Comparison of Ultrasound-Guided Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Chronic Rotator Cuff Tendinopathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The Western Ontario Rotator Cuff Index (WORC)
研究概览
简要总结
Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain.
The aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.
详细描述
Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain.
There are limited studies comparing the efficacy of ozone and corticosteroid injections in rotator cuff tendinopathy. In this context, the aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.
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)
盲法说明
Outcome measures will be evaluated by an independent physiatrist, blinded for the assigned treatment.
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
- •aged between 18 and 70 years
- •pain in the shoulder region and increase in pain with overhead-throwing activity
- •chronic shoulder pain for more than 3 months
- •partial rotator cuff tear or rotator cuff tendinosis diagnosed by US or magnetic resonance imaging (MRI).
排除标准
- •a full-thickness rotator cuff tear diagnosed by US or MRI
- •allergic reaction betamethasone or lidocaine
- •contraindications for ozone (O2-O3) injection, such as uncontrolled hyperthyroidism, glucose-6 phosphate dehydrogenase deficiency (G6PDD), pregnancy and platelet level <50 103/µL
- •history of coagulopathy, diabetes, or hepatitis
- •intra-articular/subacromial injections in the last 3 months
- •history of shoulder infection, fracture, trauma, bony lesion, tumor or inflammatory rheumatic diseases
- •history of brachial plexus lesion/cervical radiculopathy.
结局指标
主要结局
The Western Ontario Rotator Cuff Index (WORC)
时间窗: at baseline and change from baseline WORC at 4 weeks and 12 weeks after injections
The Western Ontario Rotator Cuff Index (WORC) is a self-administered assessment tool for rotator cuff disease. WORC has 21 questions in 5 domains consisting of work, physical symptoms, social well-being, emotional well-being, and sports and recreation. Each question is scored on a 100-mm, with higher scores demonstrating larger problems. Turkish validity of the WORC has been illustrated.
次要结局
- The Shoulder Pain and Disability Index (SPADI)(at baseline and change from baseline SPADI at 4 weeks and 12 weeks after injections)
- Visual Analogue Scale (VAS)(at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections)
研究者
Yasin Demir
Physical Medicine and Rehabilitation Associate Professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital