Evaluation of Platelet-Rich Plasma Injection vs. Corticosteroid Injection in Idiopathic Carpel Tunnel Syndrome

Menoufia University1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2017年6月1日最近更新: 2024年1月18日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Menoufia University
入组人数: 40
试验地点: 1
主要终点: Median nerve sensory amplitude

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection Versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up period of 3 months.

The main question[s] it aims to answer are:

Does platelet-rich plasma injection provide better pain relief for CTS symptoms than steroid injection?
Does platelet-rich plasma improve parameters of median nerve conduction study than local steroid?

Participants will have:

A complete history and clinical examination, including sensory and motor examination and provocative tests for CTS.
Visual analog scale (VAS), Symptom severity scale (SSS), and functional severity scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) before local injection and three months after local injection by the same investigator.
Nerve conduction studies (NCS) for median and ulnar nerves were carried out before local injection and three months after local injection by the same investigator.

Researchers will compare the efficacy of a single PRP local injection compared to a single corticosteroid local injection for treating mild idiopathic CTS using nerve conduction studies (NCS), Visual Analog Scale (VAS), and Boston Carpal Tunnel Questionnaire (BCTQ) as objective and subjective outcome measures.

详细描述

Carpal tunnel syndrome (CTS) is the most known entrapment neuropathy. Diagnosis of CTS is clinical, which could be confirmed by nerve conduction study (NCS). Non-operative management is the first line of treatment, including splitting, antiinflammatory, and neurotonics.

There is evidence of improvement in CTS after local corticosteroid injection, but complications are still recorded [5]. Platelet-rich plasma (PRP) is a novel, promising treatment providing growth factors for nerve regeneration and inflammation relief. This field needs further evaluation and analysis compared to traditional local steroid injection.

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: Double (Participant, Care Provider)

入排标准

年龄范围: 30 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with mild primary CTS complaining of paresthesia in the palmar aspect of lateral three and half fingers of the hand. They are selected clinically and confirmed according to Padua's Neurophysiologic Severity Scale (PNSS) for CTS

排除标准

•Patients were excluded if they had moderate-to-severe NCS findings, space-occupying lesions within the carpal tunnel, traumatic CTS, pregnancy, diabetes mellitus, rheumatoid arthritis, or previous CTS surgery.

研究组 & 干预措施

Group I

Active Comparator

Local corticosteroid injection in group I: 1 ml of triamcinolone acetonide (40 milligram/1.0 mL) was locally injected in the wrist using a 25-gauge needle, which was slowly inserted 1 cm proximal to the distal wrist-flexion crease just on the radial side of the palmaris longus tendon. The injection was held if the patient experienced pain or a sensation of pins and needles in the median nerve distribution.

干预措施: Local corticosteroid injection (Drug)

Group II

Active Comparator

Local PRP injection in group II: 2 ml of PRP was injected using the same technique of corticosteroid local injection after 2-step centrifugation of the patient's blood using a specific device. Non-steroidal anti-inflammatory drugs were avoided for two weeks before and after the procedure to prevent the possibility of inhibition of platelet function.

干预措施: Platelet-rich Plasma Local injection (Drug)