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

Trials

Zhen Zheng²  Shao-chen Lu²  Yanyi Wang²  Cliff Da Costa⁵  Andrew A Somogyi⁴  Carolyn Arnold⁷  Malcolm Hogg¹  Stephen Gibson⁶  Robert D Helme³  Charlie CL Xue² 

[1] Pain Services, Royal Melbourne Hospital, Parkville, VIC, Australia;Traditional and Complementary Medicine Research Program, Health Innovations Research Institute (HIRi), School of Health Sciences, RMIT University, Bundoora, VIC, Australia;Department of Medicine, Royal Melbourne Hospital, Parkville, VIC, Australia;Discipline of Pharmacology, School of Medical Sciences, University of Adelaide, Adelaide, SA, Australia;School of Mathematical and Geospatial Sciences, RMIT University, Bundoora, VIC, Australia;National Ageing Research Institute, Parkville, VIC, Australia;Caulfield Pain Management and Research Centre, Caulfield Hospital, Caulfield, VIC, Australia

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

Others  :  1095334
DOI  :  10.1186/1745-6215-13-169

 received in 2012-04-27, accepted in 2012-08-13,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Xue et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Blyth FM: Chronic pain in Australia: a prevalence study. Pain 2001, 89:127-134.
• [2]Musculoskeletal conditions in Australia: a snapshot Australian Bureau of Statistics.http://www.abs.gov.au/ausstats/abs@.nsf/mf/4823.0.55.001 webcite.
• [3]Caudill-Slosberg MA, Schwartz LM, Woloshin S: Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain 2004, 109:514-519.
• [4]Blyth FM, March LM, Cousins MJ: Chronic pain-related disability and use of analgesia and health services in a Sydney community. MJA 2003, 179:84-87.
• [5]Statistics on drug use in Australia 2002. http://www.aihw.gov.au/publications/index.cfm/title/8390 webcite.
• [6]Graziotti P, Goucke R: The use of oral opioids in patients with chronic nonmalignant pain: management strategies. 2008. http://www.apsoc.org.au/pdfs/opioid.pdf webcite.
• [7]Kalso E, Edwards JE, Moore RA, McQuay HJ: Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain 2004, 112:372-380.
• [8]Nobel M, Tregear SJ, Treadwell JR, Schoelles K: Long-term opioid therapy for chronic noncancer pain: a systematic review and meta-analysis of efficacy and safety. J Pain Symptom Manage 2008, 35:214-228.
• [9]Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA: Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med 2007, 146:116-127.
• [10]Jensen MK, Thomsen AB, Højsted J: 10-year follow-up of chronic non-malignant pain patients: opioid use, health related quality of life and health care utilization. Eur J Pain 2006, 10:423-433.
• [11]Moore RA, McQuay HJ: Prevalence of opioid adverse events in chronic non-malignant pain; systematic review of randomised trials of oral opioids. Arthritis Res Ther 2005, 7:R1045-R1051.
• [12]Pomeranz B, Chiu D: Naloxone blocks acupuncture analgesia and causes hyperalgesia: endorphin is implicated. Life Sci 1976, 19:1757-1762.
• [13]Mayer DJ, Price DD, RafII A: Antagonism of acupuncture analgesia in man by the narcotic antagonist naloxone. Brain Res 1977, 121:368-372.
• [14]Han JS: Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci 2003, 26:17-22.
• [15]Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK: Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci 2007, 27:10000-10006.
• [16]Harris R, Scott D, Gracely R, Clauw D, Zubieta J: Differential changes in mu-opioid receptor (MOR) availability following acupuncture and sham acupuncture therapy in fibromyalgia (FM) patients. J Pain 2007, 8:S24. Abstract No 692.
• [17]Lin JG, Lo MW, Wen YR, Hsieh CL, Tsai SK, Sun WZ: The effect of high and low frequency electroacupuncture in pain after lower abdominal surgery. Pain 2002, 99:509-514.
• [18]Wang B-G, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender R: Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg 1997, 85:406-413.
• [19]Zheng Z, Gou RXJ, Helme RD, Muir A, Da Costa C, Xue CCL: The effect of electroacupuncture on opioid-like medication consumption by chronic pain patients: a pilot randomized controlled clinical trial. Eur J Pain 2008, 12:671-676.
• [20]Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001, 134:657-662.
• [21]Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS, Hewitt DJ, Jadad AR, Katz NP, Kramer LD, Manning DC, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robinson JP, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Witter J: Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 2003, 106:337-345.
• [22]Furlan AD, Sandoval JA, Mailis-Gagnon A, Tunks E: Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ 2006, 174:1589-1594.
• [23]Fleming S, Rabago DP, Mundt MP, Fleming MF: CAM therapies among primary care patients using opioid therapy for chronic pain. BMC Complement Altern Med 2007, 7:15. BioMed Central Full Text
• [24]MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R: Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med 2001, 9:246-249.
• [25]Twycross RG: Opioids. In Textbook of Pain. 4th edition. Edited by Wall PD, Melzack R. Edinburgh: Churchill Livingstone; 1999:1187-1214.
• [26]McHorney CA, Ware JE, Lu IF, Sherbourne CD: The MOS 36-item Short-Form Health Survey (SF-36): III tests of data quality, scaling assumption and reliability across diverse patients groups. Med Care 1994, 32:40-66.
• [27]Beck AT, Steer RA, Ball R, Ranieri W: Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess 1996, 67:588-597.
• [28]Jensen MP: Validity of the sickness impact profile Roland scale as a measure of dysfunction in chronic pain patients. Pain 1992, 50:157-162.
• [29]Gossop M: The development of a Short Opiate Withdrawal Scale (SOWS). Addict Behav 2001, 15:487-490.
• [30]Jensen MP, Turner JA, Romano JM, Lawlder B: Relationship of pain-specific beliefs to chronic pain adjustment. Pain 1994, 57:301-309.
• [31]Harden RN, Weinland SR, Remble TA, Houle TT, Colio S, Steedman S, Kee WG: Medication Quantification Scale Version III: update in medication classes and revised detriment weights by survey of American Pain Society Physicians. J Pain 2005, 6:364-371.
• [32]Bennett M: The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain 2001, 92:147-157.