Effect of NMES+ on Hamstring Lesion (3a/3b)

September 25, 2023 updated by: Università degli studi di Roma Foro Italico

Is Early Superimposed Neuromuscular Electrical Stimulation (NMES+) Useful to Improve Muscle Tissue Recovery From Type 3a/3b Hamstring Strain Injuries (HSI)?

The goal of this clinical trial is to analyze the effect of the electrical stimulation superimposed onto movement in healthy semi-professional athletes who sustained a type 3a/3b hamstring strain injury.

The main questions it aims to answer are:

  • Is NMES+ useful for the treatment of type 3a/3b hamstring strain injury?
  • Does NMES+ improve the quality of the injured muscle tissue? Participants will follow a 3 week protocol, following the latest evidence available.[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • recreational or semi-professional athletes
  • Body Mass Index between 18,5 e 24,9
  • Hamstring strain lesion type 3a/3b

Exclusion Criteria:

  • previous hamstring strain lesions
  • Anterior Cruciate Ligament Reconstruction using Hamstring graft
  • Current hamstring strains

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group

The Treatment Group will follow the rehabilitation protocol with the addition of the Neuromuscular Electrical Stimulation Superimposed onto Movement (NMES+) as part of the rehabilitation protocol.

1st/2nd Week at 35 Hertz. 3rd/4th Week 50 Hertz. 5th/6th Week 70 Hertz
Device: NMES+

The Treatment Group will follow the rehabilitation protocol with the addition of the NMES+.

1st/2nd Week at 35 Hertz. 3rd/4th Week 50 Hertz. 5th/6th Week 70 Hertz.

Procedure: Rehab

The Control Group will follow a protocol based on the latest available guidelines for the rehabilitation of the hamstrings lesions.

A weight-bearing protocol with a week by week progression on load, repetitions and sets.
Active Comparator: Control Group

The Control Group will follow the same rehabilitation protocol with no addition of the NMES+.

A weight-bearing protocol with a week by week progression on load, repetitions and sets.
Procedure: Rehab

The Control Group will follow a protocol based on the latest available guidelines for the rehabilitation of the hamstrings lesions.

A weight-bearing protocol with a week by week progression on load, repetitions and sets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear monitoring and muscle quality
Time Frame: Baseline
Healing status of the muscle tear (mm/cm), using ultrasounds
Baseline
Tear Monitoring
Time Frame: Up to 6 weeks
Healing status of the muscle tear (mm/cm), using ultrasounds
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli studi di Roma Foro Italico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMESHAMSTRING1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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