By InvitationNot Applicable

Comparison of Ultrasound-guided Electrolysis Therapy vs. Sham Electrolysis in Patients With Patellar Tendinopathy: A Prospective Randomized Study Including MRI and Shear-wave Ultrasound Elastography Imaging

Germany74 participantsStarted 2024-10-29

Plain-language summary

Study Background and Purpose Tendinopathies are common and debilitating musculoskeletal disorders that often lead to chronic pain and reduced mobility. Traditional treatments face challenges due to limited tendon blood supply, leading to poor healing. This study investigates ultrasound-guided galvanic electrolysis therapy (USGET), which uses electric current to promote tendon healing, comparing its efficacy with a placebo. Objectives The primary goal is to assess pain reduction, while secondary goals evaluate functionality, elasticity, and morphological changes (imaging) in patients with patellar tendinopathy. Methodology * Design: Prospective, randomized, double-blind, placebo-controlled study. * Duration: 24 months (October 2024 - October 2026). * Groups: * Intervention Group: Electrolysis therapy with galvanic current, Progressive tendon-loading exercises. * Control Group: Electrolysis placebo (without current), Progressive tendon-loading exercises. * Sample Size: 74 subjects. * Data Collection: Baseline, post-treatment (4 months), and follow-up (7 months). Evaluation and Data Analysis The study assesses pain via VAS and functionality scores, alongside imaging (MRI, sonography) to measure tendon morphology. Statistical analysis includes hypothesis testing and regression using SPSS software. Ethics and Publication Ethics approval is from the Bremen Medical Chamber. Results will be published regardless of outcome, following Good Clinical Practice and the Declaration of Helsinki.

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 18 - 59 years, * Informed consent (capable of giving consent), * Presentation and diagnosis of patella tendinopathy without other concomitant musculoskeletal diseases or degenerative joint disease. Exclusion Criteria: * Children (\< 18 years), age \> 59 years, * Pregnancy and breastfeeding, * Patients who are unable to give consent, * Musculoskeletal concomitant diseases such as fractures, sprains, dislocations, structural muscle injuries, meniscopathies, cruciate ligament injuries, * Joint diseases (acute, degenerative) such as arthrosis or arthritis, * Acute infections / open wounds in the area of the tendon to be examined * Other relevant damage to the tendon to be examined * Local steroid injections into the tendon before and after the start of the study, * Injections of vascular sclerosing agents before and after the start of the study, * Ingestion of fluoroquinolones, anticoagulants or anti-inflammatory drugs.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analogue Scale (VAS)

Timeframe: Change from baseline to the end of treatment at 10 weeks

Visual Analogue Scale (VAS)

Timeframe: Change from baseline to 7 months follow-up

Trial details

NCT IDNCT06939491

SponsorGymna Uniphy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More Patellar Tendinopathy / Jumpers Knee trials