Tennis elbow, study protocol for a randomized clinical trial: needling with and without platelet-rich plasma after failu
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(2020) 15:462
STUDY PROTOCOL
Open Access
Tennis elbow, study protocol for a randomized clinical trial: needling with and without platelet-rich plasma after failure of up-to-date rehabilitation A. J. Schwitzguebel1* , M. Bogoev2, V. Nikolov2, F. Ichane3 and A. Lädermann4,5,6
Abstract Background: The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. A treatment with platelet-rich plasma (PRP) is often performed, but its efficacy remains controversial. Methods: This study is a single-center, randomized double-blind controlled trial, preceded by a case series. All the 232 planned patients of the case series will undergo an up-to-date comprehensive rehabilitation program, including focused extracorporeal shock waves therapy. This rehabilitation program is expected to have a maximum success rate 75%. It is therefore aimed to allocate a minimum of 58 patients with rehabilitation failure into the 1:1 randomized trial. Stratification is planned on age and lesion pattern. The masking will be quadruple (Participant, Care Provider, Investigator & Outcome Assessor). The patients will undergo an ultrasound (US)-guided needling combined with either PRP (intervention group) or saline (control group). The primary endpoint will be the pain improvement from baseline (month 0) at 3 months on a 0–10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle. The main secondary endpoints will include the rehabilitation success rate and improvements from baseline at 3, 6, and 12 months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons. Discussion: The study results will provide insight into the effect of PRP as adjuvant therapy to tendon fenestration, and may contribute to identify the best preceding and concomitant rehabilitation protocol. Trial registration: ClinicalTrials.gov NCT03987256. Registered on 20 August 2019. Keywords: Clinical protocols, Double-blind method, Randomized, Research design, Tennis Elbow, Tendinopathy, Rehabilitation, Extracorporeal shock waves therapy, Platelet-rich plasma, Ultrasonography, Interventional
* Correspondence: [email protected] 1 Sports Medicine Division, La Providence Hospital, Fbg de l’Hopital 81, 2000 Neuchâtel, Switzerland Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative C
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