Clinical trial NCT06685302: Addition of Ultrasound-guided Percutaneous Neuromodulation to Ultrasound-guided Percutaneous Electrolysis and Eccentric Exercises in Patellar Tendinopathy.
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellar Tendinitis
Patella; Tendinitis
Patellar Tendinopathy / Jumpers Knee
Keywords: percutaneous neuromodulation
percutaneous electrolysis
eccentric exercise
patellar tendinopathy
jumper´s knee
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: Measurements will be conducted on day 1, 7, 14, 21 and 28
Secondary outcomes:
measure: Pain and Functionality
timeFrame: Measurements will be conducted on days 1 and 28
measure: Quality of Life
timeFrame: Measurements will be conducted on days 1 and 28
measure: Functionality
timeFrame: Measurements will be conducted on days 1 and 28
measure: Tendinous tissue condition
timeFrame: Measurements will be conducted on days 1 and 28
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: University of Zaragoza
Study officials:
affiliation: Universidad de Zaragoza
name: Pablo Herrero, Physiotherapist
role: STUDY_DIRECTOR
References: