Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
研究概览
简要总结
The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .
详细描述
Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder, which may cause serious restriction of daily activities and reduce quality of life. There are many ways in treating rotator cuff disorder with bursitis, including medication, physical therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal disorders. However, only few trials exist in studying hyperosmolar dextrose injection for rotator cuff disorder with bursitis and most of them have small sample size and not randomized. The aim of this study was to figure out the effects of sonographically guided subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis by a randomized controlled trial.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-65 years-old
- •pain lasting >3 months
- •Painful arc between 40° to 120° in abduction
- •positive Neer and Hawkins-Kennedy tests
- •positive Empty can test
- •pain in daily living activities
- •Bursa thickness more than 2mm in ultrasound
- •Rotator cuff tendinopathy
排除标准
- •history of significant shoulder trauma
- •history of surgery, fracture, or dislocation
- •adhesive capsulitis
- •full thickness rotator cuff tear
- •a long head of bicep tendon tear
- •Contra-indications to local dextrose injection (known blood coagulation disorders, warfarin therapy, allergy to dextrose)
- •previous shoulder steroid injection in one month
- •had any rheumatologic, systemic, or neurologic disorders
- •patients taking regular systemic NSAIDs or steroids
- •pregnant or breastfeeding mothers
结局指标
主要结局
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
时间窗: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
maximal visual analog scale (VAS) in the past week during shoulder activity. Visual analog scale is range from 0-10. The higher score indicated more severe pain.
次要结局
- Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy(before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy)
- Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy(before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy)
- Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy(before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy)
- Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy(before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy)