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Not yet recruitingNCT05786300Updated Sep 26, 2023

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

An interventional study of NMES+ and Rehab in Hamstring Injury, Muscle Rupture and Hamstring Sprain, sponsored by Università degli studi di Roma Foro Italico. Not yet recruiting. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Università degli studi di Roma Foro Italico · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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].
02

Conditions studied

  • Hamstring Injury
  • Muscle Rupture
  • Hamstring Sprain

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Keywords

  • Electrical Muscle Stimulation (EMS)
  • NMES+
  • Hamstring strain injury
  • Neuromuscular Electrical Stimulation (NMES)
03

In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 334 interventional studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Università degli studi di Roma Foro Italico is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • previous hamstring strain lesions
  • Anterior Cruciate Ligament Reconstruction using Hamstring graft
  • Current hamstring strains
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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+ · Procedure: Rehab

  • 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

Interventions

  • DeviceNMES+

    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.

  • ProcedureRehab

    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.

06

What researchers measure

Primary outcomes

  1. Tear monitoring and muscle quality

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

    Time frame: Baseline

  2. Tear Monitoring

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

    Time frame: Up to 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05786300
Lead sponsor
Università degli studi di Roma Foro Italico
Responsible party
Sponsor
First posted
Mar 27, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Sep 26, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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