Addition of Ultrasound-guided Percutaneous Neuromodulation to Ultrasound-guided Percutaneous Electrolysis and Eccentric Exercises in Patellar Tendinopathy.
Effect of Adding Ultrasound-guided Percutaneous Neuromodulation to Conventional Treatment of Ultrasound-guided Percutaneous Electrolysis and Eccentric Exercises in Patients With Patellar Tendinopathy. Randomized Clinical Trial
1 other identifier
interventional
26
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
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
November 9, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2025
CompletedDecember 4, 2025
November 1, 2025
4 months
November 9, 2024
November 27, 2025
Conditions
Keywords
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
EXPERIMENTALPatients receive three interventions: ultrasound-guided percutaneous neuromodulation, ultrasound-guided percutaneous electrolysis and eccentric exercises
US-PE + EE
ACTIVE COMPARATORPatients receive two interventions: ultrasound-guided percutaneous electrolysis and eccentric exercises
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.
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pablo Herrero, Physiotherapist
Universidad de Zaragoza
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
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Once research has been published
- Access Criteria
- Study protocol will be publish in a scientific journal
Data will be shared on a reasonable request contacting with the main author once data has been published.