Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Shoulder pain and disability index
研究概览
简要总结
Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.
详细描述
A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up
排除标准
- •history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months
研究组 & 干预措施
Intervention group
Dextrose injection, one time
干预措施: Dextrose (Drug)
Control group
Normal saline injection, one time
干预措施: Normal saline (Drug)
结局指标
主要结局
Shoulder pain and disability index
时间窗: score change from baseline to 1 week, 1 month and 3 months after treatment
measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability
次要结局
- Disabilities of the arm, shoulder, and hand(score change from baseline to 1 week, 1 month and 3 months after treatment)
- range of motion(score change from baseline to 1 week, 1 month and 3 months after treatment)
- Visual analog scale(score change from baseline to 1 week, 1 month and 3 months after treatment)
研究者
Ru-Lan Hsieh
MD, Professor
Taipei Medical University