Clinical trial NCT06939491: 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
Official title: Comparison of Ultrasound-Guided Electrolysis Therapy (USGET) vs. Sham USGET on Patients With Patellar Tendinopathy: A Randomized Controlled Trial (RCT) Assessing the Effects on Pain, Function, and Tendon Structure Including MRI and Shear-wave Elastography Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Patellar Tendinopathy / Jumpers Knee
Keywords: patellar tendinopathy
jumpers knee
ultra-sound-guided-electrolysis
electrolysis
galvanic current
USGET
Lead sponsor: Gymna Uniphy
Sponsor class: INDUSTRY
Collaborators: name: Paracelsus Klinik Bremen
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
First posted: 2025-04-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 7 months follow-up
Secondary outcomes:
measure: Tegner Activity Scale
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: Tegner Activity Scale
timeFrame: Change from baseline to 7 months follow-up
measure: Visa-P
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: Visa-P
timeFrame: Change from baseline to 7 months follow-up
measure: International Knee Documentation Committee score
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: International Knee Documentation Committee score
timeFrame: Change from baseline to 7 months follow-up
measure: Comprehensive Aachen Knee Score
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: Comprehensive Aachen Knee Score
timeFrame: Change from baseline to 7 months follow-up
measure: B-scan sonography
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: B-scan sonography
timeFrame: Change from baseline to 7 months follow-up
measure: Doppler sonography
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: Doppler sonography
timeFrame: Change from baseline to 7 months follow-up
measure: Shear wave elastography
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: Shear wave elastography
timeFrame: Change from baseline to 7 months follow-up
measure: Magnetic resonance imaging
timeFrame: Change from baseline to the end of treatment at 10 weeks
measure: Magnetic resonance imaging
timeFrame: Change from baseline to 7 months follow-up
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Paracelsus Sportmedizin & Prävention Bremen
Study officials:
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