Efficacy of the Extracorporeal Shock Wave Therapy in Athletes With Patellar Tendinopathy

Обзор

The aim of this study is to investigate the effectiveness of extracorporeal shock wave therapy (ESWT) in addition to eccentric exercise on the clinical outcomes of PT in the treatment of athletes with patellar tendinopathy (PT). Participants will be randomly divided into two groups. The intervention group will receive focus ESWT 3 times a week in addition to 6 weeks of exercise. The control group will be given 6 weeks of exercise. Evaluations will be made at the 3rd and 6th weeks, and at the 3rd, 6th and 12th months. Patient evaluation will begin with obtaining sociodemographic information. Patients' pain level will be assessed using visual analog scale (VAS), tendon pain and function VISA-P, functional capacity; The patients will be assessed with the maximal vertical jump test (MDS), single leg jump distance test (SLHD), single leg squat test (STS) on the incline board, pain catastrophe with the pain catastrophe scale (PCS), kinesiophobia with the Tampa Kinesiophobia Scale (TKS), quality of life short form-12 (SF-12) and physical activity level with the Tegner Activity Scale (TAS).

Вмешательства

• Другое Eccentric exercise program (EEP)
  All participants will perform a 6-week single-leg eccentric squat exercise. It will be performed on an incline board with a 25° incline. It will consist of a single-leg squat, with the downward component (eccentric phase) of the EEP performed using the symptomatic leg and the upward component (concentric phase) using the contralateral leg primarily. If pain occurs during the exercises, athletes will be asked to continue the exercise if they score ≤5 out of 10 on the Visual Acuity Scale (VAS). Th
• Другое ESWT (Extracorporeal Shock Wave Therapy)
  ESWT is a therapy method routinely used in private and public hospitals. Tendinopathy therapy parameters approved by the International Society for Medical Shock Wave Therapy (ISMST) for focused ESWT treatment are: 0.10-0.25 mJ/mm (dosing appropriate to pain), up to a maximum of 5 Hz, 1500-2500 pulses per session, 1-2 weeks apart. Accordingly, in our study, the focused ESWT dosage of the ESWT group will be applied as; 0.10-0.25 mJ/mm (dosing appropriate to pain), 4 Hz, 2000 pulses, 1 session per

Первичные конечные точки

• Sociodemographic Assessment [Срок оценки: Baseline]
• Visual Analog Scale (VAS) [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• VISA-P Questionnaire [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Maximal vertical jump test [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Single-leg hop distance test (SLHD) [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Incline board single-leg squat test (EET) [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]

Вторичные конечные точки (4)

• Tegner Activity Scale (TAS) [Срок оценки: Baseline]
• Pain Catastrophizing Scale [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Tampa Kinesiophobia Scale [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Quality of Life (SF-12) [Срок оценки: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]

Критерии участия

Критерии включения

• Localized pain in the inferior pole of the patella during single-leg squatting due to load,
• Pain or tenderness with palpation of the patellar tendon,
• Complaints of pain in the patellar tendon due to training, competition or physical activity in the last 6 months,
• Performing sports/physical activities related to jumping and landing,
• Professional and recreational athletes who perform at least 5 and above according to the Tegner Activity score,
• VISA-P scale score <80 out of 100.

Критерии исключения

• Presence of other knee pathologies,
• Known presence of inflammatory joint diseases or familial hypercholesterolemia,
• Daily use of drugs with presumed effects on the patellar tendon (e.g. fluoroquinolones) in the last 12 months,
• Local injection therapy with corticosteroids in the last 12 months,
• Previous patellar tendon rupture,
• Any lower extremity surgery in the last 6 months.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ahi Evran University — Kırşehir

Публикации

• Breda SJ, Oei EHG, Zwerver J, Visser E, Waarsing E, Krestin GP, de Vos RJ. Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial. Br J Sports Med. 2021 May;55(9):501-509. doi: 10.1136/bjsports-2020-103403. Epub 2020 Nov 20. PMID 33219115

Идентификаторы

NCT: NCT06705881 · 2024/1012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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