Efficacy of Ultrasound-guided Intra-Articular Hypertonic Dextrose(Prolotherapy) and Hydrodilatation for Frozen Shoulder
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the Shoulder Pain and Disability Index score
研究概览
简要总结
Objective: To determine whether ultrasound-guided Intra-Articular Hypertonic Dextrose and hydrodilatation improves pain and function in patients with frozen shoulder(FS)
详细描述
Setting: a medical center hospital. Participants: Subjects with primary FS with shoulder pain more than 3 months. Interventions: Participants randomly be assigned into A and B group: group A received ultrasound-guided hydrodilatation with hypertonic Dextrose with a mixture of 2mL of 50%, 1mL of 2% lidocaine, and 6ml normative saline ; group B : ultrasound-guided hydrodilatation with 9 mL of normative saline and 1 mL of 2% lidocaine.
Main Outcome Measures: The primary outcome measure was the Shoulder Pain and Disability Index score. Secondary outcomes were the VAS of shoulder pain level, muscle power and angles of shoulder passive range of motion, including flexion, abduction, extension, external rotation, and internal rotation at pretreatment and weeks 2, 4, 8, 12 and 24 of post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with primary FS who had experienced shoulder pain for more than 6 months and a reduction > 30° in passive ROM of the affected shoulder in at least two directions (forward flexion, abduction, or external rotation) compared with the contralateral side were evaluated for eligibility. 23 Subjects with any degree of tear or calcified tendinitis of rotator cuff tendons, previous shoulder surgery, previous intra-articular injection for the affected shoulder within 3 months of the study; or any secondary FS caused by metabolic, rheumatic, infectious arthritis, stroke, tumor, shoulder fracture/dislocation, or acute cervical radiculopathy were excluded. 23
排除标准
- 未提供
研究组 & 干预措施
evaluation prolotherapy for frozen shoulder
This pilot study highlighted that prospective studies are required to prove its clinical application for FS and other conditions.
干预措施: injection (Other)
结局指标
主要结局
the Shoulder Pain and Disability Index score
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Chih-Ya Chang
MD
Tri-Service General Hospital