Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients: Analysis of Clinical and Sonographic Presentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
研究概览
简要总结
Using hypertonic dextrose water for chronic supraspinatus tendinosis and using ultrasound as assessment tool to evaluate the effect of intervention.
详细描述
Supraspinatus tendinosis is a degenerative process of tendon. It can be caused by external trauma episode and imbalanced of self-repair process. It can cause patients with shoulder pain when shoulder over head exercise and heavy lifting. It can also influence the sleep quality due to pain symptoms of shoulder. Usually these patients had limited response to medication and physical modality. Moreover, it can cause shoulder tear or rupture, which can disability with aging. Prolotherapy is an injection therapy for chronic painful musculoskeletal conditions. It involves the injection of small volumes of an irritant agent, most commonly a hyperosmolar dextrose solution, at multiple painful tendon and ligament insertions where they connect to bone, over several treatment sessions. The injection of an irritant solution initiates an inflammatory cascade at the site of injection, which causes fibroblast proliferation and subsequent collagen synthesis, resulting in a stronger tendon or ligament. Hyperosmolar dextrose appears to be the most commonly used agent today, with morrhuate sodium used slightly less often. There is promising recent evidence for prolotherapy, with hyperosmolar dextrose in treating painful tendinopathies. The aim of this study is to hypertonic injection in supraspinatus tendinosis patients about clinical and ultrasound image presentation. We conducted a double blinded randomized controlled trial for 60 participants with chronic shoulder pain for 3 months with supraspinatus tendonsis. In study group, one injection with 20% dextrose water was injection in supraspinatus tendon and control group received normal saline and Lidocaine. SPADI, VAS and ultrasound data were obtained before intervention and 2 weeks, 6 weeks and 12 weeks after injection after intervention. The ANOVA and independent t test are applied for analysis by SPSS 20.0 with 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
- 否
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 rupture 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
hypertonic dextrose water
20% hypertonic dextrose water injection for chronic shoulder spin
干预措施: hypertonic dextrose water (Device)
Normal Saline
normal saline and Lidocaine as placebo for sham group
干预措施: Normal saline and Lidocaine. (Device)
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
- Pain (VAS, Visual Analogue Scale)(Week0 Week2 Week6 Week12)
- Ultrasound(Week0 Week2 Week6 Week12)
- Shoulder ROM (Range of Motion)(Week0 Week2 Week6 Week12)
