the Treatment Strategy of Partial Rotator Cuff Injury in Stiff Shoulders
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index （SPADI）
研究概览
简要总结
A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial)
详细描述
Objective: To compare the clinical and functional outcomes of early surgical intervention (arthroscopic debridement/repair and capsular release) versus an initial structured, supervised rehabilitation program with delayed surgery only for non-responders, in patients with PTRCT and shoulder stiffness.
Methods: This will be a single-center, prospective, randomized, controlled, parallel-group trial. patients will be randomized (1:1) to either:
Group A (Early Surgery): Arthroscopic surgery within 6 weeks of randomization.
Group B (Rehabilitation-First): A 6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.
Primary outcome will be the change in the American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score from baseline to 12 months. Secondary outcomes include pain (VAS), range of motion (ROM), Constant-Murley Score, Single Assessment Numeric Evaluation (SANE), and rates of conversion to surgery. Outcomes will be assessed at baseline 6 months and 6 months after surgery.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years.
- •Symptomatic shoulder pain for >2 weeks.
- •MRI-confirmed partial-thickness rotator cuff tear (>50% tendon thickness or >5mm in length).
- •Concomitant shoulder stiffness, defined as passive range of motion loss of ≥25% in at least two planes (forward flexion, abduction, external rotation, or internal rotation) compared to the contralateral side.
- •Failure of a brief (≥2 weeks) trial of conservative care (e.g., oral NSAIDs).
排除标准
- •Age< 18 or >80 years.
- •Full-thickness rotator cuff tear.
- •Previous surgery on the affected shoulder.
- •Glenohumeral osteoarthritis (Grade ≥2 Samilson-Prieto).
- •Cervical radiculopathy as a primary cause of symptoms.
- •Systemic inflammatory arthritis.
- •Neurologic disorder affecting the shoulder.
- •Contraindications to surgery or general anesthesia.
- •Inability to comply with the rehabilitation protocol.
研究组 & 干预措施
Group A (Early Surgery)
: Arthroscopic surgery within 6 weeks
干预措施: Arthroscopy (Procedure)
Group B (Rehabilitation-First)
6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.
干预措施: Drugs administration (Drug)
结局指标
主要结局
Shoulder Pain and Disability Index （SPADI）
时间窗: 6 month before surgery and 6 months after surgery
Shoulder Pain and Disability Index （SPADI） from 0-100. The lower the number, the better the functional outcomes of the patients.
次要结局
未报告次要终点