Tennis Elbow, study protocol for a randomized clinical trial: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation

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 20 August 2019

Comparison of conventional versus single port laparoscopy for surgical treatment of gynecological diseases: a pilot study.

“…The VAS score ranged from 0 to 10, which indicated no pain at 0 points, tolerable mild pain at 0-3 points, pain affecting sleep at 4-6 points, and severe pain affecting appetite at 7-10 points [17].…”

Effectiveness of a Single High Dose of Platelet-Rich Plasma (PRP) Injection Over Corticosteroid and Hyaluronic Acid Injections on Osteoarthritis, Chronic Tendinitis and Tennis Elbow Treatment

“…Biological components have been recently studied for KOA, CT and TE treatment such as MSCs and PRP. PRP is as autologous blood product enriched in platelets concentration [25] [26] [27]. Platelets are the natural healing cells recruited into the tissue injury [28]; in addition PRPs include antibacterial and fungicidal proteins, numerous growth factors (GFs) such as platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), insulin-like growth factor-I (IGF-I), fibroblastic growth factor (FGF) and hepatocyte growth factor (HGF) [29] [30].…”