The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pain Intensity (Numeric Rating Scale, NRS)
研究概览
简要总结
Massive rotator cuff tears are associated with significant pain, functional limitations, and prolonged rehabilitation following surgical repair. In the early postoperative phase, rehabilitation protocols are often limited due to surgical protection requirements, which may delay the restoration of motor control and shoulder function. Graded motor imagery (GMI), a movement representation technique that includes laterality recognition, motor imagery, and mirror therapy, has been shown to modulate cortical processing and improve pain and motor function in various musculoskeletal and neurological conditions. However, its potential role in early postoperative shoulder rehabilitation has not been adequately investigated.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 65 years
- •Presence of an arthroscopically repaired anterior-superior rotator cuff tear, involving the supraspinatus and subscapularis tendons
排除标准
- •Age younger than 30 years or older than 65 years
- •Presence of severe malignant, hematological, endocrine, metabolic, rheumatologic, or gastrointestinal diseases
- •Diagnosis of glenohumeral osteoarthritis (Kellgren-Lawrence grade III or higher, with radiographic evidence of osteophytes)
- •Current treatment with cytotoxic agents or systemic corticosteroids
- •Alcohol dependence, history of substance abuse, or psychological/emotional disorders that may compromise the validity of informed consent
- •Previous surgery on the ipsilateral shoulder
- •Multiple tendon tears, such as combined tears involving the supraspinatus together with the infraspinatus or subscapularis tendons
结局指标
主要结局
Pain Intensity (Numeric Rating Scale, NRS)
时间窗: Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks after surgery.
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where participants rate their average shoulder pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst imaginable pain). Pain will be evaluated at rest, during activity, and at night.
Subjective Shoulder Value (SSV)
时间窗: Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks.
Participants will rate the overall function of their shoulder on a 10-cm scale ranging from "as bad as it could be" to "as good as it could be."
Passive Shoulder Range of Motion
时间窗: 4 weeks, 6 weeks, and 12 weeks after surgery.
Passive shoulder range of motion will be measured using a goniometer.
次要结局
- Shoulder Pain and Disability Index (SPADI)(6 weeks and 12 weeks after surgery.)
- Motor Imagery Ability (VMIQ-2)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)
- Tampa Scale of Kinesiophobia (TSK)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)
- Pain Catastrophizing Scale (PCS)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline (postoperative day 0), 6 weeks, and 12 weeks.)
研究者
Nuray Alaca
Assoc. Prof. Nuray Alaca
Acibadem University