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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ultrasound-guided galvanic electrolysis (USGET)
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
Intervention: Ultrasound guided electrolysis therapy (Device)
Sham Electrolysis
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.
Intervention: Sham Electrolysis (Device)
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS)
Time Frame: Change from baseline to 7 months follow-up
The pain Visual Analogue Scale (VAS) is a subjective, unidimensional measure of pain intensity, used to record patients' pain progression. It is a horizontal line, 100 mm in length, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.
Visual Analogue Scale (VAS)
Time Frame: Change from baseline to the end of treatment at 10 weeks
The pain Visual Analogue Scale (VAS) is a subjective, unidimensional measure of pain intensity, used to record patients' pain progression. It is a horizontal line, 100 mm in length, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.
Secondary Outcomes
- International Knee Documentation Committee score(Change from baseline to 7 months follow-up)
- Tegner Activity Scale(Change from baseline to 7 months follow-up)
- Visa-P(Change from baseline to 7 months follow-up)
- Comprehensive Aachen Knee Score(Change from baseline to 7 months follow-up)
- B-scan sonography(Change from baseline to 7 months follow-up)
- Doppler sonography(Change from baseline to 7 months follow-up)
- Shear wave elastography(Change from baseline to 7 months follow-up)
- Magnetic resonance imaging(Change from baseline to 7 months follow-up)
- International Knee Documentation Committee score(Change from baseline to the end of treatment at 10 weeks)
- Tegner Activity Scale(Change from baseline to the end of treatment at 10 weeks)
- Visa-P(Change from baseline to the end of treatment at 10 weeks)
- Comprehensive Aachen Knee Score(Change from baseline to the end of treatment at 10 weeks)
- B-scan sonography(Change from baseline to the end of treatment at 10 weeks)
- Doppler sonography(Change from baseline to the end of treatment at 10 weeks)
- Shear wave elastography(Change from baseline to the end of treatment at 10 weeks)
- Magnetic resonance imaging(Change from baseline to the end of treatment at 10 weeks)