Sports Physical TherapyNCT04427553
Percutaneous Peripheral Nerve Stimulation and Performance
A study testing Percutaneous Peripheral Nerve Stimulation in people with Sports Physical Therapy, run by Universidad Rey Juan Carlos at 2 sites in Spain.
Trial summary
Percutaneous Peripheral Nerve Stimulation is a relative new intervention applied by physical therapists. Although it has been hypothesized that this technique could improve pain and function, no studies have investigated changes in physical performance in soccer players. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Percutaneous Peripheral Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 12 Jun 2020to 4 Dec 2020
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- fear to needles
- presence of pain or any musculoskeletal disease
- previous surgery in the lower extremity
- underlying medical conditions, e.g., diabetes, hypertension
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
César Fernández-de-las-Peñas
Alcorcón, Madrid, 28922
César Fernández-de-las-Peñas
Alcorcón, Rest of the World, 28922
About this study
Official title: Effects of Percutaneous Peripheral Nerve Stimulation on Physical Performance in Soccer Players
Percutaneous Peripheral Nerve Stimulation is a relative new intervention applied by physical therapists. Although it has been hypothesized that this technique could improve pain and function, no studies have investigated changes in physical performance in soccer players. This study will evaluate changes in physical performance after the application of Percutaneous Peripheral Nerve Stimulation in a sample of healthy soccer players.
- Conditions
- Sports Physical Therapy
- Being tested
- Percutaneous Peripheral Nerve Stimulation, Control Group
- Keywords
- Percutaneous Peripheral Nerve Stimulation, Performance, Soccer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Peripheral Nerve StimulationDevice
Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.
Control GroupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Peripheral Nerve Stimulation | Experimental | 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. Receives: Device: Percutaneous Peripheral Nerve Stimulation |
| Control | Placebo comparator | Participants in the control group will walk during 5 minutes, without receiving any intervention Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Contra-Movement Jump between baseline and follow-up periods
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
Measured: Baseline and immediately after each session and 1 month after the last treatment session
Secondary outcomes (1)
Changes in Squat Performance Speed between baseline and follow-up periods
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
Measured: Baseline and immediately after each session and 1 month after the last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start12 Jun 2020
- Primary completion25 Nov 2020
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427553
- Sponsor's protocol ID
- URJC-UAX-02-2020
- Status last verified
- Dec 2020
- First submitted
- 4 Jun 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Percutaneous Peripheral Nerve Stimulation on Physical Performance in Soccer Players
- ClinicalTrials.gov ID
- NCT04427553
- Acronym / sponsor ID
- URJC-UAX-02-2020
- Conditions
- Sports Physical Therapy
- Keywords
- Percutaneous Peripheral Nerve Stimulation, Performance, Soccer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 11 Jun 2020 (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.
Percutaneous Peripheral Nerve Stimulation is a relative new intervention applied by physical therapists. Although it has been hypothesized that this technique could improve pain and function, no studies have investigated changes in physical performance in soccer players. This study will evaluate changes in physical performance after the application of Percutaneous Peripheral Nerve Stimulation in a sample of healthy soccer players.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Peripheral Nerve Stimulation | Experimental | Device: Percutaneous Peripheral Nerve StimulationParticipants 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. |
| Control | Placebo comparator | Other: Control GroupParticipants in the control group will walk during 5 minutes, without receiving any intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- fear to needles
- presence of pain or any musculoskeletal disease
- previous surgery in the lower extremity
- underlying medical conditions, e.g., diabetes, hypertension
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 |
|---|---|---|
| Percutaneous Peripheral Nerve StimulationParticipants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve. | Device | Percutaneous Peripheral Nerve Stimulation |
| Control GroupNo intervention | Other | Control |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Peripheral Nerve Stimulation in people with Sports Physical Therapy, run by Universidad Rey Juan Carlos at 2 sites in Spain.
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 4 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: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 8 Dec 2020.