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Набор скоро начнётся NCT07656441

Mobilization With Movement in Rotator Cuff Tendinopathy

Без фазы С лечением Rotator Cuff 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: Exercise Therapy, Mobilization With Movement (MWM).
Кому может быть актуально
Состояния в реестре: Rotator Cuff 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Mobilization With Movement on Tendon Morphology, Pain, and Function in Patients With Rotator Cuff Tendinopathy: A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to investigate the effects of Mobilization With Movement (MWM) combined with exercise therapy on tendon morphology, pain, and functional outcomes in individuals with rotator cuff tendinopathy. A total of approximately 60 participants diagnosed with supraspinatus tendinopathy will be randomly assigned to either an exercise-only group or an exercise plus MWM group. All participants will undergo a standardized rehabilitation program for 8 weeks. Clinical outcomes, including pain intensity (Visual Analog Scale), shoulder function (SPADI and QuickDASH), range of motion, muscle strength, proprioception, and psychosocial status (Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, and Central Sensitization Inventory), will be assessed at baseline and post-intervention. In addition, ultrasound imaging will be used to evaluate tendon morphology, including tendon thickness, subacromial bursa thickness, acromiohumeral distance, echogenicity, and vascularity. The primary objective is to determine whether MWM produces superior improvements in clinical outcomes and whether it is associated with measurable changes in tendon structure as assessed by ultrasound. The findings are expected to contribute to a better understanding of the biomechanical and neurophysiological mechanisms underlying manual therapy in rotator cuff tendinopathy and to provide evidence for its role in musculoskeletal rehabilitation.

Подробное описание

Rotator cuff tendinopathy is one of the most common causes of shoulder pain and functional limitation, often resulting in reduced quality of life and impaired upper extremity performance. Although exercise therapy is widely accepted as the cornerstone of conservative management, the additional benefit of manual therapy techniques, particularly Mobilization With Movement (MWM), remains an area of ongoing investigation. Furthermore, the potential effects of manual therapy on tendon morphology assessed via ultrasound imaging are not yet fully understood.

This randomized controlled trial will examine whether the addition of MWM to a standardized exercise program provides superior outcomes compared to exercise alone in individuals with supraspinatus tendinopathy. Participants will be randomly allocated into two groups: an exercise-only group and an exercise plus MWM group. Both interventions will be delivered over an 8-week period.

The study will focus on both clinical and imaging-based outcomes. Clinical outcomes include pain intensity, shoulder function, range of motion, muscle strength, proprioception, and psychosocial factors such as fear of movement, pain catastrophizing, and central sensitization. Imaging outcomes will be assessed using musculoskeletal ultrasound to evaluate tendon thickness, subacromial bursa thickness, acromiohumeral distance, echogenicity, and vascularity.

The primary aim is to determine whether MWM induces superior improvements in pain and function and whether these changes are accompanied by measurable alterations in tendon morphology. Secondary aims include exploring the relationship between ultrasound-based structural changes and clinical outcomes, as well as evaluating the potential role of psychosocial factors in treatment response.

This study is expected to provide new evidence regarding the structural and functional effects of manual therapy in rotator cuff tendinopathy and to clarify whether improvements in clinical symptoms are associated with objective changes in tendon morphology.

Вмешательства

  • Поведенческое Exercise Therapy
    A standardized physiotherapy program including rotator cuff strengthening exercises, scapular stabilization exercises, posterior capsule stretching, pectoralis minor stretching, and active range of motion exercises for the shoulder.3 sessions per week for 8 weeks (supervised and/or home-based depending on protocol design)
  • Процедура Mobilization With Movement (MWM)
    Glenohumeral joint Mobilization With Movement techniques (Mulligan concept), including posterior glide and inferior glide techniques applied during active shoulder movement, aimed at improving pain-free range of motion and function. Application Details: Grade: Sustained glide during active movement Techniques: Posterior glide, inferior glide Dosage: 2 sessions per week for 8 weeks Performed by licensed physiotherapist

Первичные конечные точки

  • Supraspinatus Tendon Thickness [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
Вторичные конечные точки (9)
  • Pain Intensity [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Shoulder Pain and Disability Index (SPADI) [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • QuickDASH Score [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Shoulder Range of Motion (ROM) [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Shoulder Muscle Strength [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Joint Position Sense (JPS) [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Tampa Scale of Kinesiophobia (TSK) [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Central Sensitization Inventory (CSI) [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Clinical diagnosis of rotator cuff tendinopathy (supraspinatus involvement) confirmed by musculoskeletal ultrasound
  • Shoulder pain duration of at least 3 months
  • Pain intensity ≥ 3/10 on the Visual Analog Scale (VAS)
  • Ability to understand and follow instructions and complete questionnaires

Критерии исключения

  • Full-thickness or large rotator cuff tear confirmed by ultrasound or MRI
  • History of shoulder surgery on the affected side
  • Diagnosis of adhesive capsulitis (frozen shoulder)
  • Shoulder instability or dislocation history
  • Cervical radiculopathy or referred neck-related shoulder pain
  • Inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis)
  • Neurological disorders affecting upper extremity function
  • Corticosteroid injection in the shoulder within the last 6 months
  • Ongoing physiotherapy or manual therapy treatment for shoulder pain in the last 3 months
  • Severe systemic or psychiatric conditions that may interfere with participation

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07656441 · KAEÜFTR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗