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
NCT ID: NCT06939491
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
74 participants
INTERVENTIONAL
2024-10-29
2026-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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).
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
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.
Interventions
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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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent (capable of giving consent),
* Presentation and diagnosis of patella tendinopathy without other concomitant musculoskeletal diseases or degenerative joint disease.
Exclusion Criteria
* 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.
18 Years
59 Years
ALL
No
Sponsors
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Paracelsus Klinik Bremen
OTHER
Friedrich-Alexander-Universität Erlangen-Nürnberg
OTHER
Gymna Uniphy
INDUSTRY
Responsible Party
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Locations
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Paracelsus Sportmedizin & Prävention Bremen
Bremen, City state Bremen, Germany
Countries
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References
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Related Links
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The Acure 8000 is the device used for the ultrasound-guided-electrolysis therapy
Other Identifiers
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898
Identifier Type: -
Identifier Source: org_study_id
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