NDLI: Tennis elbow, study protocol for a randomized clinical trial: needling with and without platelet-rich plasma after failure of up-to-date rehabilitation

Content Provider	Springer Nature : BioMed Central
Author	Schwitzguebel, A. J. Bogoev, M. Nikolov, V. Ichane, F. Lädermann, A.
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.
Related Links	https://josr-online.biomedcentral.com/counter/pdf/10.1186/s13018-020-01998-8.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
DOI	10.1186/s13018-020-01998-8
Journal	Journal of Orthopaedic Surgery and Research
Issue Number	1
Volume Number	15
Language	English
Publisher	BioMed Central
Publisher Date	2020-10-07
Access Restriction	Open
Subject Keyword	Orthopedics Surgical Orthopedics Clinical protocols Double-blind method Randomized Research design Tennis Elbow Tendinopathy Rehabilitation Extracorporeal shock waves therapy Platelet-rich plasma Ultrasonography Interventional
Content Type	Text
Resource Type	Article
Subject	Surgery Orthopedics and Sports Medicine
Journal Impact Factor	2.8/2023
5-Year Journal Impact Factor	3/2023

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