Capsular Distension Versus Corticosteroid Injection in Patients With Adhesive Capsulitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Shoulder Pain Intensity (Visual Analog Scale)
研究概览
简要总结
Adhesive capsulitis is a common and disabling shoulder condition characterized by pain and progressive limitation of range of motion. Capsular distension and intra-articular corticosteroid injection are commonly used therapeutic options, often combined with rehabilitation, but their comparative effectiveness remains debated.
The objective of this randomized controlled trial is to compare the efficacy and tolerance of ultrasound-guided capsular distension combined with rehabilitation versus intra-articular corticosteroid injection combined with rehabilitation in patients with adhesive capsulitis.
Outcomes will include shoulder pain, range of motion, functional disability, patient satisfaction, and procedure-related complications, assessed at short, mid, and long-term follow-up.
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
- Double (Participant, Outcomes Assessor)
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 between 18 and 80 years
- •Ability to provide informed consent
- •Shoulder pain with Visual Analog Scale (VAS) ≥ 40/100
- •Limitation of external rotation < 45° or < 50% compared to the contralateral side
- •Clinically diagnosed adhesive capsulitis with normal shoulder radiography
排除标准
- •Rotator cuff tear
- •Previous shoulder surgery
- •Cervico-brachial neuralgia
- •Pregnancy or breastfeeding
- •Poorly controlled diabetes
- •Coagulation disorders or anticoagulant therapy with INR > 3
- •Allergy to lidocaine
- •Inflammatory rheumatic diseases
- •Severe cardiovascular or hematological diseases
- •Active infection or immunodeficiency
- •Severe psychiatric disorders
- •Recent shoulder rehabilitation (within 1 week)
- •Intra-articular corticosteroid injection or hyaluronic acid injection within the last 6 months
- •Refusal to sign informed consent
研究组 & 干预措施
Capsular Distension
Ultrasound-guided capsular distension with immediate mobilization followed by a standardized rehabilitation program.
干预措施: capsular distension (Procedure)
Betamethasone (Diprostene®) injection
Ultrasound-guided intra-articular injection of betamethasone (Diprostene®) into the glenohumeral joint, performed under sterile conditions, followed by a standardized rehabilitation program.
干预措施: Betamethasone (Diprostene®) Injection (Procedure)
结局指标
主要结局
Shoulder Pain Intensity (Visual Analog Scale)
时间窗: Baseline, 1 month, 3 months, and 6 months
Change in shoulder pain intensity assessed using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain.
Shoulder range of motion
时间窗: Baseline, 1 month, 3 months, and 6 months
Change in active shoulder range of motion measured in degrees, including external rotation, internal rotation, abduction, and forward elevation.
Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline, 1 month, 3 months, and 6 months
Change in shoulder pain and disability assessed using the Shoulder Pain and Disability Index (SPADI), a validated 13-item questionnaire scored from 0 to 100, with higher scores indicating greater pain and disability.
次要结局
- Patient Satisfaction Score(6 months)
- Procedure-Related Complications(1 month)
- Rotator Cuff Interval Doppler Signal(Inclusion, 3 months ,6 months)
- Coracohumeral Ligament Thickness(Baseline, 3 months, and 6 months)
- Glenohumeral Capsular Thickness(Baseline, 3 months, and 6 months)