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Open Access Study protocol

Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

Karen L Barker12*, Muhammad K Javaid1, Meredith Newman2, Catherine Minns Lowe2, Nigel Stallard3, Helen Campbell4, Varsha Gandhi1 and Sallie Lamb1

Author Affiliations

1 NIHR – BRU, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK

2 Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust, Windmill Road, Oxford OX3 7HE, UK

3 Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

4 Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford OX3 7LF, UK

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Trials 2014, 15:22  doi:10.1186/1745-6215-15-22

Published: 14 January 2014

Abstract

Background

Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care.

Methods/Design

Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year.

Discussion

There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown.

Trial registration

Reference number ISRCTN49117867.

Keywords:
Randomised controlled trial; Osteoporosis; Rehabilitation; Vertebral fracture