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Идёт набор NCT07383038

Effect of Mobilization With Movement in Patients With Rotator Cuff Lesions

Без фазы С лечением Rotator Cuff Tears Physical Disability

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: Mulligan mobilization, Conventional Physiotherapy.
Кому может быть актуально
Состояния в реестре: Rotator Cuff Tears, Physical Disability. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Mobilization With Movement on Function, Disability, and Pain in Patients With Rotator Cuff Lesions: A Double-Blind Randomized Controlled Trial

Обзор

This randomized controlled trial aims to investigate the effects of Mobilization with Movement (MWM) on pain and functional status in individuals with rotator cuff lesions. Rotator cuff pathology is a common cause of shoulder pain and functional limitation, and impairments in proprioception may further compromise shoulder motor control and recovery. Eligible participants with rotator cuff lesions will be randomly allocated into three groups: (1) Mobilization with Movement (MWM), (2) conventional physiotherapy, and (3) control group. All participants will be evaluated before and after the intervention period. Outcome measures will include shoulder-related functional disability assessed by the QuickDASH questionnaire, pain intensity, and shoulder joint position sense evaluated using an active repositioning test with a laser pointer during shoulder flexion. The study is designed to determine whether MWM provides additional benefits over conventional treatment or task oriented training intervention in improving pain, function, and proprioceptive accuracy. The findings are expected to contribute to evidence-based conservative rehabilitation strategies for patients with rotator cuff lesions.

Подробное описание

Rotator cuff lesions are among the most common causes of shoulder pain and functional limitation, particularly in middle-aged and older adults. Due to the wide range of motion and complex biomechanics of the glenohumeral joint, integrity of the rotator cuff muscles is essential for dynamic stability, coordinated movement, and precise joint positioning. Pathological changes in the rotator cuff may lead not only to pain and reduced functional capacity but also to impairments in proprioception, which can negatively affect motor control and increase the risk of recurrent injury.

Conservative management is widely recommended as the first-line treatment for rotator cuff lesions and typically includes therapeutic exercises, physical agents, and manual therapy techniques. Mobilization with Movement (MWM), developed within the Mulligan concept, is a manual therapy approach that combines sustained accessory joint mobilization with active, pain-free physiological movement. MWM is proposed to improve joint mechanics, reduce pain, and enhance neuromuscular and proprioceptive input. While previous studies have demonstrated the effectiveness of MWM in reducing pain and improving function in various musculoskeletal conditions, evidence regarding its effects on shoulder proprioception, particularly joint position sense, in individuals with rotator cuff lesions remains limited.

This randomized controlled trial is designed to evaluate the effects of MWM on pain, functional outcomes, and joint position sense in patients with rotator cuff lesions. Eligible participants diagnosed with rotator cuff pathology will be randomly assigned to one of three groups: (1) Mobilization with Movement (MWM) group, (2) conventional physiotherapy group, or (3) task oriented training group. Randomization will be performed after baseline assessment to ensure allocation concealment.

All participants will undergo standardized assessments at baseline (pre-intervention) and after completion of the intervention period (post-intervention). Functional status of the upper extremity will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Pain intensity will be assessed using validated self-report measures. Shoulder proprioception will be assessed through a joint position sense test using an active repositioning method during shoulder flexion with a laser pointer system, recording the deviation from a predefined target point in centimeters.

The MWM group will receive manual therapy interventions based on Mulligan principles, applied by a trained physiotherapist, in addition to standard care. The conventional physiotherapy group will receive commonly used rehabilitation interventions excluding MWM techniques. The control group will not receive therapeutic intervention during the study period. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all participants prior to enrollment.

The primary objective of this study is to determine whether MWM leads to superior improvements in pain, functional ability, and joint position sense compared with conventional physiotherapy and no intervention. Secondary objectives include evaluating the magnitude of treatment effects and exploring the relationship between changes in proprioception and functional outcomes. The results of this trial are expected to provide clinically relevant evidence regarding the role of Mobilization with Movement in conservative rehabilitation protocols for individuals with rotator cuff lesions.

Вмешательства

  • Другое Mulligan mobilization
    Participants assigned to the Mobilization with Movement (MWM) group will receive manual therapy based on the Mulligan concept. The intervention will consist of the application of sustained, pain-free accessory mobilization to the glenohumeral joint combined with active physiological shoulder movements, primarily in shoulder flexion and abduction. The direction and grade of mobilization will be individually determined according to the patient's symptoms and movement restrictions, ensuring that al
  • Другое Conventional Physiotherapy
    Participants allocated to the conventional physiotherapy group will receive a standard rehabilitation program commonly used for rotator cuff lesions. The intervention will include therapeutic exercises targeting shoulder range of motion, strengthening of the rotator cuff and scapular stabilizing muscles, and stretching exercises for periarticular soft tissues. Physical therapy modalities such as heat or ultrasound may be applied as needed for pain management. This intervention will be delivered

Первичные конечные точки

  • Quick Disabilities of the Arm, Shoulder and Hand questionnaire. [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period.]
Вторичные конечные точки (2)
  • Visual Analog Scale [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period.]
  • Joint Position Sense Error (cm) [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period.]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Clinical and/or imaging-confirmed diagnosis of rotator cuff lesion (e.g., tendinopathy or partial tear)
  • Presence of shoulder pain for at least 3 months
  • Pain and functional limitation during shoulder movements
  • Ability to actively perform shoulder movements required for assessment and intervention
  • No physiotherapy or manual therapy treatment for the affected shoulder within the last 3 months

Критерии исключения

  • History of shoulder surgery on the affected side
  • Full-thickness rotator cuff tear or shoulder instability
  • Shoulder fracture, dislocation, or acute trauma within the past 6 months
  • Neurological disorders affecting the upper extremity (e.g., cervical radiculopathy, peripheral neuropathy)
  • Systemic inflammatory or rheumatologic diseases
  • Severe shoulder osteoarthritis or adhesive capsulitis
  • Current participation in another clinical trial
  • Use of corticosteroid injection in the affected shoulder within the last 3 months
  • Pregnancy
  • Inability to comply with the study protocol or assessment procedures

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

  • Ozlu O, Sahin M. The effect of mulligan mobilization technique application in addition to conventional physiotherapy on pain and joint range of motion in people with neck pain. J Bodyw Mov Ther. 2024 Jul;39:225-230. doi: 10.1016/j.jbmt.2024.02.009. Epub 2024 Mar 5. PMID 38876630

Идентификаторы

NCT: NCT07383038 · AEU-FTR3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗