NCT06685302

Brief Summary

Patellar tendinopathy, or "jumper's knee," is a prevalent condition involving patellar tendon degeneration due to structural overuse, common among athletes, particularly males over 18 in sports like volleyball, basketball, or football. It causes tendon thickening, collagen disorganization, fibroblast proliferation, neovascularization, and neurogenesis. Symptoms include anterior knee pain that worsens with activity, tenderness at the proximal tendon insertion, and functional limitations. Diagnosis often utilizes ultrasound imaging. While surgical treatment is reserved for severe cases, non-surgical options prioritize physiotherapy-especially eccentric exercises and newer invasive techniques like percutaneous electrolysis and neuromodulation. However, there is still no research on the effects when combining these three treatment options.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 9, 2024

Last Update Submit

November 27, 2025

Conditions

Keywords

percutaneous neuromodulationpercutaneous electrolysiseccentric exercisepatellar tendinopathyjumper´s knee

Outcome Measures

Primary Outcomes (1)

  • Pain

    This will be measured using the Visual Analog Scale (VAS). Minimum and maximum values are 1-10, being 10 worst possible pain

    Measurements will be conducted on day 1, 7, 14, 21 and 28

Secondary Outcomes (4)

  • Pain and Functionality

    Measurements will be conducted on days 1 and 28

  • Quality of Life

    Measurements will be conducted on days 1 and 28

  • Functionality

    Measurements will be conducted on days 1 and 28

  • Tendinous tissue condition

    Measurements will be conducted on days 1 and 28

Study Arms (2)

US-PNM + US-PE + EE

EXPERIMENTAL

Patients receive three interventions: ultrasound-guided percutaneous neuromodulation, ultrasound-guided percutaneous electrolysis and eccentric exercises

Other: US-guided PNMOther: US-guided PE

US-PE + EE

ACTIVE COMPARATOR

Patients receive two interventions: ultrasound-guided percutaneous electrolysis and eccentric exercises

Other: US-guided PEOther: EE

Interventions

The patient will be positioned in supine with approximately 20 degrees of knee flexion, supported by a cushion. The treatment area is sterilized in advance with 2% chlorhexidine, and new needles and ultrasound probe covers are used for each intervention. The femoral nerve is targeted under ultrasound guidance, just distal to the inguinal ligament, with an electrode patch placed on the patellar tendon to complete the circuit. A current of 2 Hz, 250 μs pulse width, and variable intensity is applied to reach the patient's comfortable contraction threshold without inducing pain, for a duration of 25 minutes, following the protocol established by MVClinic Institute. This intervention will be performed on the first day, at 7 days, and at 14 days, following the previously mentioned protocol.

US-PNM + US-PE + EE

The patient will be positioned in supine with approximately 20º of knee flexion, supported by a cushion. Prior to the EP procedure, the treatment area will be sterilized with 2% chlorhexidine, and new needles and ultrasound probe covers will be used for each session. Three EP interventions will be performed under ultrasound guidance following the protocol developed by MVClinic Institute (2) for treating tendinopathies, using a longitudinal, long-axis view of the patellar tendon. A galvanic current of 3 mA will be applied for 3 seconds, with slight three-dimensional adjustments in needle placement after each impact to administer a total of 3 impacts on the target tissue. This intervention will be performed on the first day, at 7 days, and at 14 days, following the previously mentioned protocol.

US-PE + EEUS-PNM + US-PE + EE
EEOTHER

Three sets of 15 repetitions of single-leg squats on a 25º inclined plane, performed twice daily, following Young's protocol for patellar tendinopathies. The speed of execution may be increased as long as, if there is pain during the exercise, it does not exceed a 2-3 on the VAS scale.

US-PE + EE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 50 years
  • Experiencing localized anterior knee pain at the lower pole of the patella for at least two weeks
  • Engaging in any type of sport at least three times per week
  • Scoring less than 80 points on the VISA-P questionnaire in its Spanish version
  • Having carefully read and signed the study's informed consent form

You may not qualify if:

  • Any contraindication for invasive techniques (such as belonephobia, allergies to materials used, cancer, thrombophlebitis, skin conditions, or febrile states)
  • Any lower limb pathology or severe chronic condition (e.g., Osgood-Schlatter syndrome or Sinding-Larsen-Johansson syndrome)
  • Pharmacological treatment within the 48 hours prior to the intervention
  • Knee surgeries within the past year
  • Corticosteroid injections within the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Patella FractureTendinopathy

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesTendon Injuries

Study Officials

  • Pablo Herrero, Physiotherapist

    Universidad de Zaragoza

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2024

First Posted

November 12, 2024

Study Start

May 1, 2025

Primary Completion

August 31, 2025

Study Completion

November 27, 2025

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Data will be shared on a reasonable request contacting with the main author once data has been published.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Once research has been published
Access Criteria
Study protocol will be publish in a scientific journal

Locations