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COMPLETED
NCT07904650
PHASE4

PRP Versus Saline Hydrodissection for CTS RCT

Sponsor: Medical University of Lodz

View on ClinicalTrials.gov

Summary

This single-center, single-blind, randomized controlled trial compared two injectates used for ultrasound-guided hydrodissection of the median nerve in adults with carpal tunnel syndrome: autologous platelet-rich plasma (PRP) and 0.9% normal saline (NS). Participants received a single hydrodissection with 5 mL of the allocated injectate per treated wrist; in participants with bilateral carpal tunnel syndrome, both wrists were treated with the same injectate. Symptom severity and functional status (Boston Carpal Tunnel Questionnaire), neuropathic pain (DN4 questionnaire), median nerve cross-sectional area on ultrasound, and grip strength parameters were assessed at baseline and at 3 and 6 months after the intervention. The study aimed to determine whether PRP provides benefit beyond the mechanical effect of hydrodissection with saline.

Official title: Platelet-Rich Plasma Versus Saline Hydrodissection for Carpal Tunnel Syndrome: A Randomized Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2025-03-23

Completion Date

2026-01-28

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous platelet-rich plasma

Approximately 5 mL of autologous platelet-rich plasma prepared from 15 mL of venous blood with the Arthrex ACP double-syringe system (centrifugation at 1500 rpm for 5 minutes), injected circumferentially around the median nerve under ultrasound guidance.

OTHER

Normal Saline (0.9% Sodium Chloride)

5 mL of 0.9% sodium chloride injected circumferentially around the median nerve under ultrasound guidance from a masked syringe.

PROCEDURE

Ultrasound-guided median nerve hydrodissection

Single ultrasound-guided hydrodissection of the median nerve at the carpal tunnel inlet (pisiform-scaphoid level) using a 22-gauge needle and an in-plane ulnar approach; the injectate is delivered circumferentially to separate the nerve from the flexor retinaculum, subsynovial connective tissue and flexor tendons. No local anesthetic is used.

Locations (1)

Medical University of Lodz

Lodz, Łódź Voivodeship, Poland