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

NCT03473899 | Unknown

• 1 other identifier: CrupnikDolorClastMuscleInjury
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Individual time (days) necessary to return to play.

  Individual treatment success is defined as the possibility to return to play, fulfilling all criteria specified by Van de Horst et al. (Sports Med 2016;46(6):899-912). Accodingly, the primary outcome measure is the number of days until "yes" (return to play possible according to the criteria established by Van de Horst et al., 2016) will be achieved.

  From date of randomization until the date of return to play, up to six months

Secondary Outcomes (2)

• Individual patient's satisfaction

  Six months after randomization

• Presence or absence of re-injury

  From date of randomization up to six months

Study Arms (2)

rESWT + RP

ACTIVE COMPARATOR

Device: rESWT

Device: rESWT

sham-rESWT + RP

PLACEBO COMPARATOR

Device: sham-rESWT

Device: Sham-rESWT

Interventions

rESWT DEVICE

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.

rESWT + RP

Sham-rESWT DEVICE

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.

sham-rESWT + RP

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (both male and female) with clinical and ultrasonographic diagnosis of acute HMC injury Type 3b
• Age range: between 18 and 35 years
• Physical conditions for rehabilitation (i.e., no surgery required)
• Willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient
• No contraindications for rESWT

You may not qualify if:

• Children and teenagers below the age of 18
• Adults aged \>35 years old
• Patients with clinical and ultrasonographic diagnosis of acute HMC injury Type 3b who got injured more than seven days before potential enrollment into this study
• Patients with clinical and ultrasonographic diagnosis of acute HMC injury Type 3A or Type 4
• Bilateral acute HMC injury (Types 3A, 3B or 4)
• Proven or suspected HMC injury (Types 3A, 3B or 4) of the same lower limb in the time period of six months before potential enrollment into this study
• Muscle injury caused by external impact on the back of the affected thigh
• Surgery on the affected lower limb in the time period of one year before potential enrollment into this study
• Acute or chronic lumbar pathology (because some cases of thigh pain may relate to spinal pathology)
• No willingness of the patient to participate in this study, and/or written informed consent not signed and not personally dated by the patient
• Contraindications of rESWT, i.e., treatment of pregnant patients, treatment of patients with blood-clotting disorders (including local thrombosis), treatment of patients treated with oral anticoagulants, treatment of patients with local bacterial and/or viral infections/inflammations, treatment of patients with local tumors, and treatment of patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session (if applicable).

Sponsors & Collaborators

• Kinef Kinesiología Deportiva: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

KinEf Kinesiología Deportiva

Buenos Aires, Buenos Aires F.D., 1426, Argentina

RECRUITING

Related Publications (1)

• Crupnik J, Silveti S, Wajnstein N, Rolon A, Vollhardt A, Stiller P, Schmitz C. 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. J Orthop Surg Res. 2019 Jul 23;14(1):234. doi: 10.1186/s13018-019-1283-x.

  PMID: 31337441 DERIVED

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Javier Crupnik, PT

  Kinef Kinesiología Deportiva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Crupnik, PT

CONTACT

+54-911-51483899; jcrupnik@ondasdechoque.com.ar

Santiago Silveti, PT

CONTACT

+54-9-341-3998899; santiagosilveti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A medical assistant at the clinic of the Principal Investigator will allocate interventions by means of opaque sealed envelopes that will be marked according to the allocation schedule. The medical assistant will be unaware of the size of the blocks. The randomized intervention assignment as outlined above will be concealed from both patients and health care staff until recruitment will be complete and irrevocable. Patients will be blinded in this study. The assessor will be blinded in this study. The assessor is the person who will assess the outcome of treatment during follow up. In this study, the assessor will be a medical assistant at the clinic of the Principal Investigator. The therapist will not be blinded in this study. The therapist is the person who will administer either rESWT or sham-rESWT to the patient. In this study, the therapist will be the Principal Investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: March 22, 2018
• Study Start: March 22, 2018
• Primary Completion: March 21, 2020
• Study Completion: October 1, 2020
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)