Abstract

Background. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3%. Methods/Design. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months' duration) lateral elbow pain. Four study sites, in the People's Republic of China, Hong Kong, Italy, and Australia, will recruit 24 participants each. A total of 96 participants will be randomised to either an acupuncture group or a sham laser control group. The primary outcome measure will be the Disabilities of Arm, Shoulder, and Hand questionnaire with secondary outcome measures of Pain-Free Grip Strength Test, Muscle Tension Test, and a pain visual analogue scale. Discussion. Key features for conducting a multisite international acupuncture randomised clinical trial have been detailed in this protocol. Trial Registration. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013.

Highlights

  • Lateral elbow pain (LEP, frequently but incorrectly termed lateral epicondylitis or tennis elbow) is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3% [1]

  • In a publication by the United States National Institutes of Health, it was determined that acupuncture may be useful as an adjunct treatment or an acceptable alternative treatment for tennis elbow [5]

  • Each site has completed data collection and double entry data sheets have been uploaded to the digital repository for analysis which has been conducted. This is the first time to our knowledge that a protocol for a multisite international acupuncture randomised clinical trial has been developed in English

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Summary

Introduction

Lateral elbow pain (LEP, frequently but incorrectly termed lateral epicondylitis or tennis elbow) is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3% [1]. Acupuncture has become increasingly recognised as an alternative treatment for pain, including LEP [4]. In the past 15 years, acupuncture has become increasingly recognised as an alternative treatment for pain, including pain from lateral elbow tendinosis. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3%. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months’ duration) lateral elbow pain. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013

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