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Physiotherapy rehabilitation for osteoporotic vertebral fracture (PROVE) : study protocol for a randomised controlled trial
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Barker, Karen, MSc, Javaid, Muhammad K., Newman, Meredith, Lowe, Catherine Minns, Stallard, Nigel, Campbell, Helen, Gandhi, Varsha and Lamb, S. E. (Sallie E.) (2014) Physiotherapy rehabilitation for osteoporotic vertebral fracture (PROVE) : study protocol for a randomised controlled trial. Trials, Volume 15 (Number 1). Article Number 22. doi:10.1186/1745-6215-15-22 ISSN 1745-6215.
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WRAP_Stallard_1745-6215-15-22.pdf - Published Version Available under License Creative Commons Attribution 2.0.. Download (569Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/1745-6215-15-22
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.
Item Type: | Journal Article | ||||
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Subjects: | R Medicine > R Medicine (General) | ||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Osteoporosis -- Great Britain, Physical therapy -- Great Britain, Fractures -- Treatment -- Great Britain , Clinical trials -- Great Britain | ||||
Journal or Publication Title: | Trials | ||||
Publisher: | Biomed Central | ||||
ISSN: | 1745-6215 | ||||
Official Date: | 2014 | ||||
Dates: |
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Volume: | Volume 15 | ||||
Number: | Number 1 | ||||
Article Number: | Article Number 22 | ||||
DOI: | 10.1186/1745-6215-15-22 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Open Access (Creative Commons) | ||||
Date of first compliant deposit: | 26 December 2015 | ||||
Date of first compliant Open Access: | 26 December 2015 | ||||
Funder: | National Institute for Health Research (Great Britain) (NIHR) | ||||
Grant number: | HTA 10/99/01 (NIHR) |
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