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

NCT05786300 | Unknown FDA Device

• 1 other identifier: NMESHAMSTRING1
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 \[insert effects\].

Conditions

Hamstring Injury; Muscle Rupture; Hamstring Sprain

Keywords

Electrical Muscle Stimulation (EMS); NMES+; Hamstring strain injury; Neuromuscular Electrical Stimulation (NMES)

Outcome Measures

Primary Outcomes (2)

• Tear monitoring and muscle quality

  Healing status of the muscle tear (mm/cm), using ultrasounds

  Baseline

• Tear Monitoring

  Healing status of the muscle tear (mm/cm), using ultrasounds

  Up to 6 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

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+; Procedure: Rehab

Control Group

ACTIVE COMPARATOR

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

Interventions

NMES+ DEVICE

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.

Treatment Group

Rehab PROCEDURE

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.

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli studi di Roma Foro Italico: lead

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 27, 2023
• Study Start: November 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09