Inefficacy of ultrasound-guided local injections of autologous conditioned plasma for recent epicondylitis: results of a double-blind placebo-controlled randomized clinical trial with one-year follow-up

Montalvan, Bernard; Goux, P. Le; Klouche, Shahnaz; Borgel, Delphine; Hardy, Philippe; Bréban, Maxime

doi:10.1093/rheumatology/kev326

Cited by 76 publications

(71 citation statements)

References 28 publications

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“…These results confirm previous network meta-analysis comparing PRP, autologous blood and CS [72]. However, PRP was not effective in patients with first episode epicondylopathy in a RCT [73].…”

Section: Tendinopathiessupporting

confidence: 89%

How far have biological therapies come in regenerative sports medicine?

Andı́a

Maffulli

2018

Expert Opinion on Biological Therapy

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Regular engagement in sports produces many health benefits, but also exposes to increased injury risk. The quality of medical care available is crucial not only for sports trauma but also to avoid overuse syndromes and post-traumatic degenerative conditions. Areas covered: We provide background information on some clinical needs in sport injuries and describe the main families of biological products used in clinical practice. We also discuss limitations of the current clinical experience. Expert opinion: Sport and exercise impairment affects different segments of the population with different needs. The exceptional demands of elite athletes and subsequent media coverage have created hype around regenerative therapies. Statistical evidence, whether weak (cell products) or moderate (PRPs), is not enough to drive medical decisions because of the heterogeneity of the biological products available and their application procedures. Moreover, the specific needs of the different segments of the population along with the available clinical evidence for each musculoskeletal condition should be considered in the decision-making process. There is urgent need to develop regenerative protocols combined with post-intervention rehabilitation, and gather meaningful clinical data on the safety and efficacy of these interventions in the different populations segments.

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Section: Tendinopathiessupporting

confidence: 89%

How far have biological therapies come in regenerative sports medicine?

Andı́a

Maffulli

2018

Expert Opinion on Biological Therapy

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“…There are conflicting results regarding the effectiveness of PRP in the literature. In the study conducted by Montalvan et al, 11 25 patients were assigned into two groups in which PRP were injected twice over a period of four weeks in the study group and normal saline was injected in the control group. Patients were evaluated for VAS on first, third, sixth, and 12 th months.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Effects of Leukocyte-Rich and Leukocyte-Poor Platelet-Rich Plasma on Pain and Functionality in Patients With Lateral Epicondylitis

Yerlikaya

2018

Arch Rheumatol

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“…In a similar blinded RCT involving 50 patients, Schö et al (15) found no clinical differences at 6 months of follow-up. Montalvan et al (16) found in a RCT involving 50 patients between 2 in ltrations of PRP and saline no clinical differences at 6 months of follow-up. Rehabilitation was not allowed during the trial and the tendon was not peppered.…”

Section: Introductionmentioning

confidence: 93%

Tennis Elbow, Study Protocol for Randomized Clinical Trial: Needling With and Without Platelet-Rich Plasma After Failure of Up-to-Date Rehabilitation

Schwitzguébel

Bogoev²,

Nikolov³

et al. 2020

Preprint

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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.This monocentric study including 232 patients will occur in two steps. During the first step, all patients will undergo an up-to-date rehabilitation, including epicondylar stretching and strengthening, periscapular tonification, epicondylar brace or taping, and focused extracorporeal shock waves therapy. Unsatisfied patients after the first step will be allocated for the 1:1 randomized trial of second step. Stratification is planned on age and lesion pattern. The masking will be quadruple (Participant, Care Provider, Investigator & Outcome Assessor). The patients will undergo ultrasound (US)-guided needling combined with either PRP (intervention group) or saline (Control group). Outcome data will be collected at -3, 0, 3, 6, and 12 months of the intervention.The primary endpoint is the pain improvement between months 0 and 3 on a 0-10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle. The secondary endpoints include the proportion of patients for which the tendon needling is not necessary after rehabilitation protocol, pain changes on VAS at rest and during maximal strength isometric contraction, changes of Single Assessment Numeric Evaluation (SANE) score, changes of Patient-Rated Tennis Elbow Evaluation (PRTEE) score, changes of maximal grip strength on Jamar test, and changes of the US of the epicondylar tendons (i.e. Volume of the lesion in mm3; Doppler reaction classified at the proportion of the tendon marked with the Doppler signal; Solution of continuity in mm3; Tendon thickness in mm; Concomitant superficial lesion & volume in mm3; Pain on a 0-10 VAS scale during sonopalpation).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

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Inefficacy of ultrasound-guided local injections of autologous conditioned plasma for recent epicondylitis: results of a double-blind placebo-controlled randomized clinical trial with one-year follow-up

Abstract: ClinicalTrials.gov; https://clinicaltrials.gov/; NCT02378285.

Cited by 76 publications

References 28 publications

How far have biological therapies come in regenerative sports medicine?

How far have biological therapies come in regenerative sports medicine?

Comparison of Effects of Leukocyte-Rich and Leukocyte-Poor Platelet-Rich Plasma on Pain and Functionality in Patients With Lateral Epicondylitis

Tennis Elbow, Study Protocol for Randomized Clinical Trial: Needling With and Without Platelet-Rich Plasma After Failure of Up-to-Date Rehabilitation

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