NCT04427553

Brief 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. This study will evaluate changes in physical performance after the application of Percutaneous Peripheral Nerve Stimulation in a sample of healthy soccer players.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

June 4, 2020

Last Update Submit

December 4, 2020

Conditions

Keywords

Percutaneous Peripheral Nerve StimulationPerformanceSoccer

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Baseline and immediately after each session and 1 month after the last treatment session

Study Arms (2)

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.

Device: Percutaneous Peripheral Nerve Stimulation

Control

PLACEBO COMPARATOR

Participants in the control group will walk during 5 minutes, without receiving any intervention

Other: Control Group

Interventions

Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.

Percutaneous Peripheral Nerve Stimulation

No intervention

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • fear to needles
  • presence of pain or any musculoskeletal disease
  • previous surgery in the lower extremity
  • underlying medical conditions, e.g., diabetes, hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

César Fernández-de-las-Peñas

Alcorcón, Madrid, 28922, Spain

Location

César Fernández-de-las-Peñas

Alcorcón, Rest of the World, 28922, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full proffessor

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 11, 2020

Study Start

June 12, 2020

Primary Completion

November 25, 2020

Study Completion

December 4, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations