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

Gymna Uniphy

Status: Invitation-only

Conditions: Patellar Tendinopathy / Jumpers Knee

Treatments: Device: Sham Electrolysis; Device: Ultrasound guided electrolysis therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06939491

898

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Ultrasound-guided galvanic electrolysis (USGET)

Experimental group

Description:

The patients randomized in this group will receive the ultrasound-guided-electrolysis-therapy (acupuncture treatment including galvanic current, 5 applications at intervals of 2 weeks) + PTLE-Training protocol. Local peritendinous injection of the local anaesthetic mepivacaine (manufacturer: Puren, dosage: 10mg/ml, dose: 20mg (2ml), concentration: 1%) before performing electrolysis. The treatment period is 4 months, follow-up period totalling 3 months

Treatment:

Device: Ultrasound guided electrolysis therapy

Sham Electrolysis

Sham Comparator group

Description:

The patients randomized in this group will receive the sham-electrolysis with a current intensity of 0 mA (acupuncture treatment without galvanic current, 5 applications at intervals of 2 weeks) + PTLE-training protocol. Local peritendinous injection of the local anaesthetic mepivacaine (manufacturer: Puren, dosage: 10mg/ml, dose: 20mg (2ml), concentration: 1%) before performing sham electrolysis. The treatment period is 4 months, follow-up period totalling 3 months.

Treatment:

Device: Sham Electrolysis