Comparing the Efficacy of Cross-Linked and Non-Cross-Linked Hyaluronic Acid in Treating Subdeltoid Bursitis: A Double-Blind, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Shoulder pain and disability index
研究概览
简要总结
This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.
详细描述
A double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. The patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. Before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), 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) will be arranged.
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 80 Years（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 three months of intervention and follow-up
排除标准
- •history of malignancy
- •previous shoulder operation or injury
- •previous shoulder injections in the past three months
研究组 & 干预措施
cross-linked hyaluronic acid group
cross-linked hyaluronic acid injection, one-time, plus physical therapy
干预措施: cross-linked hyaluronic acid (Drug)
non-cross-linked hyaluronic acid group
non-cross-linked hyaluronic acid injection, one-time, plus physical therapy
干预措施: non-cross-linked hyaluronic acid (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
- 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)
- Disabilities of the arm, shoulder, and hand(score change from baseline to 1 week, 1 month and 3 months after treatment)
- Brief version of the World Health Organization Quality of Life 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