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Radial Extracorporeal Shock Wave Therapy for Acute Hamstring Muscle Complex Injury Type 3b in Athletes

NCT03473899 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-23

No results posted yet for this study

Summary

This study tests the hypothesis that the combination of radial extracorporeal shock wave therapy performed with the Swiss DolorClast device (Electro Medical Systems, Nyon, Switzerland) and a specific rehabilitation program (hereafter, "rESWT + RP") is effective and safe in treatment of acute hamstring muscle complex injury Type 3b, and is statistically significantly more effective than the combination of sham-rESWT and RP (hereafter, "sham-rESWT + RP").

Conditions

  • Athletic Injuries

Interventions

DEVICE

rESWT

rESWT will be performed as follows: * Nine rESWT sessions * Three sessions per week * rESWT device: Swiss DolorClast (Electro Medical Systems, Nyon Switzerland), EvoBlue handpiece, 15 mm applicator * 2500 rESWs per session, with energy density between 0.12 and 0.16 mJ/mm\^2, depending on what the patient tolerates * rESWs applied at 15 Hz * Application of rESWs in prone position, with the patient lying on an examination table * Exact location of the application of rESWs determined by clinical and ultrasonographic examinations * Treatment of both the side of injury and the entire affected muscle (from distal to proximal in order to relax the affected muscle) * No use of local anesthesia. In addition, patients will receive a specific rehabilitation program.

DEVICE

Sham-rESWT

Sham-rESWT will be performed as rESWT described in Arm rESWT + RP, but with a specially designed placebo EvoBlue handpiece that looks and sounds like the EvoBlue handpiece of the Swiss DolorClast, but does not generate radial shock waves. This is achieved by blocking the projectile shortly before it strikes the metal applicator. The placebo EvoBlue handpiece will not emit any radial shock wave energy. In addition, patients will receive a specific rehabilitation program.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Kinef Kinesiología Deportiva

    lead OTHER

Principal Investigators

  • Javier Crupnik, PT · Kinef Kinesiología Deportiva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2020-03-21
Completion
2020-10-01

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473899 on ClinicalTrials.gov