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 Schwitzguebel,M Bogoev,A Lädermann,V Nikolov,F Ichane

doi:10.1186/s13018-020-01998-8

Abstract

BackgroundThe 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT03987256. Registered on 20 August 2019.

Highlights

The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition
The first aim of this study is to determine the proportion of patients that would need an infiltrative technique after a proper rehabilitation protocol including physical therapies, focused extracorporeal shock wave therapy (ESWT), and orthotics and Kinesio taping for all patients
1) The clinical efficacy of platelet-rich plasma as adjuvant therapy to tendon needling for patients suffering of epicondylar tendinosis managed with a first line up-to-date rehabilitation

Summary

Introduction

A treatment with platelet-rich plasma (PRP) is often performed, but its efficacy remains controversial. The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. The first-line conservative management includes physical therapies, orthotics [1], and extracorporeal shock wave therapy (ESWT) [2]. The success rate of ESWT for lateral epicondylitis depends mainly on the protocol that is followed. Focused ESWT has been showed to be as effective as surgical tenotomy [4]. Infiltrative therapies might be proposed in case of persistent symptoms. Prolotherapy, autologous blood or botulinic toxin injections, and others infiltrative therapies are less studied and are not clearly supported by the current literature [8,9,10]. Stem cells might be an appropriate alternative in the future [11]

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