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

Not Applicable

Not yet recruiting

• Conditions: Muscle Rupture; Hamstring Sprain; Hamstring Injury
• Interventions: Device: NMES+; Procedure: Rehab

• Registration Number: NCT05786300
• Lead Sponsor: Università degli studi di Roma Foro Italico

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 \[insert effects\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-03-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26
• Study Start: 2023-11-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Rehab	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
Treatment Group	NMES+	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
Control Group	Rehab	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.

Primary Outcome Measures

Name	Time	Method
Tear monitoring and muscle quality	Baseline	Healing status of the muscle tear (mm/cm), using ultrasounds
Tear Monitoring	Up to 6 weeks	Healing status of the muscle tear (mm/cm), using ultrasounds