Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- visual analogue scale
研究概览
简要总结
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.
详细描述
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.
Each group will be injected twice with 2 weeks intervals. All procedures were done after informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve at the level of pisiform.
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
- Triple (Participant, Investigator, 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
- •mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography & electrophysiologically and classified according to the American Association of neuromuscular diagnostic medicine monograph).
排除标准
- •Patients with severe or secondary type of CTS
研究组 & 干预措施
PRP group
patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals
干预措施: platlet rich plasma (PRP) (Drug)
Steroid group
patients received ultrasound-guided injection of 2 mL steroids (40 mg triamcinolone acetonide). into the affected carpal tunnel. patients will be injected twice with 2 weeks intervals
干预措施: Triamcinolone Acetonide (Drug)
Control group
patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals
干预措施: Saline (Drug)
结局指标
主要结局
visual analogue scale
时间窗: Change from 3 months after last injection and 6 months after last injection
Scale for assessement the degree of pain along 0-10 scale
measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
时间窗: Change from 3 months after last injection and 6 months after last injection
electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
cross-sectional area (CSA) of the median nerve at the level of the pisiform.
时间窗: Change from 3 months after last injection and 6 months after last injection
ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.
次要结局
未报告次要终点
研究者
Mohammed Hassan Abu-Zaid
principal investigator
Tanta University