McVeigh 2006: FMS exercise RCT exercise-no difference. Publicatn bias -only abstract?

Dolphin

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Forgive me for being cynical but I have to wonder whether this randomised controlled trial would have been published as a full paper rather than just as a poster and an abstract, if they had got results that suggested a combined pool-based exercise and education programme helped

(it was listed at: http://www.controlled-trials.com/ISRCTN21694164 - the third publication might look like a full paper but it's actually "Rehabilitation and Therapy Research Society Second Annual Conference The Challenges of Clinical Research: 25-26 May 2006 at University College Dublin" pp. 205-228(24) i.e. a review on the whole conference. It has been relatively buried.)

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McVeigh, J.G., Hurley, D.A., Basford, J.R., Sim, J., Baxter, G.D., Finch, M.B. (2006) 'Effectiveness of a combined pool-based exercise and education programme compared to usual care in fibromyalgia syndrome: a randomised controlled trial.

(Abstract)' Annals of the Rheumatic Diseases 65 (Suppl II) :557-557.

Effectiveness of a combined pool-based exercise and education programme compared to usual medical care in fibromyalgia syndrome: a randomised, controlled trial

J.G. McVeigh1, D.A. Hurley2, J.R. Basford3, J. Sim4, D. Baxter5 and M.B.Finch6

1Health and Rehabilitation Sciences Research Institute, University of Ulster, Belfast, UK 2School of Physiotherapy and Performance Science, University College Dublin, Dublin, Ireland 3Department of Physical Medicine and Rehabilitation, Mayo Clinic College of Medicine, Minnesota, USA 4Primary Care Sciences Research Centre, Keele University, Staffordshire, UK 5New Zealand Centre for Physiotherapy Research, University of Otago, Otago, New Zealand 6Department of Rehabilitation Medicine, Royal Hospitals Trust, Belfast, UK


Fibromyalgia syndrome (FMS) is a chronic muscular pain syndrome, whose optimal management remains problematic.1 The aim of this work was to determine the effectiveness of a 6-week combined pool-based exercise and education programme plus usual medical care versus usual medical care in the treatment of FMS.

Following ethical approval, a sample of convenience of 86 women (mean [SD] age 49.6 years [8.4]) with FMS were recruited. Participants were randomly allocated to 'usual medical care' (n = 44) or a 6-week pool-based exercise and education programme (n = 42).

Outcome measures included: the fibromyalgia impact questionnaire (FIQ), tender point count, total myalgic score, the euroqol health status questionnaire, the McGill pain questionnaire, the arthritis impact measurement scales 2 (AIMS2), the self-efficacy for managing chronic disease 6- item scale and the 6-min walk test.

Participants were assessed at baseline and at approximately 8 weeks (52/86, 60%), 20 weeks (44/86, 51%). Data were collected by the same researcher at each time point.

Attrition rates were similar for both groups. Between-group comparisons were performed with repeated measures analysis of covariance. Only a per protocol analysis is presented, protocol adherence for the intervention group (set at 50% of the intervention) was 71.4%.

Both groups were similar at baseline. At 8 weeks, mean (SD) FIQ scores were 76.0 (17.5) for the intervention group and 74.0 (20.3) for the usual care group. At 20 weeks, the corresponding values were 73.8 (23.5) and 76.8 (20.9). Repeated measures ANCOVA found no significant difference between groups across these time points for any outcome measure.

On the basis of per protocol analyses conducted at 20-week follow-up, the addition of a brief pool-based exercise and patient education programme to usual care does not offer superior benefit. The level of attrition in this study, however, limits more definitive conclusion from the current results.

Acknowledgement
Financial support was from a Chartered Society of Physiotherapy Research Foundation Project Grant, Fibromyalgia Support Group Northern Ireland.

Reference

1 Sim J, Adams N. Systematic review of randomised controlled trials of nonpharmacological interventions for fibromyalgia. Clin J Pain 2002;18:324-36