Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Percutaneous needle tenotomy (PNT), Percutaneous ultrasonic tenotomy (PUT, Tenex Device).
- Кому может быть актуально
- Состояния в реестре: Tendinopathy, Tendinosis, Gluteal Tendinitis. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this study is to determine if a newer tenotomy technique utilizing an ultrasound needle is more effective than the traditional tenotomy technique utilizing a simple hypodermic needle for gluteal tendinosis. The main questions it aims to answer are: 1. Is pain from the gluteal tendinosis improved with either technique, and, if so, is there a difference in the improvement between techniques? 2. Is there an improvement in function for gluteal tendinosis, and, if so, is there a difference between techniques?
Подробное описание
Study Design This study is designed as a single-blinded, randomized control trial with two parallel arms comparing PNT vs PUT device for the treatment of gluteal (medius and minimus) tendinosis with analysis of pain, physical function, activities of daily living (ADLs) and overall health over four months. Participants will be randomly assigned (1:1) to receive PNT or PUT at one academic medical center. Each participant will be assigned a patient ID and randomized to one of the two groups. The participants and outcomes assessors will be blinded to treatment group allocation, but the physician administering treatment will not be blinded.
Вмешательства
- Процедура Percutaneous needle tenotomy (PNT)
Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis - Устройство Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis
Первичные конечные точки
- Change from baseline in pain, as measured by the Visual Analog Scale (VAS) [Срок оценки: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.]
Вторичные конечные точки (1)
- Change from baseline in physical function, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function grading scale for activities of daily living (ADLs) [Срок оценки: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.]
Критерии участия
Критерии включения
- Diagnosis of gluteal (medius and/or minimus) tendinosis confirmed clinically and with ultrasonography or MRI
- Failure to improve after 3 months of nonoperative treatment
- Symptoms present for longer than 3 months
Критерии исключения
- Patients with concomitant injuries or pain
- Full thickness tears of the affected tendon
- Prior corticosteroid injection of the affected tendon within the last 3 months
- Prior PNT of the affected tendon
- Significant abnormalities of bony or tendon morphology
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
США · 1 центр
- UCHealth CU Sports Medicine - Colorado Center — Denver
Публикации
- Yelin E, Weinstein S, King T. The burden of musculoskeletal diseases in the United States. Semin Arthritis Rheum. 2016 Dec;46(3):259-260. doi: 10.1016/j.semarthrit.2016.07.013. Epub 2016 Jul 26. No abstract available. PMID 27519477
- Millar NL, Silbernagel KG, Thorborg K, Kirwan PD, Galatz LM, Abrams GD, Murrell GAC, McInnes IB, Rodeo SA. Tendinopathy. Nat Rev Dis Primers. 2021 Jan 7;7(1):1. doi: 10.1038/s41572-020-00234-1. PMID 33414454
- Hurley ET, Mojica ES, Kanakamedala AC, Meislin RJ, Strauss EJ, Campbell KA, Alaia MJ. Quadriceps tendon has a lower re-rupture rate than hamstring tendon autograft for anterior cruciate ligament reconstruction - A meta-analysis. J ISAKOS. 2022 Apr;7(2):87-93. doi: 10.1016/j.jisako.2021.10.001. Epub 2021 Nov 17. PMID 35543668
- Zhou Y, Wang JH. PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies. Biomed Res Int. 2016;2016:9103792. doi: 10.1155/2016/9103792. Epub 2016 Aug 16. PMID 27610386
- Smallcomb M, Khandare S, Vidt ME, Simon JC. Therapeutic Ultrasound and Shockwave Therapy for Tendinopathy: A Narrative Review. Am J Phys Med Rehabil. 2022 Aug 1;101(8):801-807. doi: 10.1097/PHM.0000000000001894. Epub 2021 Oct 4. PMID 35859290
- Shomal Zadeh F, Shafiei M, Hosseini N, Alipour E, Cheung H, Chalian M. The effectiveness of percutaneous ultrasound-guided needle tenotomy compared to alternative treatments for chronic tendinopathy: a systematic review. Skeletal Radiol. 2023 May;52(5):875-888. doi: 10.1007/s00256-022-04140-3. Epub 2022 Jul 28. PMID 35896736
- Finnoff JT, Fowler SP, Lai JK, Santrach PJ, Willis EA, Sayeed YA, Smith J. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. PM R. 2011 Oct;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015. Epub 2011 Aug 26. PMID 21872551
- McShane JM, Shah VN, Nazarian LN. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow: is a corticosteroid necessary? J Ultrasound Med. 2008 Aug;27(8):1137-44. doi: 10.7863/jum.2008.27.8.1137. PMID 18645071
Идентификаторы
NCT: NCT07540806 · 25-1380