Ultrasound Guided Activated and Non-activated Platelet Rich Plasma Injection Versus Hydro Dissection for Treatment of Carpal Tunnel Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain visual analogue scale
研究概览
简要总结
PRP represents a promising, nonsurgical option for patients with carpal tunnel syndrome (CTS) with improvement in symptoms compared to placebo, conservative treatment, and local corticosteroid injections at 3-months postintervention. However, the lack of significant long-term results in pain and function demands the presence of future studies to further determine the long-term effect on a large group of homogeneous patients. More over to determine the clinical indications, effect on differing CTS severities, and the effects of preparation, concentration of the platelets and methods of activation of PRP
详细描述
- The patients are blinded to the type of drug and the researchers are blinded to the randomization. Randomization will be done using a research randomization program (http://www.randomizer.org)
- Patients will be randomly divided into three groups; each consists of 30 patients. Group 1 will include patients subjected to ultrasound guided activated PRP injection, group 2 will include patients subjected to ultrasound guided non-activated PRP injection, and group 3 patients will be subjected to ultrasound guided hydro dissection using a combination of steroid (Triamcinolone 40mg), LA (local anesthesia) and dextrose.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mild to moderate idiopathic Carpal Tunnel Syndrome with clinical manifestations, diagnosed by electrophysiological study and ultrasound. CTS grading will be performed on basis of an electrophysiological study following Stevens classification (Stevens; 1997).
- •Early CTS: abnormal findings only in both comparative studies (≥0.5ms difference in peak latency)
- •Mild CTS: abnormal median sensory study (peak latency ≥3.5ms)
- •Moderate CTS: abnormal median sensory study and prolonged median distal motor latency (onset latency ≥4.5ms)
- •Sever CTS: any of the above mentioned abnormalities together with the evidence of axonal loss either by absent median sensory response, low amplitude, or absent median motor response (<2µV)
排除标准
- •• Patients suffering from diabetes, hypothyroidism, rheumatoid arthritis, , cervical radiculopathy, polyneuropathy, brachial plexopathy, traumatic nerve injury, thoracic outlet syndrome, coagulopathy
- •Pregnancy
- •Previous corticosteroid injection into the carpal tunnel.
- •Previous carpal tunnel decompressive surgery.
研究组 & 干预措施
Activated PRP
PRP is activated by adding 200μl of 0.025 calcium chloride and used in hydrodissection.
干预措施: platelet rich plasma (Drug)
Non-Activated PRP
PRP is used directly in hydrodissection.
干预措施: platelet rich plasma (Drug)
Steroid group
Hydro dissection using a combination of steroid (Triamcinolone 40mg), local anesthetics and dextrose.
干预措施: platelet rich plasma (Drug)
结局指标
主要结局
Pain visual analogue scale
时间窗: 2 weeks,1,3 and 6 months
Ruler with number on it and the scale by measuring the distance in millimeter from 0 to 10 where is 0 means no pain and 10 means sever disabling pain and in between the different degrees of pain
次要结局
- Boston Carpal Tunnel Syndrome Questionnaire(2 weeks, 1,3 and 6 months)