- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06685302
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Patellar tendinopathy, also known as "jumper's knee," is one of the most common conditions affecting the patellar tendon. It involves degeneration of the tendon, primarily due to excessive structural overuse. This condition leads to various changes within the tissue, including tendon thickening, collagen fiber degeneration and disorganization, disruption in the parallel alignment of healthy collagen fibers, fibroblast proliferation with incomplete injury repair, neovascularization, and neurogenesis. Various studies indicate a high prevalence of patellar tendinopathy among athletes and the general population, with rates of 0.1% and 18.3%, respectively. The condition is more frequently observed in males over 18 who participate in sports such as volleyball, basketball, or football.
Clinical symptoms of patellar tendinopathy include anterior knee pain that worsens with exercise, post-exercise, or during prolonged knee flexion; localized pain and tenderness at the proximal tendon insertion; and functional impairment in actions such as squatting with ankle plantar flexion.There are different diagnostic methods, both medical and physiotherapeutic, to determine the presence of patellar tendinopathy. In this context, imaging evaluations through ultrasound show potential as diagnostic and follow-up tool.
Only in advanced stages of tendon degeneration is surgical treatment considered, which may involve open surgery or arthroscopy. Among non-surgical treatments for patellar tendinopathy, medical options focus on platelet-rich plasma injections, hyaluronic acid, nonsteroidal anti-inflammatory drugs, or corticosteroids. However, conservative physiotherapy is typically the first choice, generally based on eccentric exercises, and invasive techniques such as percutaneous electrolysis or percutaneous neuromodulation.
Current literature provides evidence supporting percutaneous electrolysis, percutaneous neuromodulation and eccentric exercises as therapeutic methods for tendinopathies. However, there is presently no evidence or studies regarding the combination of these three techniques.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zaragoza
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Zaragoza, Zaragoza, Spain, 50009
- University of Zaragoza
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: US-PNM + US-PE + EE
Patients receive three interventions: ultrasound-guided percutaneous neuromodulation, ultrasound-guided percutaneous electrolysis and eccentric exercises
|
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.
|
|
Active Comparator: US-PE + EE
Patients receive two interventions: ultrasound-guided percutaneous electrolysis and eccentric exercises
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: Measurements will be conducted on day 1, 7, 14, 21 and 28
|
This will be measured using the Visual Analog Scale (VAS).
Minimum and maximum values are 1-10, being 10 worst possible pain
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Measurements will be conducted on day 1, 7, 14, 21 and 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain and Functionality
Time Frame: Measurements will be conducted on days 1 and 28
|
This will be measured using the VISA-P questionnaire
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Measurements will be conducted on days 1 and 28
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Quality of Life
Time Frame: Measurements will be conducted on days 1 and 28
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This will be measured using the SF-36 questionnaire
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Measurements will be conducted on days 1 and 28
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Functionality
Time Frame: Measurements will be conducted on days 1 and 28
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This will be measured using the pistol squat exercise
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Measurements will be conducted on days 1 and 28
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Tendinous tissue condition
Time Frame: Measurements will be conducted on days 1 and 28
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This will be measured using ultrasonography
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Measurements will be conducted on days 1 and 28
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pablo Herrero, Physiotherapist, Universidad de Zaragoza
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PNM, PES and EE in PT. ECA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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