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Platelet rich plasma versus placebo for the management of achilles tendinopathy : protocol for the UK study of achilles tendinopathy management (ATM) multi-centre randomised trial
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Kearney, Rebecca S., Parsons, Nicholas R., Ji, Chen, Warwick, Jane, Brown, Jaclyn, Young, Jonathan and Costa, Matthew L. (2020) Platelet rich plasma versus placebo for the management of achilles tendinopathy : protocol for the UK study of achilles tendinopathy management (ATM) multi-centre randomised trial. BMJ Open, 10 (2). e034076. doi:10.1136/bmjopen-2019-034076 ISSN 2044-6055.
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Official URL: http://dx.doi. org/10.1136/bmjopen-2019- 034076
Abstract
Introduction In the UK, 150 000 people every year experience mid-substance Achilles tendinopathy. Typically patients are offered a range of treatment options such as exercise, electrotherapy, injections and surgery. With large variations in current practice, there is a pressing need to establish which treatments are effective and which are not. This is the protocol for a multi-centre randomised trial of platelet rich plasma (PRP) versus placebo injection for patients with Achilles tendinopathy.
Methods and analysis Adult patients with mid-substance Achilles tendinopathy for longer than 3 months will be screened. Randomisation will be on a 1:1 basis, stratified by centre and bilateral presentation. Participants will be allocated to either a single PRP injection or placebo injection. A minimum of 240 patients will be recruited into the study; this number will provide 90% power to detect a difference of 12 points in Victorian Institute of Sport Assessment-Achilles score at 6 months. Quality of life, pain and complications data will be collected at baseline, 2-week, 3-month and 6-month post-randomisation. The differences between treatment groups will be assessed on an intention-to-treat basis.
Ethics, registration and dissemination This trial was funded by Versus Arthritis and commenced on 1 September 2015 (Versus Arthritis 20831). National Research Ethic Committee approved this study on 30 October 2015 (15/WM/0359). It was registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry with reference number ISRCTN 13254422 on 28 October 2015. The first site opened to recruitment on 27 April 2016 and the trial was in active recruitment at the point of submitting the protocol paper. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice with regard to the treatment of Achilles tendinopathy.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RD Surgery R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit 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): | Achilles tendon -- Wounds and injuries -- Treatment, Tendons -- Wounds and injuries, Blood platelets -- Transfusion, Placebos (Medicine) | ||||||
| Journal or Publication Title: | BMJ Open | ||||||
| Publisher: | BMJ | ||||||
| ISSN: | 2044-6055 | ||||||
| Official Date: | 12 February 2020 | ||||||
| Dates: |
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| Volume: | 10 | ||||||
| Number: | 2 | ||||||
| Article Number: | e034076 | ||||||
| DOI: | 10.1136/bmjopen-2019-034076 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Copyright Holders: | © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. | ||||||
| Date of first compliant deposit: | 4 February 2020 | ||||||
| Date of first compliant Open Access: | 10 September 2020 | ||||||
| RIOXX Funder/Project Grant: |
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