- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427553
Percutaneous Peripheral Nerve Stimulation and Performance
Effects of Percutaneous Peripheral Nerve Stimulation on Physical Performance in Soccer Players
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- César Fernández-de-las-Peñas
-
-
Rest Of The World
-
Alcorcon, Rest Of The World, Spain, 28922
- César Fernández-de-las-Peñas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Semiprofessional soccer player
- No symptoms or injury in the lower extremity previous 6 months
- Training frequency of at least 3 days a week plus soccer game
Exclusion Criteria:
- fear to needles
- presence of pain or any musculoskeletal disease
- previous surgery in the lower extremity
- underlying medical conditions, e.g., diabetes, hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Percutaneous Peripheral Nerve Stimulation
Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve. We will apply a biphasic compensated electrical current at a frequency of 10 Hz, a pulse width of 240 µs and intensity allowed over a pain-free motor threshold (muscle contraction). Each participant will receive 10 repetitions of 10 seconds each one with 10 seconds rest- period between series (total treatment session 1.40 min). After that participants will walk during 3 minutes. |
Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.
|
Placebo Comparator: Control
Participants in the control group will walk during 5 minutes, without receiving any intervention
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Contra-Movement Jump between baseline and follow-up periods
Time Frame: Baseline and immediately after each session and 1 month after the last treatment session
|
The jump will start in an upright position with participants hands in their waists.
They will perform a vertical jump after a fast down countermovement.
During the knees and hips flexion, the trunk will remain the most upright as possible.
The jump is measured using a Chronopump-Boscosystem DIN-A2 contact platform obtaining a jump reliable and valid height in centimeters
|
Baseline and immediately after each session and 1 month after the last treatment session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Squat Performance Speed between baseline and follow-up periods
Time Frame: Baseline and immediately after each session and 1 month after the last treatment session
|
The Speed4Lift device will be used.
Squats will be performed using a 20kg olympic bar with two 20kg discs in each side.
Participants will place the bar over their shoulders in a 90º triple-flexion position.
The measurements will be performed during the concentric contraction phase of the squat
|
Baseline and immediately after each session and 1 month after the last treatment session
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- URJC-UAX-02-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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