Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?: The "Acupuncture, Physiotherapy and Exercise" (APEX) study [ISRCTN88597683]

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Is acupuncture a useful adjunct to physiotherapy for older adults with knee pain?: The "Acupuncture, Physiotherapy and Exercise" (APEX) study [ISRCTN88597683]
Received: 10 August 2004
Accepted: 2 September 2004
Published: 2 September 2004
Elaine Hay1,2 , Panos Barlas1,3 , Nadine Foster1,3 , Jonathan Hill1 , Elaine Thomas1 and Julie Young1
BMC Musculoskeletal Disorders 2004
BioMed Central

1Primary Care Sciences Research Centre, Keele University, Keele, North Staffordshire, United Kingdom, ST5 5BG
2Staffordshire Rheumatology Centre, The Haywood, Burslem, Stoke-on-Trent, North Staffordshire, United Kingdom, ST6 7AG
3School of Health & Rehabilitation, Keele University, Keele, North Staffordshire, United Kingdom, ST5 5BG

Abstract

Background
Acupuncture is a popular non-pharmacological modality for treating musculoskeletal pain. Physiotherapists are one of the largest groups of acupuncture providers within the NHS, and they commonly use it alongside advice and exercise. Conclusive evidence of acupuncture's clinical effectiveness and its superiority over sham interventions is lacking. The Arthritis Research Campaign (arc) has funded this randomised sham-controlled trial which addresses three important questions. Firstly, we will determine the additional benefit of true acupuncture when used by physiotherapists alongside advice and exercise for older people presenting to primary care with knee pain. Secondly, we will evaluate sham acupuncture in the same way. Thirdly, we will investigate the treatment preferences and expectations of both the participants and physiotherapists participating in the study, and explore the effect of these on clinical outcome. We will thus investigate whether acupuncture is a useful adjunct to advice and exercise for treating knee pain and gain insight into whether this effect is due to specific needling properties.

Methods/Design
This randomised clinical trial will recruit 350 participants with knee pain to three intervention arms. It is based in 43 community physiotherapy departments in 21 NHS Trusts in the West Midlands and Cheshire regions in England. Patients aged 50 years and over with knee pain will be recruited. Outcome data will be collected by self-complete questionnaires before randomisation, and 6 weeks, 6 months and 12 months after randomisation and by telephone interview 2 weeks after treatment commences. The questionnaires collect demographic details as well as information on knee-related pain, movement and function, pain intensity and affect, main functional problem, illness perceptions, self-efficacy, treatment preference and expectations, general health and quality of life. Participants are randomised to receive a package of advice and exercise; or this package plus real acupuncture; or this package plus sham acupuncture. Treatment details are being collected on a standard proforma. Interventions are delivered by experienced physiotherapists who have all received training in acupuncture to recognised national standards. The primary analysis will investigate the main treatment effects of real or sham acupuncture as an adjunct to advice and exercise.

Discussion
This paper presents detail on the rationale, design, methods, and operational aspects of the trial.

Background
Knee pain in older adults is a common disabling problem. Approximately 25% of the population aged over 55 years are affected at any one time and half of these will have some restriction of normal daily activities [1,2]. After excluding `red flags' and specific pathologies such as inflammatory arthritis, most knee pain in older adults is due to osteoarthritis. Controlling the pain and minimising loss of function are the principal aims of treatment. Most sufferers are managed exclusively in primary care [3-5], where the usual approaches include analgesics and exercise [6-11]. A report from Arthritis Care [12] of patients' perspectives highlighted that people with knee osteoarthritis want treatment offering more pain relief and help with mobility. Easy to understand information was also felt to be important, as was exercise, to help manage the problem. A recent review of international guidelines suggests that, for patients with knee pain, the best non-pharmacological care consists of education, muscle strengthening and exercise [13].

Patients with musculoskeletal pain often choose methods of treatment that are not widely available within the NHS, such as complementary medicine [14]. Reports from the United States and the United Kingdom have indicated the popularity of complementary medicine with the general public and health care professionals [15-19]. Complementary medicine is available in approximately 40% of general practice surgeries and general practitioners and physiotherapists are the largest providers of complementary medicine within the NHS [17]. Acupuncture is one of the most popular complementary medicine modalities in the UK: reports suggest that it is available in 84% of chronic pain clinics and approximately 4000 general practitioners and physiotherapists are trained in acupuncture [21,22]. Although recent authors have promoted the concept of integrated practice incorporating conventional and complementary therapies [20], current guidelines highlight the need for further research evidence for the use of acupuncture for knee pain in older adults [13]. The clinical effectiveness of acupuncture, and the question of whether it is superior to sham interventions has not been established. In addition to providing exercise and advice, physiotherapists are also one of the largest groups of acupuncture providers within both primary and secondary care in the NHS [23]. Physiotherapy is therefore an appropriate and important arena in which to investigate the effectiveness of integrated mainstream and complementary therapy.

© 2004 Hay et al; licensee BioMed Central Ltd.
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