Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- to assess pain alleviation through the visual analog scale (VAS)
研究概览
简要总结
Carpal tunnel syndrome is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent local ozone therapy could offer symptom improvement in scleroderma patients with Carpal tunnel syndrome
详细描述
Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.
Scleroderma patients are a special group which usually sufferers from such problem
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with scleroderma
- •complaining of carpal tunnel syndrome of 3-month duration or more
- •diagnosed axonal neuropathy using electrodiagnosis, nerve conduction study
排除标准
- •patient refusal
- •infection at the site of intervention
- •previous injection in the recent 3 months
- •Coagulopathy
研究组 & 干预措施
Ozone
After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance
干预措施: Ozone (Drug)
methylprednisolone acetate
After prepping and draping the area, intracarpal injection of methylprednisolone acetate 40mg, and 40 mg lidocaine (20 ml, volume) will be performed under sonographic guidance
干预措施: methylprednisolone acetate (Drug)
结局指标
主要结局
to assess pain alleviation through the visual analog scale (VAS)
时间窗: 6 months
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
次要结局
- Changes in median nerve conduction parameters(6 months)
研究者
Emad Zarief , MD
Associate professor of Anesthesia, ICU, and pain
Assiut University