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Open Access Highly Accessed Study protocol

Effect of electroacupuncture on opioid consumption in patients with chronic musculoskeletal pain: protocol of a randomised controlled trial

Charlie CL Xue1, Robert D Helme2, Stephen Gibson3, Malcolm Hogg4, Carolyn Arnold5, Andrew A Somogyi6, Cliff Da Costa7, Yanyi Wang1, Shao-chen Lu1 and Zhen Zheng1*

Author Affiliations

1 Traditional and Complementary Medicine Research Program, Health Innovations Research Institute (HIRi), School of Health Sciences, RMIT University, Bundoora, VIC, Australia

2 Department of Medicine, Royal Melbourne Hospital, Parkville, VIC, Australia

3 National Ageing Research Institute, Parkville, VIC, Australia

4 Pain Services, Royal Melbourne Hospital, Parkville, VIC, Australia

5 Caulfield Pain Management and Research Centre, Caulfield Hospital, Caulfield, VIC, Australia

6 Discipline of Pharmacology, School of Medical Sciences, University of Adelaide, Adelaide, SA, Australia

7 School of Mathematical and Geospatial Sciences, RMIT University, Bundoora, VIC, Australia

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Trials 2012, 13:169  doi:10.1186/1745-6215-13-169

Published: 17 September 2012

Abstract

Background

Chronic musculoskeletal pain is common and has been increasingly managed by opioid medications, of which the long-term efficacy is unknown. Furthermore, there is evidence that long-term use of opioids is associated with reduced pain control, declining physical function and quality of life, and could hinder the goals of integrated pain management. Electroacupuncture (EA) has been shown to be effective in reducing postoperative opioid consumption. Limited evidence suggests that acupuncture could assist patients with chronic pain to reduce their requirements for opioids.

The proposed research aims to assess if EA is an effective adjunct therapy to standard pain and medication management in reducing opioids use by patients with chronic musculoskeletal pain.

Methods

In this multicentre, randomised, sham-acupuncture controlled, three-arm clinical trial, 316 patients regularly taking opioids for pain control and meeting the defined selection criteria will be recruited from pain management centres and clinics of primary care providers in Victoria, Australia. After a four-week run-in period, the participants are randomly assigned to one of three treatment groups to receive EA, sham EA or no-EA with a ratio of 2:1:1. All participants receive routine pain medication management delivered and supervised by the trial medical doctors. Twelve sessions of semi-structured EA or sham EA treatment are delivered over 10 weeks. Upon completion of the acupuncture treatment period, there is a 12-week follow-up. In total, participants are involved in the trial for 26 weeks. Outcome measures of opioid and non-opioid medication consumption, pain scores and opioid-related adverse events are documented throughout the study. Quality of life, depression, function, and attitude to pain medications are also assessed.

Discussion

This randomised controlled trial will determine whether EA is of significant clinical value in assisting the management of debilitating chronic pain by reducing opioids consumption and their associated adverse events, as well as improving the quality of life for those with chronic pain. Such an outcome will provide the rationale for including EA into multidisciplinary programmes for effective management of chronic musculoskeletal pain.

Trial registration

Australian New Zealand Clinical Trial Registry (ACTRN12609000676213)

http://www.anzctr.org.au/trial_view.aspx?ID=308008 webcite

Keywords:
Acupuncture; Chronic pain; Electroacupuncture; Opioid medication; Pain education; Randomised controlled trial