you pregnant?        Yes         No 10.  Do you have a pacemaker or other electrical device implanted in the body?        Yes         No 11.  Have you had a surgery in your affected arm?         Yes         No 12. Have you fractured your affected arm before?        Yes         No  13. Do you have currently have any infection or wounds around your elbow?            Yes         No  71  14.  Have you ever had a seizure? or epilepsy?        Yes         No 15.  Do you have untreated hemorrhagic/bleeding disorders?        Yes         No 16.  Do you have active deep vein thrombosis or thrombophlebitis?        Yes         No 17.  Have you received a radiation therapy around the elbow within the previous 6 months?        Yes         No 18.  Do you have a needle phobia?        Yes         No 19.  Do you have impaired sensation and/or circulation to your arm?         Yes         No 20.  Do you have inflammatory rheumatic disease? e.g. rheumatoid arthritis        Yes         No 21.  Do you have cancerous lesions at or around the elbow?        Yes         No 22.  Do you have infections or wounds around the elbow?        Yes         No 23. Are you on opioid medications, such as morphine, methadone, Buprenorphine, hydrocodone, and oxycodone?         Yes         No  24. Are you currently receiving any therapy for your elbow pain?        Yes         No      * If yes, are you willing to stop receiving therapy for three days prior to the study and until its completion?         Yes         No 25.  Are you taking NSAIDS or any painkiller medication to relieve your elbow pain?        Yes         No     * If yes, are you willing to refrain yourself from taking NSAIDS or other painkiller medications  for three days prior to the study and until its completion? [This study will take 3 days for its completion]        Yes         No   72  26. Are you a habitual coffee drinker?        Yes         No     * If yes, are you willing to avoid drinking coffee (no more than 2 cups/day) 24 hours before the study and during the 72 hours follow-up?               Yes         No          __________________________________________________________________________________ Lateral epicondylalgia physical inspection: A. Palpation      Positive  Negative   B. Gripping test      Positive  Negative   C. Resisted wrist extension     Positive  Negative   D. Resisted middle finger extension   Positive  Negative    73   Appendix C  Baseline information sheet  Participant number: _____________________  Date:________________  Baseline information  This information will help us determine the characteristics of participants in this study. Please check (✔ ︎) the box that is applicable to you or fill in the blanks. Thank you!  1. Gender   ☐ male     ☐ female    2. Birth month ☐ Jan  ☐ Feb ☐ Mar ☐ Apr  ☐ May  ☐ Jun    ☐ Jul  ☐ Aug  ☐ Sep  ☐ Oct  ☐ Nov  ☐ Dec   3. Birth year: ___________________  4. Which arm do you have lateral elbow pain?   ☐ Left  ☐ Right   5. Are you left-handed or right-handed?   ☐ Left ☐ Right ☐ Ambidextrous    6. How long have you had lateral elbow pain?     ________ weeks or ________ months  7. Are you currently employed?   ☐ Yes (Please specify:    ) ☐ No            7.1. If yes, does your work/job involve the repetitive movement of your wrist and/or elbow?    ☐ Yes      ☐ No     7.2. If yes, does your work/job involve lifting or carrying?       ☐ Yes      ☐ No   8. Do you do any sports?    ☐ Yes (Please specify:   ) ☐ No   8.1. If yes, what is your level of competition?   ☐ recreational ☐ professional ☐ elite  (competing at provincial level or higher)    74   Appendix D   Patient-Rated Tennis Elbow Evaluation (PRTEE) PATIENT-RATED TENNIS ELBOW EVALUATION   Participant number:_______________________________; Date:_______________________   The questions below will help us understand the amount of difficulty you have had with your arm in the past week. You will be describing your average symptoms over the past week on a scale 0-10. Please provide an answer for all questions. If you did not perform an activity because of pain or because you were unable, then you should circle a “10”. If you are unsure, please estimate to the best of your ability. Only leave items blank if you never perform that activity. Please indicate this by drawing a line completely through the question.   1. PAIN in your affected arm Rate the average amount of pain in your arm over the past week by circling the number that best describes your pain on a scale from 0-10. A zero(0) means that you did not have any pain and a ten(10) means that you had the worst pain imaginable.  RATE YOUR PAIN:  No pain                                                                                 Worst pain                                                                                               imaginable When you are at rest        0       1       2       3       4       5       6       7       8       9       10 When doing a task with repeated arm movement        0       1       2       3       4       5       6       7       8       9       10 When carrying a plastic bag of groceries        0       1       2       3       4       5       6       7       8       9       10 When your pain was at its least        0       1       2       3       4       5       6       7       8       9       10 When your pain was at its worst        0       1       2       3       4       5       6       7       8       9       10    75  2. FUNCTIONAL DISABILITY A. SPECIFIC ACTIVITIES Rate the amount of difficulty you experienced performing each of the tasks listed below, over the past week, by circling the number that best describes your difficulty on a scale of 0-10. A zero(0) means you did not experience any difficulty and a ten(10) means it was so difficult you were unable to do it at all. 	   No                                                                                   Unable Difficulty                                                                         To Do Turn a doorknob or key            0      1      2      3      4      5      6      7      8      9      10 Carry a grocery bag or briefcase by the handle            0      1      2      3      4      5      6      7      8      9      10 Lift a full coffee cup or glass of milk to your mouth            0      1      2      3      4      5      6      7      8      9      10 Open a jar            0      1      2      3      4      5      6      7      8      9      10 Pull up pants            0      1      2      3      4      5      6      7      8      9      10 Wring out a washcloth or wet towel            0      1      2      3      4      5      6      7      8      9      10 B. USUAL ACTIVITIES Rate the amount of difficulty you experienced performing your usual activities in each of the areas listed below, over the past week, by circling the number that best describes your difficulty on a scale of 0-10. By “usual activities”, we mean the activities that you performed before you started having a problem with your arm. A zero (0) means you did not experience any difficulty and a ten (10) means it was so difficult you were unable to do any of your usual activities. 1. Personal activities (dressing, washing)            0      1      2      3      4      5      6      7      8      9      10 2. Household work (cleaning, maintenance)            0      1      2      3      4      5      6      7      8      9      10 3. Work (your job or everyday work)            0      1      2      3      4      5      6      7      8      9      10 4. Recreational or sporting activities            0      1      2      3      4      5      6      7      8      9      10  Comments:      (This form is adopted from @MacDermid 2005)     76  Appendix E  Tampa Scale of Kinesiophobia – 11 (TSK-11) Tampa Scale- 11 (TSK-11)  Please circle the number that best describes how you feel about each statement.  	   Strongly Disagree Disagree Agree Strongly Agree 1. I’m afraid that I might injure my self if I exercise 1 2 3 4 2. If I were to overcome it, my pain would increase 1 2 3 4 3. My body is telling me I have something dangerously wrong 1 2 3 4 4. People aren’t taking my medical condition seriously enough 1 2 3 4 5. My accident/problem has put my body at risk for the rest of my life 1 2 3 4 6. Pain always means I have injured my body 1 2 3 4 7. Simply being careful that I do not make any unnecessary movements is the safest thing I can do to prevent my pain from worsening 1 2 3 4 8. I wouldn’t have this much pain if there wasn’t something potentially dangerous going on in my body 1 2 3 4 9. Pain lets me know when to stop exercising so that I don’t injure myself 1 2 3 4 10. I can’t do all the things normal people do because it’s too easy for me to get injured 1 2 3 4 11. No one should have to exercise when he/she is in pain 1 2 3 4    77   Appendix F  Pain diary Participant number: ______________________________; Date:___________________   INSTRUCTIONS                               Pain Diary You will be using this pain diary to record your elbow pain level throughout a 72-hour period after your treatment. There are three entries per day for you to fill out.  When you return to the Centre for Hip Health and Mobility for your follow-up measurement (72 hours after the treatment), please bring this completed diary with you. Thank you very much for your participation in this study!  Please remember to try and avoid doing any activities that could aggravate your pain for 72 hours following acupuncture.  For measuring your pain level at the elbow, please follow the instructions below: 1) Stand straight 2) Let your arms hang right next to your body 3) Keep your elbow straight 4) Position your forearm in a way that your palm is facing the back 5) Make sure your arm position is the same as shown in the picture below.  5) Make a fist with maximal effort without scrunching your body! (Release as soon as you feel the onset of pain) 6) Rate your pain level      on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.     78  INSTRUCTIONS                                Pain Diary Please circle the number that represents the level of your elbow pain when you are making your fist with maximal effort.  DAY 1: Onsite pain measurement   Baseline/Before treatment    Time of measurement: __________________              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable  Immediately after treatment  Time of measurement:________________              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable   DAY 2: Onsite pain measurement  Time of measurement: __________________               0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable   DAY 4: Onsite pain measurement  Time of measurement: __________________               0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable       79   Self-measurement of pain: DAY 1  Please circle the number that represents the level of your elbow pain when you are making your fist with maximal effort. Please see the instructions on the first page.  Mid-day (if applicable)     Time of measurement:_____________               0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable  Bedtime       Time of measurement:______________               0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable  Did you consume coffee, tea, or caffeinated drink today? If no, please check (✔) . If yes, please indicate the number that represents the amount of your consumption (# of cups).     ☐ 0  ☐ 1  ☐ 2  ☐ more (please specify:   )    Did you wake up at night due to elbow pain?  • if your answer is yes, how would you rate your pain level on a scale of 0 to 10 at the  time of wake-up?              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable          80   Self-measurement of pain: DAY 2 Please circle the number that represents the level of your elbow pain when you are making your fist with maximal effort. Please see the instructions on the first page.   In the morning when you wake up             Time of measurement:_______________             0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable   Mid-day      Time of measurement:_______________              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable  Bedtime      Time of measurement:_______________              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable    Did you consume coffee, tea, or caffeinated drink today? If no, please check (✔). If yes, please indicate the number that represents the amount of your consumption (# of cups).     ☐ 0  ☐ 1  ☐ 2  ☐ more (please specify:   )    Did you wake up at night due to elbow pain?  • if your answer is yes, how would you rate your pain level on a scale of 0 to 10 at the  time of wake-up?              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable     81    Self-measurement of pain: DAY 3 Please circle the number that represents the level of your elbow pain when you are making your fist with maximal effort. Please see the instructions on the first page.   In the morning when you wake up             Time of measurement:_______________             0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable    Mid-day      Time of measurement:_______________              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable  Bedtime      Time of measurement:_______________              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable    Did you consume coffee, tea, or caffeinated drink today? If no, please check (✔). If yes, please indicate the number that represents the amount of your consumption (# of cups).     ☐ 0  ☐ 1  ☐ 2  ☐ more (please specify:   )    Did you wake up at night due to elbow pain?  • if your answer is yes, how would you rate your pain level on a scale of 0 to 10 at the  time of wake-up?              0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable     82   Self-measurement of pain: DAY 4 Please circle the number that represents the level of your elbow pain when you are making your fist with maximal effort. Please see the instructions on the first page.   In the morning when you wake up             Time of measurement:_______________             0    1    2    3     4      5      6      7      8      9      10           no               worst pain at all                                pain imaginable         83   Appendix G  Global rating of change Participant number: ____________________________; Date:____________________   Global rating of change scale     Over the past 24 hours since you received acupuncture treatment, how has your condition changed with respect to your elbow pain? Please circle the word that best describes the change of your condition.      84  Appendix H  Survey Survey Participant number: ____________________________; Date:____________________ 1. Which group do you think you belonged to, the electroacupuncture or standard acupuncture group? Please check (✔) your answer in the box.  ☐ electroacupuncture group    ☐ standard acupuncture group  2. Did you have to take NSAIDS (e.g. Aspirin, Advil, Motrin, Naprosyn) or any other painkillers (e.g. Tylenol) for pain control for the last 72 hours? Please check (✔) your answer in the box.   ☐ Yes       ☐ No  2.1. If your answer is yes, when did you take it? Please check (✔) your answer(s) in the box.    ☐ within 24 hours after the treatment  ☐ within 48 hours after the treatment  ☐ within 72 hours after the treatment   3. Did you avoid receiving any therapy during this study period? Please check (✔) your answer in the box.   ☐ Yes       ☐ No  4. Did you avoid any activities that aggravate your elbow pain during this study period? Please check (✔) your answer in the box.    ☐ Yes       ☐ No     

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