跳至主要内容
临床试验/NCT04931511
NCT04931511终止4 期

Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
20
试验地点
1
主要终点
The Change of Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

This study aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Besides, in order to propose clinical new technology which combines the advantages of the two therapies, improve the efficacy ratio of frozen shoulder therapy, and provide a frozen shoulder treatment plan according to health economics.

详细描述

In recent years, there have been studies suggesting that small doses of corticosteroid systemic medication and joint local injection to treat shoulder sleeve disease is equivalent, frozen shoulder is clinically in addition to shoulder sleeve disease another common cause of shoulder pain disease, local injection of small dose of corticosteroid is a clinically commonly used treatment of frozen shoulder mature therapy, however, because of the risk of joint infection and other serious complications, and it's personnel experience depended and high qualification requirements, resulting in higher treatment costs. However, it has not been widely used in clinical applications and is generally used as a second-line therapy for the treatment of frozen shoulders. There are studies suggesting that joint cavity hormone injection may be mainly effective through its systemic effect, however, there is currently no random blind control study comparing small doses of hormone systemic injection with local injection of shoulder joints to freeze shoulder, if the equivalence of the two can be confirmed through such studies will greatly change the clinical treatment of frozen shoulders, with hip injection and other systemic medication will provide great health economic advantages, and can avoid the inherent risk of joint cavity injection, reduce the social cost of frozen shoulder treatment.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary frozen shoulder
  • Older than 18 years of age and less than 75 years of age
  • The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
  • The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value
  • corticosteroid injections were not given within 3 months of visit

排除标准

  • A history of trauma, osteoarthritis, tumors, etc.
  • Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
  • There is a history of corticosteroid injections within 3 months of visit
  • Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
  • Both side shoulder joints become ill at the same time
  • The patient has not signed an informed consent form

研究组 & 干预措施

Gluteal muscle injection plus physical therapy group

Experimental

Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy

干预措施: Compound betamethasone Injection(Gluteal muscle injection) (Drug)

Gluteal muscle injection plus physical therapy group

Experimental

Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy

干预措施: Physical therapy (Behavioral)

Subacromial Ultrasound Guided injection plus physical therapy group

Experimental

Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy

干预措施: Compound betamethasone Injection(Subacromial Ultrasound Guided injection) (Drug)

Subacromial Ultrasound Guided injection plus physical therapy group

Experimental

Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy

干预措施: Physical therapy (Behavioral)

结局指标

主要结局

The Change of Shoulder Pain and Disability Index (SPADI)

时间窗: 0,1,2,4,8,12 weeks

The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.

次要结局

  • Anterior flexion of shoulder joint (0-180°)(0,1,2,4,8,12 weeks)
  • shoulder external rotator (0-180°)(0,1,2,4,8,12 weeks)
  • The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10)(0,1,2,4,8,12 weeks)
  • shoulder joint abduction (0-180°)(0,1,2,4,8,12 weeks)
  • shoulder internal rotator (1-18 score)(0,1,2,4,8,12 weeks)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

huang pintong

Director of the department of ultrasound

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究点 (1)

Loading locations...

相似试验