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临床试验/NCT04916353
NCT04916353Unknown不适用

Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis

Taipei Medical University Shuang Ho Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月10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
发起方
入组人数
60
试验地点
2
主要终点
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)

研究概览

简要总结

The aim of this study is to investigate the echoguide hypertonic injection and compared steroid injection in subacromial bursitis patients about clinical and ultrasound image presentation.

详细描述

Subacromial bursitis is one of the major causes of chronic refractory shoulder pain. It can cause patients with shoulder pain when shoulder exercise and heavy lifting and limiting the range of motion. It can also influence the sleep quality due to pain symptoms of the shoulder. Usually, these patients had limited response to medication and physical modality. Steroid injection was often adopted for intervention, but the adverse effects should be considered. Therefore, prolotherapy was taken as an alternative treatment for chronic subacromial bursitis. It involves the injection of small volumes of an irritant agent, most commonly a hyperosmolar dextrose solution, at the lesion site. Hyperosmolar dextrose appears to be the most commonly used agent today. The aim of this study is to investigate hypertonic injections in subacromial bursitis patients about clinical and ultrasound image presentation. The investigators conducted a double-blinded randomized controlled trial for 60 participants with chronic shoulder pain for 3 months with subacromial bursitis. In the study group, the echo guide 20% dextrose water was injected into the lesion site, and the control group received the echo guide steroid injection. ROM, SPADI, VAS, x-ray, and ultrasound data were obtained at baseline. At weeks 2, 6, 12, ROM, SPADI, VAS, and ultrasound data were evaluated. The ANOVA and independent t-test are applied for analysis by SPSS 20.0 with a P value less than 0.05 as statistical significance.

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, Investigator)

入排标准

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

入选标准

  • Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by ultrasound and clinical shoulder pain lasting for more than 3 months.

排除标准

  • History of shoulder fracture and operation, with frozen shoulder or full thickness ruptur of rotator cuff, steroid, or hyaluronic acid, or platelet rich plasma (PRP) injection during the period of intervention and following up.

研究组 & 干预措施

20% hypertonic dextrose water injection group

Experimental

echo guide 20% dextrose water 3ml was injection in lesion site

干预措施: hypertonic dextrose water (Drug)

Steroid injection group

Active Comparator

Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group

干预措施: Triamcinolone Acetonide. (Drug)

结局指标

主要结局

Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)

时间窗: Week0 Week2 Week6 Week12

Shoulder Pain and Disability Index (SPADI), a self-administered assessment tool that was used to measure pain and disability related to shoulder disease. The SPADI consists of 5 pain and 8 disability items that are measured on a visual analog scale. Pain and disability subscales were calculated as the mean of the corresponding items on a 0-100 scale; the highest score indicated the most severe pain and disability. The total outcome score used for statistical analysis was calculated as the sum of the pain and disability subscales.

次要结局

  • Shoulder ROM (Range of Motion)(Week0 Week2 Week6 Week12)
  • Pain (VAS, Visual Analogue Scale)(Week0 Week2 Week6 Week12)
  • Ultrasound(Week0 Week2 Week6 Week12)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ShihWei Huang

Attending Physician

Taipei Medical University Shuang Ho Hospital

研究点 (2)

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