跳至主要内容
临床试验/NCT04364425
NCT04364425Unknown不适用

Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
change in pain intensity

研究概览

简要总结

This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.

详细描述

Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, Shoulder Pain And Disability Index

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of adhesive capsulitis
  • a duration of complaints more than 3 months
  • a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.

排除标准

  • prior manipulation of the affected shoulder under anesthesia;
  • other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
  • neurologic deficits affecting shoulder function in normal daily activities;
  • shoulder pain caused by cervical radiculopathy
  • a history of drug allergy to hyaluronic acid;
  • pregnancy or lactation;
  • received injection into the affected shoulder during the preceding 3 months

研究组 & 干预措施

low dose steroid

Experimental

patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS

干预措施: Triamcinolone Acetonide (Drug)

low dose steroid

Experimental

patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS

干预措施: lidocaine hydrochloride (Drug)

low dose steroid

Experimental

patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS

干预措施: Normal saline (Drug)

high dose steroid

Active Comparator

patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS

干预措施: Triamcinolone Acetonide (Drug)

high dose steroid

Active Comparator

patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS

干预措施: lidocaine hydrochloride (Drug)

high dose steroid

Active Comparator

patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS

干预措施: Normal saline (Drug)

结局指标

主要结局

change in pain intensity

时间窗: 0, 6, 12 wks.

pain intensity was measured by visual analog scale (0-10)

次要结局

  • change in glenohumeral joint range of motion(0, 6, 12 wks.)
  • change in Shoulder Pain And disability index(0, 6, 12 wks.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验