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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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,
• Устройство 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).

Первичные конечные точки

• Visual Analogue Scale (VAS) [Срок оценки: Change from baseline to the end of treatment at 10 weeks]
• Visual Analogue Scale (VAS) [Срок оценки: Change from baseline to 7 months follow-up]

Вторичные конечные точки (12)

• Tegner Activity Scale [Срок оценки: Change from baseline to the end of treatment at 10 weeks]
• Tegner Activity Scale [Срок оценки: Change from baseline to 7 months follow-up]
• Visa-P [Срок оценки: Change from baseline to the end of treatment at 10 weeks]
• Visa-P [Срок оценки: Change from baseline to 7 months follow-up]
• International Knee Documentation Committee score [Срок оценки: Change from baseline to the end of treatment at 10 weeks]
• International Knee Documentation Committee score [Срок оценки: Change from baseline to 7 months follow-up]
• Comprehensive Aachen Knee Score [Срок оценки: Change from baseline to the end of treatment at 10 weeks]
• Comprehensive Aachen Knee Score [Срок оценки: Change from baseline to 7 months follow-up]
• B-scan sonography [Срок оценки: Change from baseline to the end of treatment at 10 weeks]
• B-scan sonography [Срок оценки: Change from baseline to 7 months follow-up]
• Doppler sonography [Срок оценки: Change from baseline to the end of treatment at 10 weeks]
• Doppler sonography [Срок оценки: Change from baseline to 7 months follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Paracelsus Sportmedizin & Prävention Bremen — Bremen

Публикации

• 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
• 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
• 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
• 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
• Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9. PMID 4028566
• 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
• 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
• 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

Идентификаторы

NCT: NCT06939491 · 898

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗