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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Gymna Uniphy · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patellar Tendinopathy / Jumpers Knee

Interventions

Type	Name	Description
DEVICE	Ultrasound guided electrolysis therapy	Ultrasound-guided galvanic electrolysis (USGET) is a technique most commonly used on chronically affected tissue. A galvanic current flows through an acupuncture needle producing an inflammatory reaction in the tissue. The inflammatory reaction will trigger a host of biological processes in the body. These will ultimately start the generation of new immature collagen fibres. The fibres become mature by means of training stimulus. The technique shows good results on tendons in the chronic phase, and may be used for injuries, such as long-standing muscle injury and treatment of myofascial pain syndrome and trigger points.
DEVICE	Sham Electrolysis	The same intervention as the electrolysis group with the device turned on but the current intensity turned to 0 mA (e.g., no galvanic current).

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-07-31
• Completion: 2026-10-01
• First posted: 2025-04-22
• Last updated: 2025-04-30

Locations

1 site across 1 country: Germany