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Идёт набор NCT07094178

Corticosteroid Versus PRP Injections for Shoulder Tendinopathy

Без фазы С лечением Tendinopathy of Rotator Cuff

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: Corticosteroid Injection, platelet-rich plasma injection.
Кому может быть актуально
Состояния в реестре: Tendinopathy of Rotator Cuff. Базовые параметры: от 18 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
Tunisia
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Corticosteroid Versus Platelet-Rich Plasma Injections in the Treatment of Shoulder Tendinopathy: A Randomized Controlled Trial

Обзор

Shoulder tendinopathy is a common condition that causes shoulder pain and limits daily activities. It often results from damage or overuse of the rotator cuff tendons. Treatment typically includes rest, physical therapy, anti-inflammatory medications, and sometimes injections. This clinical trial aims to compare the effectiveness of two types of injections for treating simple shoulder tendinopathy: Corticosteroid injections, which reduce inflammation and provide quick pain relief, but may have only short-term effects. Platelet-Rich Plasma (PRP) injections, a newer treatment made from the patient's own blood, which may promote long-term healing. The study is being conducted at the Rheumatology Department of Charles Nicolle Hospital in Tunis, Tunisia. A total of 60 adult patients with shoulder tendinopathy will be randomly assigned to receive either a corticosteroid injection or a PRP injection. Participants will be evaluated before the injection (baseline), after one week, and after three months. The researchers will assess pain levels using a visual analog scale (VAS), and shoulder function using validated questionnaires (DASH and SPADI scores). The goal is to determine which treatment provides better pain relief and functional improvement over time.

Вмешательства

  • Процедура Corticosteroid Injection
    This intervention consists of a single injection of corticosteroids administered directly into the affected tendon of the shoulder. Corticosteroids are anti-inflammatory drugs used to rapidly reduce inflammation and pain associated with tendinopathy. The injection is performed under aseptic conditions by a trained physician. The aim is to provide quick pain relief and improve shoulder function, although effects may be temporary.
  • Процедура platelet-rich plasma injection
    This intervention involves a single injection of Platelet-Rich Plasma (PRP), which is prepared from the patient's own blood through a process of centrifugation to concentrate platelets. PRP contains growth factors that may promote tissue healing and regeneration. The injection is administered under aseptic conditions into the affected shoulder tendon by a trained physician. The goal is to enhance long-term recovery of tendon function and reduce pain.

Первичные конечные точки

  • Change in pain intensity measured by Visual Analog Scale (VAS) [Срок оценки: baseline, 1 week, 3 months]
  • Change in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score [Срок оценки: baseline, 1 week and 3 months]
  • Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI) [Срок оценки: baseline, 1 week, 3 months]

Критерии участия

Критерии включения

  • Adults aged 18 years and older
  • Diagnosed with simple tendinopathy of the shoulder confirmed by clinical examination and imaging
  • Experiencing shoulder pain for at least 4 weeks
  • Able to provide informed consent

Критерии исключения

  • Previous shoulder surgery on the affected side
  • Presence of rotator cuff tear or severe shoulder pathology
  • Systemic inflammatory diseases (e.g., rheumatoid arthritis)
  • Recent corticosteroid injection in the affected shoulder (within last 3 months)
  • Contraindications to corticosteroids or PRP treatment
  • Pregnancy or breastfeeding

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
Открытое
Основная цель
Лечение

Центры проведения

Tunisia · 1 центр
  • Charles Nicolle Hospital — Tunis

Публикации

  • Bouden S, Jebali C, Ben Dhia S, Rouached L, Saidane O, Mahmoud I, Tekaya R, Ben Tekaya A, Abdelmoula L. Shoulder injection of platelet-rich plasma versus corticosteroids in rotator cuff tendinopathies. Scand J Rheumatol. 2026 Mar 18:1-8. doi: 10.1080/03009742.2026.2620888. Online ahead of print. PMID 41848176

Идентификаторы

NCT: NCT07094178 · PRP-CS-2025-CN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗