Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hand grip strength
研究概览
简要总结
The Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of carpal tunnel syndrome (CTS). Here we propose to assess the effectiveness of PRP as co-adjuvant in surgical treatment of CTS by open carpal tunnel release.
Design: Randomized Controlled Trial. Setting: Local Hospital.
详细描述
Carpal tunnel syndrome (CTS) is a common disorder with an estimated annual incidence of 125-542 in adults, and an estimated prevalence of 1 to 5 percent in the general population. CTS is the most frequent compressive focal mononeuropathy and causes pain, paresthesia and weakness of the median nerve distribution in patients.
The treatment of the CTS includes both, conservative and surgical treatment depending on the severity of the symptoms.
Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of CTS, however its potential used as co-adjuvant in surgical treatment has not been assessed.
We propose a randomized clinical trial in patients in which the surgical treatment is indicated. Participants in the intervention group receive a PRP injection, and in the control group a platelet-poor plasma injection after open carpal tunnel release. The evaluation is performed pretreatment as well as on the 6st week after treatment. Outcome measures include: hand grip strength (primary outcome), pain, sympton severity and functional status.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Carpal Tunnel Syndrome (CTS)
- •Conservative treatment failure
排除标准
- •Previous CTS surgery on the same side
- •Wrist fracture/trauma in history
- •Polyneuropathy
- •Diabetes mellitus
- •Cervical neuropathy
研究组 & 干预措施
Experimental
Platelet-rich plasma
干预措施: Platelet-poor plasma (Procedure)
Platelet-poor plasma
Platelet-poor plasma
干预措施: Platelet-poor plasma (Procedure)
Platelet-poor plasma
Platelet-poor plasma
干预措施: Platelet-rich plasma (Procedure)
Experimental
Platelet-rich plasma
干预措施: Platelet-rich plasma (Procedure)
结局指标
主要结局
Hand grip strength
时间窗: 6 weeks
Hand grip strength measured with dynamometer
次要结局
- Functional status(6 weeks)
- Pain(6 weeks)
- Sympton severity(6 weeks)
- Wound healing(6 weeks)
研究者
Juan F. Lisón Párraga, Dr
Head of Medicine
Cardenal Herrera University