Abstract
BackgroundChronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain.Methods/DesignTwo hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group) and received no acupuncture treatment. The other three were treatment groups: i) laser acupuncture, ii) sham laser or, iii) needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8–12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS) and self-reported physical function measured by the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale) and physical function (NRS). Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 months.DiscussionThe findings from this study will help determine whether laser and/or needle acupuncture is efficacious, and cost-effective, in the management of chronic knee pain in older people.Trial registrationAustralian New Zealand Clinical Trials Registry reference: ACTRN12609001001280
Highlights
Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause
The findings from this study will help determine whether laser and/or needle acupuncture is efficacious, and cost-effective, in the management of chronic knee pain in older people
The primary hypotheses are that: H1: Laser acupuncture will result in significantly greater improvements in pain (as measured overall via numerical rating scale (NRS)) and physical function (as measured via Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index) than sham laser acupuncture at 12 weeks
Summary
This paper has presented the theoretical rationale, as well as the protocol, for an ongoing Zelen design RCT that is testing the efficacy of a combined Western and Traditional Chinese Medicine style of acupuncture for managing chronic knee pain and disability symptoms in older people. This study will determine whether effects of acupuncture can be maintained over the longer term, and whether psychosocial factors influence treatment outcomes. The use of the Zelen design will minimize the bias typically encountered in traditionally designed RCTs where participant expectations may influence study outcomes. Authors’ contributions RSH, PM, KMC and KLB conceived the project and PM is leading the coordination of the trial. RSH and KLB wrote the first draft of the manuscript. RSH wrote the final draft of this manuscript. All authors participated in the trial design, provided feedback on drafts of this paper and read and approved the final manuscript
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