Patellar Tendinopathy / Jumpers KneeNCT06939491
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
A study testing Ultrasound guided electrolysis therapy in people with Patellar Tendinopathy / Jumpers Knee, run by Gymna Uniphy at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Patellar Tendinopathy / Jumpers Knee
- What is being tested?
- Ultrasound guided electrolysis therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- 29 Oct 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Paracelsus Sportmedizin & Prävention Bremen
Bremen, Free Hanseatic City of Bremen, 28205
About this study
Official 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
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.
Read more
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.
- Conditions
- Patellar Tendinopathy / Jumpers Knee
- Being tested
- Ultrasound guided electrolysis therapy, Sham Electrolysis
- Keywords
- patellar tendinopathy, jumpers knee, ultra-sound-guided-electrolysis, electrolysis, galvanic current, USGET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided electrolysis therapyDevice
Also called USGET
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 ElectrolysisDevice
Also called Sham Treatment
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).
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided galvanic electrolysis (USGET) | Experimental | 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 Receives: Device: Ultrasound guided electrolysis therapy |
| Sham Electrolysis | Sham comparator | 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. Receives: Device: Sham Electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
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.
Measured: Change from baseline to the end of treatment at 10 weeks
Visual Analogue Scale (VAS)
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.
Measured: Change from baseline to 7 months follow-up
Secondary outcomes (16)
Tegner Activity Scale
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.
Measured: Change from baseline to the end of treatment at 10 weeks
Tegner Activity Scale
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.
Measured: Change from baseline to 7 months follow-up
Visa-P
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.
Measured: Change from baseline to the end of treatment at 10 weeks
Visa-P
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.
Measured: Change from baseline to 7 months follow-up
International Knee Documentation Committee score
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.
Measured: Change from baseline to the end of treatment at 10 weeks
International Knee Documentation Committee score
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.
Measured: Change from baseline to 7 months follow-up
Comprehensive Aachen Knee Score
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).
Measured: Change from baseline to the end of treatment at 10 weeks
Comprehensive Aachen Knee Score
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).
Measured: Change from baseline to 7 months follow-up
B-scan sonography
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
Measured: Change from baseline to the end of treatment at 10 weeks
B-scan sonography
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
Measured: Change from baseline to 7 months follow-up
Doppler sonography
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.
Measured: Change from baseline to the end of treatment at 10 weeks
Doppler sonography
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.
Measured: Change from baseline to 7 months follow-up
Shear wave elastography
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
Measured: Change from baseline to the end of treatment at 10 weeks
Shear wave elastography
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
Measured: Change from baseline to 7 months follow-up
Magnetic resonance imaging
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
Measured: Change from baseline to the end of treatment at 10 weeks
Magnetic resonance imaging
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
Measured: Change from baseline to 7 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start29 Oct 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Patellar Tendinopathy / Jumpers KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gymna Uniphy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paracelsus Klinik Bremen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939491
- Sponsor's protocol ID
- 898
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Risch L, Wochatz M, Messerschmidt J, Engel T, Mayer F, Cassel M. Reliability of Evaluating Achilles Tendon Vascularization Assessed With Doppler Ultrasound Advanced Dynamic Flow. J Ultrasound Med. 2018 Mar;37(3):737-744. doi: 10.1002/jum.14414. Epub 2017 Sep 28.
PubMed 28960372Krott NL, Wild M, Betsch M. The Comprehensive Aachen Knee Score: Development and validation of a new patient-reported outcome measure for patellofemoral pathologies. Knee. 2021 Oct;32:112-120. doi: 10.1016/j.knee.2021.08.010. Epub 2021 Aug 27.
PubMed 34461387Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
PubMed 17888709Hernandez-Sanchez S, Hidalgo MD, Gomez A. Responsiveness of the VISA-P scale for patellar tendinopathy in athletes. Br J Sports Med. 2014 Mar;48(6):453-7. doi: 10.1136/bjsports-2012-091163. Epub 2012 Sep 25.
PubMed 23012320Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
PubMed 4028566Larrivee S, Balg F, Leonard G, Bedard S, Tousignant M, Boissy P. Wrist-Based Accelerometers and Visual Analog Scales as Outcome Measures for Shoulder Activity During Daily Living in Patients With Rotator Cuff Tendinopathy: Instrument Validation Study. JMIR Rehabil Assist Technol. 2019 Dec 3;6(2):e14468. doi: 10.2196/14468.
PubMed 31793896Ito N, Sigurethsson HB, Pohlig RT, Cortes DH, Gravare Silbernagel K, Sprague AL. Reliability of Continuous Shear Wave Elastography in the Pathological Patellar Tendon. J Ultrasound Med. 2023 May;42(5):1047-1055. doi: 10.1002/jum.16115. Epub 2022 Oct 27.
PubMed 36301665Abat F, Alfredson H, Cucchiarini M, Madry H, Marmotti A, Mouton C, Oliveira JM, Pereira H, Peretti GM, Spang C, Stephen J, van Bergen CJA, de Girolamo L. Current trends in tendinopathy: consensus of the ESSKA basic science committee. Part II: treatment options. J Exp Orthop. 2018 Sep 24;5(1):38. doi: 10.1186/s40634-018-0145-5.
PubMed 30251203Asensio-Olea L, Leiros-Rodriguez R, Marques-Sanchez MP, de Carvalho FO, Maciel LYS. Efficacy of percutaneous electrolysis for the treatment of tendinopathies: A systematic review and meta-analysis. Clin Rehabil. 2023 Jun;37(6):747-759. doi: 10.1177/02692155221144272. Epub 2022 Dec 30.
PubMed 36583575Dufner A, Thomas G. Ribosomal S6 kinase signaling and the control of translation. Exp Cell Res. 1999 Nov 25;253(1):100-9. doi: 10.1006/excr.1999.4683.
PubMed 10579915Eliasson J, Elfegoun T, Nilsson J, Kohnke R, Ekblom B, Blomstrand E. Maximal lengthening contractions increase p70 S6 kinase phosphorylation in human skeletal muscle in the absence of nutritional supply. Am J Physiol Endocrinol Metab. 2006 Dec;291(6):E1197-205. doi: 10.1152/ajpendo.00141.2006. Epub 2006 Jul 11.
PubMed 16835402Lepley LK, Stoneback L, Macpherson PCD, Butterfield TA. Eccentric Exercise as a Potent Prescription for Muscle Weakness After Joint Injury. Exerc Sport Sci Rev. 2023 Jul 1;51(3):109-116. doi: 10.1249/JES.0000000000000319. Epub 2023 Apr 24.
PubMed 37093645Penin-Franch A, Garcia-Vidal JA, Martinez CM, Escolar-Reina P, Martinez-Ojeda RM, Gomez AI, Bueno JM, Minaya-Munoz F, Valera-Garrido F, Medina-Mirapeix F, Pelegrin P. Galvanic current activates the NLRP3 inflammasome to promote Type I collagen production in tendon. Elife. 2022 Feb 24;11:e73675. doi: 10.7554/eLife.73675.
PubMed 35199642Muaidi QI. Rehabilitation of patellar tendinopathy. J Musculoskelet Neuronal Interact. 2020 Dec 1;20(4):535-540.
PubMed 33265081Riel H, Lindstrom CF, Rathleff MS, Jensen MB, Olesen JL. Prevalence and incidence rate of lower-extremity tendinopathies in a Danish general practice: a registry-based study. BMC Musculoskelet Disord. 2019 May 22;20(1):239. doi: 10.1186/s12891-019-2629-6.
PubMed 31113484
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06939491
- Acronym / sponsor ID
- 898
- Conditions
- Patellar Tendinopathy / Jumpers Knee
- Keywords
- patellar tendinopathy, jumpers knee, ultra-sound-guided-electrolysis, electrolysis, galvanic current, USGET
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Gymna UniphyIndustry (pharma, biotech, devices)
- Collaborators
- Paracelsus Klinik Bremen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided galvanic electrolysis (USGET) | Experimental | Device: Ultrasound guided electrolysis therapyThe 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 |
| Sham Electrolysis | Sham comparator | Device: Sham ElectrolysisThe 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided electrolysis therapyAlso: USGETUltrasound-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. | Device | Ultrasound-guided galvanic electrolysis (USGET) |
| Sham ElectrolysisAlso: Sham TreatmentThe same intervention as the electrolysis group with the device turned on but the current intensity turned to 0 mA (e.g., no galvanic current). | Device | Sham Electrolysis |
Primary outcome
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.
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.
16 secondary outcomes
Tegner Activity Scale
Time frame: Change from baseline to the end of treatment at 10 weeks
Tegner Activity Scale
Time frame: Change from baseline to 7 months follow-up
Visa-P
Time frame: Change from baseline to the end of treatment at 10 weeks
Visa-P
Time frame: 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
International Knee Documentation Committee score
Time frame: 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
Comprehensive Aachen Knee Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 7 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 28960372Risch L, Wochatz M, Messerschmidt J, Engel T, Mayer F, Cassel M. Reliability of Evaluating Achilles Tendon Vascularization Assessed With Doppler Ultrasound Advanced Dynamic Flow. J Ultrasound Med. 2018 Mar;37(3):737-744. doi: 10.1002/jum.14414. Epub 2017 Sep 28.
- Background: PubMed 34461387Krott NL, Wild M, Betsch M. The Comprehensive Aachen Knee Score: Development and validation of a new patient-reported outcome measure for patellofemoral pathologies. Knee. 2021 Oct;32:112-120. doi: 10.1016/j.knee.2021.08.010. Epub 2021 Aug 27.
- Background: PubMed 17888709Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
- Background: PubMed 23012320Hernandez-Sanchez S, Hidalgo MD, Gomez A. Responsiveness of the VISA-P scale for patellar tendinopathy in athletes. Br J Sports Med. 2014 Mar;48(6):453-7. doi: 10.1136/bjsports-2012-091163. Epub 2012 Sep 25.
- Background: PubMed 4028566Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
- Background: PubMed 31793896Larrivee S, Balg F, Leonard G, Bedard S, Tousignant M, Boissy P. Wrist-Based Accelerometers and Visual Analog Scales as Outcome Measures for Shoulder Activity During Daily Living in Patients With Rotator Cuff Tendinopathy: Instrument Validation Study. JMIR Rehabil Assist Technol. 2019 Dec 3;6(2):e14468. doi: 10.2196/14468.
- Background: PubMed 36301665Ito N, Sigurethsson HB, Pohlig RT, Cortes DH, Gravare Silbernagel K, Sprague AL. Reliability of Continuous Shear Wave Elastography in the Pathological Patellar Tendon. J Ultrasound Med. 2023 May;42(5):1047-1055. doi: 10.1002/jum.16115. Epub 2022 Oct 27.
- Background: PubMed 30251203Abat F, Alfredson H, Cucchiarini M, Madry H, Marmotti A, Mouton C, Oliveira JM, Pereira H, Peretti GM, Spang C, Stephen J, van Bergen CJA, de Girolamo L. Current trends in tendinopathy: consensus of the ESSKA basic science committee. Part II: treatment options. J Exp Orthop. 2018 Sep 24;5(1):38. doi: 10.1186/s40634-018-0145-5.
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- The Acure 8000 is the device used for the ultrasound-guided-electrolysis therapyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided electrolysis therapy in people with Patellar Tendinopathy / Jumpers Knee, run by Gymna Uniphy at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Change from baseline to the end of treatment at 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06939491, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.