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In adults with painful midportion Achilles tendinopathy lasting longer than 3 months, does a single injection of platelet-rich plasma result in better function when compared with a sham injection 6 months after treatment?
This randomized clinical trial included 240 participants with pain at the midportion of the Achilles tendon. Treatment with a single injection of intratendinous platelet-rich plasma vs a subcutaneous dry needle resulted in a mean Victorian Institute of Sport Assessment-Achilles score at 6 months of 54.4 vs 53.4 (range, 0 [worst symptoms] to 100 [no symptoms]); this difference was not statistically significant.
A single injection of platelet-rich plasma compared with a sham injection did not significantly reduce Achilles tendon dysfunction.
Platelet-rich plasma injections are used as a treatment for chronic midportion Achilles tendinopathy, but evidence for this treatment is limited.
In adults with midportion Achilles tendinopathy, to assess the effects of a single platelet-rich plasma injection, compared with sham injection, on the outcome of the Victorian Institute of Sport Assessment-Achilles (VISA-A) score (a single composite measure of Achilles tendinopathy severity).
Design, Setting, and Participants
A participant-blinded, multicenter randomized clinical trial that included 240 people from 24 sites assigned to either a platelet-rich plasma injection or a sham injection between April 2016 and February 2020. Final follow-up was July 2020. Participants were older than 18 years with midportion Achilles tendon pain for more than 3 months as confirmed by ultrasound, magnetic resonance imaging, or both.
A single intratendinous platelet-rich plasma injection (n = 121) or a single sham injection (insertion of a subcutaneous dry needle not entering the tendon) (n = 119).
Main Outcomes and Measures
The primary outcome was the VISA-A score, measured 6 months after treatment allocation. The VISA-A score contains 8 questions that cover 3 domains of pain, function, and activity, analyzed as a composite score (range, 0 [worst symptoms] to 100 [no symptoms]; minimal clinically important difference in score, 12 points). The primary analysis was adjusted for laterality, age, sex, and baseline VISA-A score.
Among 240 patients assigned to a platelet-rich plasma or sham injection (mean age, 52 years; 138 [58%] women), 221 (92%) completed the trial. At 6-month follow-up, mean VISA-A score values in the plasma-rich plasma group vs the sham injection group were 54.4 vs 53.4 (adjusted mean difference, −2.7 [95% CI, −8.8 to 3.3]). The most common adverse events compared between patients in the platelet-rich plasma group vs the sham group were injection site discomfort (97 vs 73 patients), swelling (56 vs 52 patients) and bruising (48 vs 49 patients).
Conclusions and Relevance
Among patients with chronic midportion Achilles tendinopathy, treatment with a single injection of intratendinous platelet-rich plasma, compared with insertion of a subcutaneous dry needle, did not reduce Achilles tendon dysfunction at 6 months. These findings do not support the use of this treatment for chronic midportion Achilles tendinopathy.
isrctn.org Identifier: ISRCTN13254422
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Corresponding Author: Rebecca S. Kearney, PhD, Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, United Kingdom (email@example.com).
Accepted for Publication: April 19, 2021.
Author Contributions: Dr Kearney had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Kearney, Warwick, Parsons, Brown, Harrison, Young, Costa.
Acquisition, analysis, or interpretation of data: Kearney, Ji, Warwick, Parsons, Harrison, Costa.
Drafting of the manuscript: Kearney, Warwick, Parsons, Harrison, Young.
Critical revision of the manuscript for important intellectual content: Kearney, Ji, Warwick, Parsons, Brown, Costa.
Statistical analysis: Ji, Warwick, Parsons.
Obtained funding: Kearney, Parsons, Young, Costa.
Administrative, technical, or material support: Kearney, Parsons, Brown, Harrison, Costa.
Supervision: Kearney, Warwick.
Conflict of Interest Disclosures: Dr Kearney reported grants from Versus Arthritis during the conduct of the study and research grant funding from her institution (University of Warwick, which receives research funding from the UK National Institute for Health Research [NIHR], the National Health and Medical Research Council [NHMRC], Versus Arthritis, and orthopedic industry) outside the submitted work; and being coinvestigator on an NIHR-funded study receiving additional support from Stryker. Dr Ji reported grants from Versus Arthritis during the conduct of the study. Dr Warwick reported receiving grants from NIHR. Dr Parsons reported grants from Versus Arthritis during the conduct of the study. Dr Harrison reported funding by NIHR, Surgical Reconstruction and Microbiology Research Centre (SRMRC), and support from the Centre for Conflict Wound Research (which is funded by the Scar Free Foundation through a grant from the chancellor using London Interbank Offered Rate [LIBOR] funds. Dr Costa reported grants from his institution (University of Oxford, which receives research grant funding from the UK NIHR, the European Union, NHMRC, Versus Arthritis, Heraeus Medical GmbH, and SOTA Orthopaedics) outside the submitted work. No other disclosures were reported.
Funding/Support: This trial was funded by Versus Arthritis commencing on September 1, 2015 (Versus Arthritis 20831).
Role of the Funder/Sponsor: Versus Arthritis and the University of Warwick had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The views expressed are those of the author(s) and not necessarily those of the Versus Arthritis.
Group Information: The ATM Trial Collaborators appear in Supplement 4.
Data Sharing Statement: See Supplement 5.
Additional Contributions: We would like to thank all the patients and the research support at each recruitment centre that made the trial a success. The research team would also like to acknowledge Karen Keates, the patient and public involvement representative; Philip Moss (University of Warwick), data collection; Martin Underwood, MD (University of Warwick), interim maternity cover chief investigator; and the trial steering committee and data monitoring and ethics committee for their contribution throughout the feasibility and main trial. These roles were supported through the Versus Arthritis research grant.
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