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BMC Musculoskeletal Disorders
Research article

BioMed Central

Open Access

Acupuncture for pain and osteoarthritis of the knee: a pilot study for an open parallel-arm randomised controlled trial
Harriet Lansdown1, Katie Howard1, Stephen Brealey1 and Hugh MacPherson*1,2
Address: 1Department of Health Sciences, University of York, York, UK and 2Foundation for Research into TraditionalChinese Medicine, York, UK Email: Harriet Lansdown - harrietlansdown@gmail.com; Katie Howard - katiedrawoh@hotmail.co.uk; Stephen Brealey - sb143@york.ac.uk; Hugh MacPherson* - hm18@york.ac.uk * Corresponding author

Published: 24 October 2009 BMC Musculoskeletal Disorders 2009, 10:130 doi:10.1186/1471-2474-10-130

Received: 19 February 2009 Accepted: 24 October 2009

This article is availablefrom: http://www.biomedcentral.com/1471-2474/10/130 © 2009 Lansdown et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

AbstractBackground: There is some evidence that acupuncture for pain and osteoarthritis (OA) of the knee is more than a placebo, and short term clinical benefits have been observed when acupuncture is compared to usual care. However there is insufficient evidence on whether clinical benefits of acupuncture are sustained over the longer term. In this study our key objectives are to inform the design parameters fora fully powered pragmatic randomised controlled trial. These objectives include establishing potential recruitment rates, appropriate validated outcome measures, attendance levels for acupuncture treatment, loss to follow up and the sample size for a full scale trial. Methods: Potential participants aged over 50 with pain and osteoarthritis of the knee were identified from a GP database. Eligiblepatients were randomised to either 'acupuncture plus usual care' and 'usual care' alone, with allocation appropriately concealed. Acupuncture consisted of up to 10 sessions usually weekly. Outcome measures included Western Ontario and McMaster Universities (WOMAC) index with the sample size for a full scale trial determined from the variance. Results: From the GP database of 15,927 patients, 335potential trial participants were identified and invited to participate. After screening responses, 78 (23%) were identified as eligible and 30 patients who responded most promptly were randomised to 'acupuncture plus usual care' (15 patients) and 'usual care' alone (15 patients). Attendance for acupuncture appointments was high at 90% of the maximum. Although the trial was not powered to detectsignificant changes in outcome, the WOMAC pain index showed a statistically significant reduction at 3 months in the acupuncture group compared to usual care. This was not sustained at 12 months. The sample size for a fully powered two-arm trial was estimated to be 350. Conclusion: This pilot study provided the evidence that a fully powered study to explore the longer term impact of acupuncturewould be worthwhile, and relevant design features for such a trial were determined. Trial registration number: ISRCTN25134802.

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(page number not for citation purposes)

BMC Musculoskeletal Disorders 2009, 10:130

http://www.biomedcentral.com/1471-2474/10/130

Background
Pain and osteoarthritis (OA) of the knee are accompanied with varying degrees of functional limitation andreduced quality of life[1] In adults aged 45 years and over, the most common site of peripheral joint pain is in the knee and the highest prevalence of knee pain is amongst women aged 75 and over[2] Established risk factors for knee OA include obesity, age, female gender, misalignment, and knee injury [3-5] Osteoarthritis of the knee is a serious and chronic condition. In an increasingly ageing...
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