Evidence map›Paper›PMID 31337441›Full record

ArticleJournal of orthopaedic surgery and research2019

Is radial extracorporeal shock wave therapy combined with a specific rehabilitation program (rESWT + RP) more effective than sham-rESWT + RP for acute hamstring muscle complex injury type 3b in athletes? Study protocol for a prospective, randomized, double-blind, sham-controlled single centre trial.

Javier Crupnik, Santiago Silveti, Natalia Wajnstein, Alejandro Rolon, Alisa Vollhardt, Peter Stiller, Christoph Schmitz

Registry-linked trialOpen access · goldAbstract readComparative StudyClinical Trial Protocol
In one paragraph

Article in Journal of orthopaedic surgery and research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03473899 (A Prospective, Randomized, Double-blind, Placebo Controlled Single Centre Trial to Assess the Efficacy and Safety of rESWT Combined With a Specific Rehabilitation Program for Acute Hamstring Muscle Complex Injury Type 3b in Athletes), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.1field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03473899 naunknown statusnot on this map

A Prospective, Randomized, Double-blind, Placebo Controlled Single Centre Trial to Assess the Efficacy and Safety of rESWT Combined With a Specific Rehabilitation Program for Acute Hamstring Muscle Complex Injury Type 3b in Athletes

TypeinterventionalSponsorKinef Kinesiología DeportivaRan2018 to 2020Enrolled40ConditionsAthletic InjuriesArmsrESWT, Sham-rESWT
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Javier CrupnikKinEf Kinesiología Deportiva, Buenos Aires, Argentina.
Santiago SilvetiKinEf Kinesiología Deportiva, Buenos Aires, Argentina.
Natalia WajnsteinKinEf Kinesiología Deportiva, Buenos Aires, Argentina.
Alejandro RolonIMAXE Diagnostico X Imagenes, Buenos Aires, Argentina.
Alisa VollhardtExtracorporeal Shock Wave Research Unit, Chair of Neuroanatomy, Institute of Anatomy, Faculty of Medicine, LMU Munich, 80336, Munich, Germany.
Peter StillerDepartment of General Medicine, Clinic Lechhausen, Augsburg, Germany.
Christoph SchmitzExtracorporeal Shock Wave Research Unit, Chair of Neuroanatomy, Institute of Anatomy, Faculty of Medicine, LMU Munich, 80336, Munich, Germany. christoph_schmitz@med.uni-muenchen.de.ORCID http://orcid.org/0000-0002-4065-1241
LMU Klinikum · DELudwig-Maximilians-Universität München · DEUniversity Hospital Augsburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute injuries of the hamstring muscle complex (HMC) type 3b (interfascicle/bundle-tear) are frequently observed in various sports disciplines both in elite and recreational sport. The treatment of choice of acute HMC injuries type 3b is a progressive physiotherapeutic exercise programme. Besides this, there is currently only insufficient scientific evidence to support other treatment methods, including local infiltrations and injections of platelet-rich-plasma. Very recently, it was demonstrated that extracorporeal shock wave therapy (ESWT) may accelerate regeneration after acute skeletal muscle injury. The aim of the present study is to test the hypothesis that the combination of radial ESWT (rESWT) and a specific rehabilitation program (RP) is effective and safe in treatment of acute HMC injury type 3b in athletes, and is statistically significantly more effective than the combination of sham-rESWT and RP.

methodsWe will perform a double blind, randomized, sham-controlled clinical trial at the clinic KinEf Kinesiología Deportiva, Ciudad Autónoma de Buenos Aires, Argentina. Forty patients with acute HMC injury type 3b will be randomly allocated to receive either rESWT (nine rESWT sessions; three sessions per week; 2500 radial extracorporeal shock waves (rESWs) per session; energy density depending on what the patient tolerates) or sham-rESWT. In addition, all patients will receive a specific rehabilitation program that will last for 8 weeks. The primary outcome measure will be the individual time (days) necessary to return to play. Secondary outcomes will include the presence or absence of reinjury during a time period of 6 months after inclusion into the study. DISCUSSION: Because of the lack of adequate treatment options for acute HMC injury type 3b in athletes and particularly the high reinjury rate, we hypothesize that the results of this trial will be of importance and have impact on clinical practice.

trial registrationClinicalTrials.gov ID NCT03473899 . Registered March 22, 2018.

Indexed as

AthletesAdolescentAdultAthletic InjuriesCombined Modality TherapyDouble-Blind MethodExtracorporeal Shockwave TherapyFemaleFollow-Up StudiesHamstring MusclesHumansMalePlacebosProspective StudiesRandomized Controlled Trials as TopicSoft Tissue InjuriesPlacebosAcute hamstring muscle complex injury 3bAthletesESWTRadial extracorporeal shock wave therapyRehabilitationrESWT

Identifiers

PMID31337441
PMCPMC6651966
OpenAlexW2943965210

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.