Abstract

BackgroundChronic 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.MethodsIn 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trial Registry (ACTRN12609000676213)http://www.anzctr.org.au/trial_view.aspx?ID=308008

Highlights

  • Chronic musculoskeletal pain is common and has been increasingly managed by opioid medications, of which the long-term efficacy is unknown

  • When used in postoperative pain, electroacupuncture (EA) - acupuncture combined with electrical stimulation - reduced the use of postoperative morphine by more than 60% and was 30% better than sham procedures

  • Opioid medication (OM) have been increasingly prescribed for patients with chronic musculoskeletal pain (CMP) both in Australia and worldwide

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Summary

Methods

The trial is being conducted between July 2009 and December 2012, and has been approved by the Human Research Ethics Committees of Melbourne Health (2009.033), Alfred Health (80.09) and the RMIT University (06/09) to be conducted at the Pain Services of the Royal Melbourne Hospital, the Caulfield Pain Management and Research Centre of the Caulfield Hospital, the Sunshine Hospital, and various sites in Melbourne and Geelong. An Acupuncture Treatment Manual has been developed for training acupuncturists; and the Pain and Medication Management Information Brochure is used for training MDs. Co-interventions Co-interventions are discouraged. Withdrawal Participants who find their pain significantly worse or cannot tolerate EA may terminate their involvement in the study They are assessed by one of the MDs with advice on alternative management strategies for their condition. OM: opioid medication; EA: electroacupuncture; SF-36v2: 36-item Short-Form Health Survey version 2; S-LANSS: self-report Leeds Assessment of Neuropathic Symptoms and Signs; W: week. Assessment of safety and report of serious adverse events An AE record form is attached to the end of the Medication and Pain Diaries so that participants can record any unexpected signs, symptoms and feelings during and after the treatment period. The relationship between OM reduction and attitude to pain are explored

Discussion
Background
Blyth FM
14. Han JS
25. Twycross RG
29. Gossop M
Findings
32. Bennett M
Full Text
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