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临床试验/NCT05448794
NCT05448794Unknown不适用

Efficacy of Ultrasound-guided Intra-Articular Hypertonic Dextrose(Prolotherapy) and Hydrodilatation for Frozen Shoulder

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月20日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chih-Ya Chang

MD

Tri-Service General Hospital

研究点 (1)

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