Hamstring InjuryNCT05786300
Effect of NMES+ on Hamstring Lesion (3a/3b)
A study testing NMES+ and Rehab in people with Hamstring Injury and Muscle Rupture, run by Università degli studi di Roma Foro Italico.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury, Muscle Rupture, Hamstring Sprain
- What is being tested?
- NMES+ and Rehab
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- recreational or semi-professional athletes
- Body Mass Index between 18,5 e 24,9
- Hamstring strain lesion type 3a/3b
Who cannot join
- previous hamstring strain lesions
- Anterior Cruciate Ligament Reconstruction using Hamstring graft
- Current hamstring strains
About this study
Official title: 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].
- Conditions
- Hamstring Injury, Muscle Rupture, Hamstring Sprain
- Being tested
- NMES+, Rehab
- Keywords
- Electrical Muscle Stimulation (EMS), NMES+, Hamstring strain injury, Neuromuscular Electrical Stimulation (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
RehabProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear monitoring and muscle quality
Healing status of the muscle tear (mm/cm), using ultrasounds
Measured: Baseline
Tear Monitoring
Healing status of the muscle tear (mm/cm), using ultrasounds
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli studi di Roma Foro Italico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786300
- Sponsor's protocol ID
- NMESHAMSTRING1
- Status last verified
- Sep 2023
- First submitted
- 1 Mar 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Early Superimposed Neuromuscular Electrical Stimulation (NMES+) Useful to Improve Muscle Tissue Recovery From Type 3a/3b Hamstring Strain Injuries (HSI)?
- ClinicalTrials.gov ID
- NCT05786300
- Acronym / sponsor ID
- NMESHAMSTRING1
- Conditions
- Hamstring Injury, Muscle Rupture, Hamstring Sprain
- Keywords
- Electrical Muscle Stimulation (EMS), NMES+, Hamstring strain injury, Neuromuscular Electrical Stimulation (NMES)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Università degli studi di Roma Foro ItalicoUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: NMES+, Procedure: RehabThe 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 | Active comparator | Procedure: RehabThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- recreational or semi-professional athletes
- Body Mass Index between 18,5 e 24,9
- Hamstring strain lesion type 3a/3b
Key exclusion criteria (3 listed)
- previous hamstring strain lesions
- Anterior Cruciate Ligament Reconstruction using Hamstring graft
- Current hamstring strains
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment Group |
| RehabThe 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. | Procedure or surgery | Control Group, Treatment Group |
Primary outcome
Tear monitoring and muscle quality
Time frame: Baseline
Healing status of the muscle tear (mm/cm), using ultrasounds
Tear Monitoring
Time frame: Up to 6 weeks
Healing status of the muscle tear (mm/cm), using ultrasounds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NMES+ and Rehab in people with Hamstring Injury and Muscle Rupture, run by Università degli studi di Roma Foro Italico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear monitoring and muscle quality (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.