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NCT Number: 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

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.

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Key information

Conditions

Patellar Tendinopathy / Jumpers Knee

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paracelsus Sportmedizin & Prävention Bremen

Bremen, Free Hanseatic City of Bremen, 28205, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound guided electrolysis therapy

Device

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 Electrolysis

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

Gymna Uniphy

Industry

Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Paracelsus Klinik Bremen

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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