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Идёт набор NCT07243327

ESWT vs Conventional Physical Therapy in Greater Trochanteric Pain Syndrome

Без фазы С лечением Greater Trochanteric Pain Syndrome

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: Extracorporeal Shockwave Therapy (ESWT), TENS; Hot Pack; Ultrasound.
Кому может быть актуально
Состояния в реестре: Greater Trochanteric Pain Syndrome. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

A Prospective Randomized Controlled Trial Comparing the Effectiveness of Extracorporeal Shockwave Therapy and Conventional Physical Therapy in Patients With Greater Trochanteric Pain Syndrome

Обзор

This study aims to compare the effectiveness of Extracorporeal Shockwave Therapy (ESWT) with conventional physical therapy in patients with Greater Trochanteric Pain Syndrome (GTPS). GTPS is a common cause of lateral hip pain, often related to gluteal tendinopathy rather than trochanteric bursitis. Sixty patients will be randomly assigned to two groups: ESWT or conventional physical therapy (TENS, hot pack, ultrasound). Pain (VAS), hip function (Harris Hip Score), lower limb function (LEFS), and global improvement will be evaluated at baseline, week 3, and week 12. The purpose of this study is to determine which treatment provides greater pain relief and functional improvement.

Подробное описание

Greater Trochanteric Pain Syndrome (GTPS) is a frequent cause of lateral hip pain and is now understood to be primarily associated with gluteus medius and minimus tendinopathy rather than inflammation of the trochanteric bursa. Although several conservative treatments are available, including nonsteroidal anti-inflammatory drugs and physical therapy modalities, there is no consensus on the most effective treatment strategy. Extracorporeal Shockwave Therapy (ESWT) has emerged as a potential non-invasive treatment option that may promote tissue regeneration, reduce pain, and improve tendon healing.

This prospective randomized controlled trial will include 60 patients aged 18-65 years with MRI-confirmed GTPS. Participants will be randomly assigned (1:1) to either the ESWT group or the conventional physical therapy group. The ESWT group will receive five sessions over 3 weeks (15 Hz, 3 bar, 2000 pulses). The physical therapy group will receive 10 sessions of TENS (20 minutes), hot pack (20 minutes), and continuous ultrasound (1.5 W/cm², 5 minutes). Both groups will be given a standardized exercise program.

Outcome measures include the Visual Analog Scale (VAS) for pain (night, rest, activity), Harris Hip Score, Lower Extremity Functional Scale (LEFS), and the Global Rating of Change Scale. Assessments will be performed at baseline, week 3, and week 12. The primary objective is to compare the effect of ESWT versus conventional physical therapy on pain reduction. Secondary objectives include evaluating functional improvements and global patient satisfaction.

Вмешательства

  • Устройство Extracorporeal Shockwave Therapy (ESWT)
    ESWT applied with Elmed Vibrolith Ortho device at 15 Hz, 3 bar, 2000 pulses, 5 sessions over 3 weeks.
  • Другое TENS; Hot Pack; Ultrasound
    10 sessions of TENS (20 min), hot pack (20 min), and continuous ultrasound (1.5 W/cm², 5 min).

Первичные конечные точки

  • Change in Visual Analog Scale (VAS) Pain Score [Срок оценки: Baseline, Week 3, and Week 12]
Вторичные конечные точки (3)
  • Harris Hip Score [Срок оценки: Baseline, Week 3, and Week 12]
  • Lower Extremity Functional Scale (LEFS) [Срок оценки: Baseline, Week 3, and Week 12]
  • Global Rating of Change (GROC) [Срок оценки: Week 3 and Week 12]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Lateral hip pain for at least 3 months
  • Ability to understand study procedures and provide informed consent

Критерии исключения

  • Hip deformities
  • Gluteus medius, gluteus minimus, or piriformis tendon tears
  • Lumbar radiculopathy or history of lumbar spine surgery
  • Recent trauma or active infection in the hip region
  • Corticosteroid injection to the hip within the last 6 months
  • Neurological, psychiatric, or rheumatologic diseases
  • Active malignancy or systemic inflammatory disease
  • Cognitive impairment preventing cooperation

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

Turkey (Türkiye) · 1 центр
  • Kanuni Sultan Süleyman Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07243327 · BTAS-ESWT-2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗