- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637439
Neuromodulation in Patients With Hamstring Shortening
Effects of Ultrasound-guided Percutaneous Neuromodulation on Flexibility and Hamstring Force
The flexibility of the hamstrings is a very important component both for general health and when exercising. The lack of hamstring flexibility has been related to the increase in the likelihood of suffering a large number of musculoskeletal pathologies, due to the possibility of causing important muscle imbalances, which include lumbar spine pathologies, such as disc hernias or spondyloarthrosis. In addition, the decrease in the flexibility of the hamstring musculature is also related to the increased likelihood of suffering muscle strains, patellar tendon tendinopathies, femoropatellar syndrome and decreased lumbopelvic rhythm.
Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the application of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.
The aim of this study was to examine the effects on flexibility and strength of an ultrasound-guided percutaneous neuromodulation intervention in patients with shortening of the hamstring muscles.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Murcia, Spain, 30100
- Physical Therapy Department. University of Murcia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- over 18 years
- to practice some sports activity 2 or more times a week
- get less than 70º in PKE (Passive Knee Extension) with hip 90º
Exclusion Criteria:
- any previous surgery or acute trauma in the back or lower extremity.
- pain at the time of performing the assessment tests
- belonephobia
- anticoagulant consumption
- pregnancy
- hemorrhagic disorders
- immunosuppression
- inability to understand or carry out evaluations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNM group
Subjects were treated only once.
Specifically, this consisted in the application of a square wave biphasic electrical current, with 10 Hz frequency, a 250µs pulse width, and the maximal tolerable intensity to cause an exacerbated muscle contraction for a total of 1.5 mins, according to the protocol (Valera & Minaya).
The subjects were lying prone in decubitus.
The middle part of the sciatic nerve was located using an ultrasound machine (cross section), then an acupuncture needle (0.30 mm x 40 mm) was inserted in a short axis approach, perpendicular to the surface of the skin, to the perineurium of the sciatic nerve.
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It's a new intervention of sport physiotherapy.
It´s an invasive technique.
It is necessary an ultrasound
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Sham Comparator: Control group
The subjects were lying prone in decubitus.
The same puncture protocol was performed on the sciatic nerve for 1.5 minutes, but without the application of electricity.
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Same protocol without electricity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Passive Knee Extension 90º [PKE 90º] [Hamstring Flexibility test] 5 minutes after intervention
Time Frame: Baseline and 5 minutes after intervention
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Passive Knee Extension with hip 90º.
The examiner will measure the popliteal angle (between the femur and the tibia) with a goniometer.
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Baseline and 5 minutes after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Sit and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
Time Frame: Baseline and 5 minutes after intervention
|
The sit and reach test is a common measure of flexibility of the lower back and hamstring muscles.
Using a standard sit and reach box, the participant sat on the floor with shoes on, and fully extended one leg so that the sole of the foot was flat against the end of the box.
She then extended her arms forward, placing one hand on top of the other.
With palms down, she reached forward sling hands along the measuring scale as far as possible without bending the knee of the extended leg.
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Baseline and 5 minutes after intervention
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Change from Stand and Reach Flexibility Test [Hamstring Flexibility test] 5 minutes after intervention
Time Frame: Baseline and 5 minutes after intervention
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The volunteer standing with his knees extended tries to touch the ground with his extended hands.
The examiner will measure with a ruler the distance in centimeters between the floor and the tips of fingers.
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Baseline and 5 minutes after intervention
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1858/2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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