Efficacy of different doses of Platelet-Rich Plasma for Moderate Carpal Tunnel Syndrome:Study Protocol for a Prospective, Randomized, Controlled trail

Background Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve disorder, with an incidence of approximately 0.4-1% in the general population. Recently, Platelet-rich plasma (PRP) injections attention as an innovative treatment, proving more effective than corticosteroids and dextrose. However, the optimal PRP therapeutic dosage remains unclear. Methods This double-blind, randomized controlled study will include 60 patients with moderate carpal tunnel syndrome. Participants will be randomly assigned to one of two groups: 3ml PRP or 5ml PRP, which will receive two injections 2 weeks apart. Injections are performed by experienced doctors under ultrasound guidance. Primary outcome measures include changes in the Visual Analogue Scale (VAS) of numbness from baseline to six months. Secondary outcomes involve ultrasound parameters (median nerve cross-sectional area, blood flow and swelling rate), Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score. Sensory nerve conduction velocity (SNCV), distal motor latency (DML) of the median nerve as measured by electromyography. The change of ultrasound images and nerve electrophysiology will be evaluated at baseline and 6-month follow-ups. Beyond that, other outcomes will be evaluated at baseline and 1-month, 3-month and 6-month follow-ups. The final statistical analysis of the data will be finished by using intention-to-treat and per-protocol analysis. Discussion This study aims to assess the efficacy of various doses of PRP injection in moderate CTS, and to offer guidance for the clinical application of injection therapy. Trial registration Chinese Clinical Trial Registry ChiCTR2400094746. Registered on 26 December 2024, https://www.chictr.org.cn/showproj.html?proj=252770