跳至主要内容
临床试验/NCT07383038
NCT07383038招募中不适用

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

Kirsehir Ahi Evran Universitesi1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年8月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
Quick Disabilities of the Arm, Shoulder and Hand questionnaire.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

This study will be conducted using a single-blind design. Due to the nature of the manual therapy interventions, it is not feasible to blind participants or treating physiotherapists to group allocation. However, the outcome assessor will be blinded to the participants' group assignments in order to minimize measurement and assessment bias.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Conventional Physiotherapy Group

Active Comparator

Participants in this arm will receive a conventional physiotherapy program commonly used in the conservative management of rotator cuff lesions. The program will include therapeutic exercises, stretching, and physical therapy modalities aimed at reducing pain and improving shoulder function. Mobilization with Movement or other Mulligan-based manual therapy techniques will not be applied in this group.

干预措施: Conventional Physiotherapy (Other)

Mobilization with Movement (MWM) Group

Experimental

Participants allocated to this arm will receive Mobilization with Movement interventions based on the Mulligan concept. The technique will involve the application of sustained accessory glenohumeral joint mobilization combined with active, pain-free shoulder movements. Interventions will be administered by a trained physiotherapist according to a standardized protocol. This group may also receive basic conventional physiotherapy components excluding other manual mobilization techniques.

干预措施: Mulligan mobilization (Other)

结局指标

主要结局

Quick Disabilities of the Arm, Shoulder and Hand questionnaire.

时间窗: Baseline (pre-intervention) and at the end of the 8-week intervention period.

Upper Extremity Functional Disability, Higher scores better outcomes

次要结局

  • Visual Analog Scale(Baseline (pre-intervention) and at the end of the 8-week intervention period.)
  • Joint Position Sense Error (cm)(Baseline (pre-intervention) and at the end of the 8-week intervention period.)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ömer Faruk ÖZÇELEP

Dr

Kirsehir Ahi Evran Universitesi

研究点 (1)

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