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

April 28, 2025 updated by: Gymna Uniphy

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 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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bremen, Germany, 28205
        • Paracelsus Sportmedizin & Prävention Bremen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.

Other Names:
  • USGET
Sham Comparator: 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.
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).
Other Names:
  • Sham Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to the end of treatment at 10 weeks
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.
Change from baseline to 7 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tegner Activity Scale
Time Frame: Change from baseline to the end of treatment at 10 weeks
The Tegner Activity Scale (TAS) is a one-item score used to measure activity level, particularly in the context of knee injuries and sports. It uses a scale of 0 to 10, where 0 represents maximum disability and 10 represents participation in competitive sports at a national or international elite level.
Change from baseline to the end of treatment at 10 weeks
Tegner Activity Scale
Time Frame: Change from baseline to 7 months follow-up
The Tegner Activity Scale (TAS) is a one-item score used to measure activity level, particularly in the context of knee injuries and sports. It uses a scale of 0 to 10, where 0 represents maximum disability and 10 represents participation in competitive sports at a national or international elite level.
Change from baseline to 7 months follow-up
Visa-P
Time Frame: Change from baseline to the end of treatment at 10 weeks
The Visa-P questionnaire (Victorian Institute of Sport Assessment - Patella) is a self-reported outcome measure that evaluates symptoms, function and the ability to play sports. The questionnaire consists of 8 questions designed to assess the patient's pain and functional ability during patellofemoral loading activities. The total score ranges from 0 to 100, with 100 representing an asymptomatic individual able to fully engage in sports and 0 representing the worst possible outcome.
Change from baseline to the end of treatment at 10 weeks
Visa-P
Time Frame: Change from baseline to 7 months follow-up
The Visa-P questionnaire (Victorian Institute of Sport Assessment - Patella) is a self-reported outcome measure that evaluates symptoms, function and the ability to play sports. The questionnaire consists of 8 questions designed to assess the patient's pain and functional ability during patellofemoral loading activities. The total score ranges from 0 to 100, with 100 representing an asymptomatic individual able to fully engage in sports and 0 representing the worst possible outcome.
Change from baseline to 7 months follow-up
International Knee Documentation Committee score
Time Frame: Change from baseline to the end of treatment at 10 weeks
The International Knee Documentation Committee score (IKDC) is a tool used to assess knee function and symptoms. It's a patient-completed questionnaire that helps quantify how a person's knee is affecting their daily activities and sports participation. The score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms.
Change from baseline to the end of treatment at 10 weeks
International Knee Documentation Committee score
Time Frame: Change from baseline to 7 months follow-up
The International Knee Documentation Committee score (IKDC) is a tool used to assess knee function and symptoms. It's a patient-completed questionnaire that helps quantify how a person's knee is affecting their daily activities and sports participation. The score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms.
Change from baseline to 7 months follow-up
Comprehensive Aachen Knee Score
Time Frame: Change from baseline to the end of treatment at 10 weeks
The Comprehensive Aachen Knee Score (COMPACK) is a novel, reliable and valid instrument to measure knee pain regarding two dimensions, intensity and frequency from the patient perspective. The total score consist of two subscales and ranges from 0 (no pain or frequency of pain) to 60 (the worst possible pain and pain frequency).
Change from baseline to the end of treatment at 10 weeks
Comprehensive Aachen Knee Score
Time Frame: Change from baseline to 7 months follow-up
The Comprehensive Aachen Knee Score (COMPACK) is a novel, reliable and valid instrument to measure knee pain regarding two dimensions, intensity and frequency from the patient perspective. The total score consist of two subscales and ranges from 0 (no pain or frequency of pain) to 60 (the worst possible pain and pain frequency).
Change from baseline to 7 months follow-up
B-scan sonography
Time Frame: Change from baseline to the end of treatment at 10 weeks
B-scan sonography, or ultrasound imaging, is a valuable tool for assessing tendon conditions. It allows visualization of tendon structure, dimensions, and potential pathologies like tears or inflammation. B-mode ultrasound can show the fibrillar pattern of normal tendons and help identify abnormalities, such as the presence of tears or the degree of tendon retraction in cases of rupture
Change from baseline to the end of treatment at 10 weeks
B-scan sonography
Time Frame: Change from baseline to 7 months follow-up
B-scan sonography, or ultrasound imaging, is a valuable tool for assessing tendon conditions. It allows visualization of tendon structure, dimensions, and potential pathologies like tears or inflammation. B-mode ultrasound can show the fibrillar pattern of normal tendons and help identify abnormalities, such as the presence of tears or the degree of tendon retraction in cases of rupture
Change from baseline to 7 months follow-up
Doppler sonography
Time Frame: Change from baseline to the end of treatment at 10 weeks
Doppler sonography, a type of ultrasound, is used to assess blood flow within tendons, particularly in conditions like tendinopathy or tendinosis. It can help visualize neovascularization (new blood vessel formation) within abnormal tendons.
Change from baseline to the end of treatment at 10 weeks
Doppler sonography
Time Frame: Change from baseline to 7 months follow-up
Doppler sonography, a type of ultrasound, is used to assess blood flow within tendons, particularly in conditions like tendinopathy or tendinosis. It can help visualize neovascularization (new blood vessel formation) within abnormal tendons.
Change from baseline to 7 months follow-up
Shear wave elastography
Time Frame: Change from baseline to the end of treatment at 10 weeks
Shear wave elastography (SWE) is a non-invasive ultrasound technique that can be used to assess tendon stiffness and elasticity. It measures the speed of shear waves as they travel through the tendon, which can be related to the tissue's mechanical properties. SWE can help differentiate between healthy and pathological tendons, potentially aiding in the diagnosis and monitoring of tendinopathies
Change from baseline to the end of treatment at 10 weeks
Shear wave elastography
Time Frame: Change from baseline to 7 months follow-up
Shear wave elastography (SWE) is a non-invasive ultrasound technique that can be used to assess tendon stiffness and elasticity. It measures the speed of shear waves as they travel through the tendon, which can be related to the tissue's mechanical properties. SWE can help differentiate between healthy and pathological tendons, potentially aiding in the diagnosis and monitoring of tendinopathies
Change from baseline to 7 months follow-up
Magnetic resonance imaging
Time Frame: Change from baseline to the end of treatment at 10 weeks
Magnetic resonance imaging (MRI) can be used to assess tendinopathy, by detecting structural changes and inflammatory processes. It's particularly useful for evaluating partial tears and postoperative assessment, offering better visualization than ultrasound in these situations. MRI can also identify other associated injuries like cartilage damage, bone abnormalities, and ligament injuries
Change from baseline to the end of treatment at 10 weeks
Magnetic resonance imaging
Time Frame: Change from baseline to 7 months follow-up
Magnetic resonance imaging (MRI) can be used to assess tendinopathy, by detecting structural changes and inflammatory processes. It's particularly useful for evaluating partial tears and postoperative assessment, offering better visualization than ultrasound in these situations. MRI can also identify other associated injuries like cartilage damage, bone abnormalities, and ligament injuries
Change from baseline to 7 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gymna Uniphy

Collaborators

Friedrich-Alexander-Universität Erlangen-Nürnberg
Paracelsus Klinik Bremen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 898 (HCL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

01.08.2026 until 31.12.2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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