Comparison of the Effectiveness of Ultrasound-Guided Pericapsular and Intra-Articular Steroid Injections in Patients Diagnosed With Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Constant-Murley Score
研究概览
简要总结
Adhesive capsulitis is a common and disabling shoulder disorder characterized by progressive pain and restricted active and passive range of motion, leading to significant limitations in daily activities and reduced quality of life. Corticosteroid injections are widely used to relieve pain and improve shoulder function; however, the optimal injection site remains a matter of debate. While ultrasound-guided intra-articular injections are considered a standard treatment, ultrasound-guided pericapsular injections have recently emerged as a potential alternative by targeting the inflamed capsular tissues directly.
The primary objective of this study is to compare the clinical effectiveness of ultrasound-guided pericapsular corticosteroid injection with ultrasound-guided intra-articular corticosteroid injection in patients diagnosed with adhesive capsulitis. The study aims to determine whether one injection technique provides superior improvements in pain, shoulder range of motion, functional status, and patient-reported outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of unilateral adhesive capsulitis, characterized by shoulder pain and restriction of both active and passive range of motion.
排除标准
- •Secondary glenohumeral joint motion limitation due to inflammatory, degenerative, metabolic, or infectious arthritis.
- •History of cerebrovascular accident (stroke).
- •History of fracture involving the affected shoulder.
- •Presence of any neurological deficit affecting the upper extremity.
- •Previous surgery involving the affected shoulder.
- •History of shoulder trauma.
- •Pregnancy or breastfeeding.
- •Known hypersensitivity or allergic reaction to local anesthetics or corticosteroids used in the study.
- •Current use of anticoagulant therapy.
- •Active inflammatory or infectious disease.
- •Active psychiatric disorder.
- •Uncontrolled hypertension.
- •Uncontrolled diabetes mellitus.
- •Uncompensated chronic heart, liver, or renal failure.
- •Presence of vascular or malignant disease affecting the shoulder region.
结局指标
主要结局
Change in Constant-Murley Score
时间窗: Baseline, Week 1, Week 4, and Month 3
The Constant-Murley Score (CMS) is a validated, clinician-administered instrument used to assess shoulder function. It consists of four domains: pain (15 points), activities of daily living (20 points), range of motion (40 points), and muscle strength (25 points), yielding a total score ranging from 0 to 100. Higher scores indicate better shoulder function and less disability. Changes in the CMS from baseline to each follow-up visit will be used to evaluate treatment effectiveness.
Change in Numeric Rating Scale (NRS) pain score
时间窗: Baseline,1-Hour, Week 1, Week 4, and Month 3
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point patient-reported scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. Participants will rate their pain at rest, during the night, and during activity. Changes in NRS scores from baseline to each follow-up visit will be used to evaluate the effectiveness of the interventions in reducing pain.
次要结局
- Change in Shoulder Disability Questionnaire (SDQ) score(Baseline, Week 1, Week 4, and Month 3)
研究者
Bilal Kulaksiz
Dr.
Istanbul University - Cerrahpasa