Efficacy of Dextrose Prolotherapy Compare With Extracorporeal Shock Wave Therapy in the Treatment of Chronic Rotator Cuff Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
To compare the efficacy of dextrose solution injection with ESWT for pain reduction in rotator cuff tendinopathy.
Additionally, secondary objective is to evaluate DASH and active range of motion of shoulder joint
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic shoulder pain for at least 3 months
- •Unilateral affected side
- •History of unsuccessful conservative treatment
- •Age 18 years or older
排除标准
- •Rotator cuff complete tear
- •Local or generalized arthritis
- •Previous shoulder surgery
- •Previous history allergy to local anesthesia
- •Pregnancy
- •Current infectious or tumorous disease
- •Dysfunction in the neck or thoracic region of both
- •Coagulation disturbance
研究组 & 干预措施
Prolotherapy
Solution 3.6 mL of 25% dextrose and 0.4 mL xylocaine total 4.0 mL And Solution 3.5 mL of 15% dextrose and 0.8 mL xylocaine total 4.3 mL each site Injection interval week 0, 3 and 6 Ultrasound guided injection Injection into enthesis points
干预措施: Prolotherapy (Procedure)
Extracorporeal shock wave therapy (ESWT)
ESWT Treatment interval week 0, 1 and 2 Energy intensity 0.20-0.25 mJ/mm2 per impulse Frequency 4-5 Hz for 2,000 shocks
干预措施: Extracorporeal shock wave therapy (ESWT) (Device)
结局指标
主要结局
VAS score
时间窗: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Pain reduction VAS
次要结局
- Function DASH score(Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment)
- Shoulder ROM(Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment)
研究者
Songsuda Roongsaiwatana
Principal Investigator
Mahidol University