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

NCT06939491 | Enrolling By Invitation

• 1 other identifier: 898
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinopathy / Jumpers Knee

Keywords

patellar tendinopathy; jumpers knee; ultra-sound-guided-electrolysis; electrolysis; galvanic current; USGET

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from baseline to 7 months follow-up

Secondary Outcomes (16)

• Tegner Activity Scale

  Change from baseline to the end of treatment at 10 weeks

• Tegner Activity Scale

  Change from baseline to 7 months follow-up

• Visa-P

  Change from baseline to the end of treatment at 10 weeks

• Visa-P

  Change from baseline to 7 months follow-up

• International Knee Documentation Committee score

  Change from baseline to the end of treatment at 10 weeks

Study Arms (2)

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

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.

Device: Sham Electrolysis

Interventions

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.

Also known as: USGET

Ultrasound-guided galvanic electrolysis (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).

Also known as: Sham Treatment

Sham Electrolysis

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gymna Uniphy: lead
• Paracelsus Klinik Bremen: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator

Study Sites (1)

Paracelsus Sportmedizin & Prävention Bremen

Bremen, City state Bremen, 28205, Germany

Location

Related Publications (21)

• 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.

  PMID: 28960372 BACKGROUND

• Krott 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.

  PMID: 34461387 BACKGROUND

• Higgins 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.

  PMID: 17888709 BACKGROUND

• Hernandez-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.

  PMID: 23012320 BACKGROUND

• Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.

  PMID: 4028566 BACKGROUND

• Larrivee 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.

  PMID: 31793896 BACKGROUND

• Ito 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.

  PMID: 36301665 BACKGROUND

• Abat 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.

  PMID: 30251203 BACKGROUND

• Asensio-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.

  PMID: 36583575 BACKGROUND

• Dufner 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.

  PMID: 10579915 BACKGROUND

• Eliasson 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.

  PMID: 16835402 BACKGROUND

• Lepley 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.

  PMID: 37093645 BACKGROUND

• Penin-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.

  PMID: 35199642 BACKGROUND

• Muaidi QI. Rehabilitation of patellar tendinopathy. J Musculoskelet Neuronal Interact. 2020 Dec 1;20(4):535-540.

  PMID: 33265081 BACKGROUND

• Riel 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.

  PMID: 31113484 BACKGROUND

• Lian OB, Engebretsen L, Bahr R. Prevalence of jumper's knee among elite athletes from different sports: a cross-sectional study. Am J Sports Med. 2005 Apr;33(4):561-7. doi: 10.1177/0363546504270454. Epub 2005 Feb 8.

  PMID: 15722279 BACKGROUND

• Kujala UM, Sarna S, Kaprio J. Cumulative incidence of achilles tendon rupture and tendinopathy in male former elite athletes. Clin J Sport Med. 2005 May;15(3):133-5. doi: 10.1097/01.jsm.0000165347.55638.23.

  PMID: 15867554 BACKGROUND

• Hopkins C, Fu SC, Chua E, Hu X, Rolf C, Mattila VM, Qin L, Yung PS, Chan KM. Critical review on the socio-economic impact of tendinopathy. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2016 Apr 22;4:9-20. doi: 10.1016/j.asmart.2016.01.002. eCollection 2016 Apr.

  PMID: 29264258 BACKGROUND

• Graca AL, Gomez-Florit M, Gomes ME, Docheva D. Tendon Aging. Subcell Biochem. 2023;103:121-147. doi: 10.1007/978-3-031-26576-1_7.

  PMID: 37120467 BACKGROUND

• Mirghaderi SP, Valizadeh Z, Shadman K, Lafosse T, Oryadi-Zanjani L, Yekaninejad MS, Nabian MH. Cell therapy efficacy and safety in treating tendon disorders: a systemic review of clinical studies. J Exp Orthop. 2022 Aug 30;9(1):85. doi: 10.1186/s40634-022-00520-9.

  PMID: 36042110 BACKGROUND

• Abat F, Sanchez-Sanchez JL, Martin-Nogueras AM, Calvo-Arenillas JI, Yajeya J, Mendez-Sanchez R, Monllau JC, Gelber PE. Randomized controlled trial comparing the effectiveness of the ultrasound-guided galvanic electrolysis technique (USGET) versus conventional electro-physiotherapeutic treatment on patellar tendinopathy. J Exp Orthop. 2016 Dec;3(1):34. doi: 10.1186/s40634-016-0070-4. Epub 2016 Nov 16.

  PMID: 27854082 BACKGROUND

Related Links

• The Acure 8000 is the device used for the ultrasound-guided-electrolysis therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: October 29, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 01.08.2026 until 31.12.2026

Locations

DE (1)