NCT07237867

Brief Summary

This study investigates the immediate effects of different peripheral electrical nerve stimulation protocols applied to the femoral nerve on quadriceps strength in athletes with patellar tendinopathy. Patellar tendinopathy is a common overuse injury that often reduces quadriceps activation and limits sports performance. Peripheral percutaneous nerve stimulation (PPNS) and transcutaneous electrical nerve stimulation (TENS) are frequently used in rehabilitation, but their frequency-dependent effects on muscle strength are not well established. In this randomized crossover trial, each participant receives three stimulation protocols in separate sessions: high-frequency PPNS (100 Hz), low-frequency PPNS (2 Hz), and conventional TENS. All stimulation is delivered at the maximal tolerated motor threshold and, for PPNS conditions, under ultrasound guidance. Quadriceps maximal isometric strength is evaluated using an isometric force sensor before and after each intervention. The primary objective is to compare the acute changes in maximal voluntary contraction (MVC) following each stimulation protocol. The study aims to clarify whether different stimulation frequencies can enhance, reduce, or have no effect on quadriceps strength in this athletic population. By identifying frequency-specific neuromodulatory responses, this study may help clinicians and sports practitioners select the most appropriate stimulation parameters to optimize rehabilitation and performance in individuals with patellar tendinopathy.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

September 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 15, 2025

Last Update Submit

November 29, 2025

Conditions

Keywords

Peripheral Percutaneous Nerve StimulationTranscutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in Quadriceps Maximal Isometric Voluntary Contraction (MVC)

    Quadriceps maximal isometric voluntary contraction (MVC) is measured using a calibrated isometric force sensor with the participant seated and the knee positioned at 60° of flexion. MVC is recorded as the peak force output during a standardized 5-second maximal contraction. The primary endpoint is the change in MVC from pre-intervention to immediately post-intervention across the three stimulation conditions (high-frequency PPNS, low-frequency PPNS, and TENS). Higher values indicate greater quadriceps force production.

    Baseline (pre-intervention), and at 2 minutes, 10 minutes, 15 minutes, and 30 minutes post-intervention.

Secondary Outcomes (3)

  • Change in Quadriceps Rate of Force Development (RFD 0-250 ms)

    Baseline (pre-intervention), and at 2 minutes, 10 minutes, 15 minutes, and 30 minutes post-intervention.

  • Change in Quadriceps Impulse (0-250 ms)

    Baseline (pre-intervention), and at 2 minutes, 10 minutes, 15 minutes, and 30 minutes post-intervention.

  • Incidence of Adverse Events Assessed Through Post-Intervention Questionnaires

    Immediately after each intervention session.

Study Arms (3)

High-Frequency PPNS (100 Hz)

EXPERIMENTAL

Participants receive peripheral percutaneous nerve stimulation (PPNS) applied to the femoral nerve at 100 Hz.

Device: Electrical stimulation

Low-Frequency PPNS (2 Hz)

EXPERIMENTAL

Participants receive peripheral percutaneous nerve stimulation (PPNS) applied to the femoral nerve at 2 Hz.

Device: Electrical stimulation

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

Participants receive conventional transcutaneous electrical nerve stimulation (TENS) applied over the femoral nerve region using surface electrodes. Intensity is set at the maximal tolerated motor threshold to elicit visible quadriceps activation. The stimulation frequency and parameters are consistent with standard clinical practice for motor-level TENS.

Device: Electrical stimulation

Interventions

All electrical stimulation procedures are performed under real-time ultrasound guidance to accurately locate the femoral nerve and ensure safe and consistent electrode placement. For the percutaneous interventions (PPNS), a sterile needle electrode is inserted adjacent to the femoral nerve and stimulation is delivered at either high frequency (100 Hz) or low frequency (2 Hz), depending on the study arm. For the transcutaneous intervention (TENS), surface electrodes are positioned over the femoral nerve region using ultrasound guidance to confirm anatomical landmarks and optimize current delivery. In all conditions, stimulation is applied at the maximal tolerated motor threshold to elicit visible quadriceps activation.

Also known as: Ultrasound-guided electrical stimulation
High-Frequency PPNS (100 Hz)Low-Frequency PPNS (2 Hz)Transcutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18 to 40 years.
  • Recreational or competitive athletes with clinically diagnosed patellar tendinopathy for at least 3 months.
  • Ultrasound-confirmed patellar tendinopathy, including hypoechoic areas, tendon thickening, or neovascularization consistent with clinical diagnosis.
  • Presence of pain during tendon-loading activities (e.g., jumping, running, squatting).
  • Ability to perform maximal voluntary isometric contractions of the quadriceps.
  • Ability to comply with all study procedures and attend all experimental sessions.
  • Written informed consent obtained prior to participation.

You may not qualify if:

  • Previous knee surgery or traumatic knee injury within the past 12 months.
  • Complete or partial patellar tendon rupture.
  • Neurological disorders affecting lower limb strength or motor control.
  • Contraindications to electrical stimulation, including implanted electrical devices (e.g., pacemaker).
  • Current lower-limb radiculopathy or neuropathy.
  • Skin infections, open wounds, or dermatological conditions at the stimulation site.
  • Use of analgesics, anti-inflammatories, or corticosteroid injections within the past 48 hours.
  • Participation in another interventional study in the previous 30 days.
  • Pregnancy or suspected pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blanquerna University

Barcelona, Barcelona, 08020, Spain

RECRUITING

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Central Study Contacts

Javier Picañol Parraga Picañol, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd in Neuroscience

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 20, 2025

Study Start

September 20, 2025

Primary Completion

November 30, 2025

Study Completion

December 15, 2025

Last Updated

December 5, 2025

Record last verified: 2025-11

Locations