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NCT05786300 Clinical Trial

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

Hamstring Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05786300
Other study ID # NMESHAMSTRING1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date December 1, 2024

Study information
Verified date September 2023
Source Università degli studi di Roma Foro Italico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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].

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Università degli studi di Roma Foro Italico

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