Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- VAS (Visual Analogue Scale),
研究概览
简要总结
to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.
详细描述
Carpal tunnel syndrome (CTS) accounts for approximately 90% of peripheral entrapment neuropathy cases. Existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .Surgery indicated in Patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. Empirical evidence indicates that many patients with CTS have self-limiting symptoms and respond to splinting and anti-inflammatory medications. Recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •patients with signs and symptoms of CTS and a confirmed diagnosis of mild and moderate CTS based on clinical and electrophysiological studies were included.
排除标准
- •history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
- •history of local corticosteroid injection in the past 3 months.
- •atrophy of thenar muscles.
- •previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
- •Patients with autoimmune or hematologic disorders, NSAID consumption 2 days prior to injection, treatment with antiplatelet and anticoagulant agents, Hb level under 12 g/dl, and platelet count under 150,000 in ml.
研究组 & 干预措施
surgical group.
30 patients went to the surgical release of carpal tunnel.
干预措施: 30 patients went to surgical procedure (Procedure)
medical group.
30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.
干预措施: 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support. (Drug)
injection group.
Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments
干预措施: Injection (Other)
结局指标
主要结局
VAS (Visual Analogue Scale),
时间窗: at baseline and at 3 and 6 months post injection.
The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Electrophysiological study of median nerve.
时间窗: at baseline and at 3 and 6 months post injection.
motor and sensory conductive of the median nerve.
次要结局
未报告次要终点
研究者
Dalia Salah Saif
principle investigator
Menoufia University