Evaluating the effectiveness of acupuncture in the treatment of low back pain
This picture shows Hugh MacPherson, Lucy Thorpe and Kate Thomas with one of the patients of the trial
Back pain is a major cause of ill health and time lost from work. The conventional medical treatments often have limited success and the NHS has identified back pain as a priority condition for research.
In preparation for a randomised controlled trial, the Foundation carried out a feasibility study (Fitter & MacPherson, 1995) followed by a larger pilot study (MacPherson et al 1999). With Kate Thomas, then of the Medical Care Research Unit at Sheffield University, as Principal Investigator, and funded by the Department of Health R & D Health Technology Assessment Programme, we conducted a pragmatic randomised controlled trial to evaluate the clinical impact and cost effectiveness of acupuncture for chronic low back pain, publishing the protocol in 1999 (Thomas et al 1999).
In the full-scale trial, we recruited 43 general practitioners who referred 241 patients for up to 10 acupuncture treatments provided by six local acupuncturists. Patients were randomised to either acupuncture or usual GP care alone. The key outcome measure was bodily pain, as measured by the SF-36, at 12 and 24 months after randomisation.
Adjusting for baseline score and for any clustering by acupuncturist, the estimated intervention effect was +5.6 points (95% CI –0.2 to 11.4, p=0.06) in favour of acupuncture at 12 months, increasing to +8.0 points (95% CI 2.8 to 13.2 p=0.003) at 24 months. Acupuncture patients also reported a significantly greater reduction in worry about their back pain. In addition, the acupuncture service was found to be cost-effective.
These results have now been published as a monograph by the Health Technology Assessment Programme (Thomas et al 2005) and in two British Medical Journal articles (Thomas et al 2006, Ratcliffe et al 2006).
In a sub-study we have set out the full description of actual treatments provided in the trial as well as explored the traditional acupuncture diagnostic concordance between the acupuncturists. (MacPherson et al 2004) We have also followed up patients for a further six years, and found the effects of acupuncture were reduced to the point of no longer being significant (Prady et al 2007). In sub-studies we used survey methods to explore recruitment issues (Bell-Syer et al 2008), and qualitative methods to explore the practitioner experience (MacPherson et al 2006) and the role of lifestyle advice as an aspect of the acupuncture intervention.(MacPherson & Thomas 2008) And finally, we report on the factors that support, or act as barriers, to acceptability.(Hopton et al 2013)
Impact on policy
In 2009 National Institute for Health and Clinical Excellence (NICE) recommended that acupuncture should be offered to people with persistent low back pain. This recommendation was based on evidence from our trial (p.157):
“The strongest evidence comes from the Thomas paper who included the correct population and was well conducted…. A well-conducted UK based cost effectiveness analysis study showed acupuncture to be a cost effective treatment”
NICE’s recommendations for a what should comprise a course of treatment were identical to our trial treatment course, that is, 10 sessions over a period of up to 12 weeks.
Thomas KJ, MacPherson H, Thorpe L, et al. Randomised controlled trial of a short course of traditional acupuncture compared to usual care for persistent low back pain. British Medical Journal, 2006; 333: 623-626.
Ratcliffe J, Thomas KJ, MacPherson H, Brazier J. A randomised controlled trial of acupuncture care for lower back pain: cost effectiveness analysis. British Medical Journal, 2006; 333: 626-628.
Hopton A, Thomas K, MacPherson H. The Acceptability of Acupuncture for Low Back Pain: A Qualitative Study of Patient’s Experiences Nested within a Randomised Controlled Trial. PLoS ONE. 2013; 8(2): e56806.[Full free text]
MacPherson H, Thomas K. Self-help advice as a process integral to traditional acupuncture care: implications for trial design. Complementary Therapies in Medicine. 2008; 16(2):101-6.
Bell-Syer SEM, Thorpe LN, Thomas K, MacPherson H. GP participation and recruitment of patients to RCTs: lessons from trials of acupuncture and exercise for low back pain in primary care. Evidence-based Complementary and Alternative Medicine, 2008.
Prady SL, Thomas K, Esmonde L, Crouch S, MacPherson H. The natural history of back pain after a randomised controlled trial of acupuncture vs usual care – long term outcomes. Acupuncture in Medicine 2007;25(4):121-129.
MacPherson H, Thomas K. Traditional acupuncture for low back pain: developing high quality evidence while maintaining the integrity of the intervention. European Journal of Oriental Medicine. 2007. 5(4): 26-30.
MacPherson H, Thomas KJ, Thorpe L. Beyond needling - therapeutic processes in acupuncture care: a qualitative study nested within low back pain trial. Journal of Alternative & Complementary Medicine, 2006; 12(9): 873-880.
Thomas KJ, MacPherson H, Thorpe L, Brazier J, Fitter M, Campbell M, Roman M, Walters S, Nicholl, J. Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain. Final report to NHS Health Technology Assessment Programme, 2005. [HTA Executive summary pdf] [Full HTA monograph pdf]
MacPherson H, Thorpe L, Thomas KJ, Campbell M. Acupuncture for low back pain: traditional diagnosis and treatment of 148 patients in a clinical trial. Complementary Therapies in Medicine. 2004; 12(1): 38-44.
MacPherson H, Gould AJ, Fitter M. Acupuncture for low back pain: results of a pilot study for a randomised controlled trial. Complementary Therapies in Medicine, 1999; 7(2): 83-90.
Thomas KJ, Fitter M, Brazier J, MacPherson H, Campbell M, Nicholl JP, Roman M. Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain assessed as suitable for primary care management. Complementary Therapies in Medicine, 1999; 7(2):91-100.
Fitter M, MacPherson H. An audit of case studies of low back pain: a feasibility study for a controlled trial. European Journal of Oriental Medicine. 1995; 1(5): 46-55.