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Not Yet RecruitingNCT07269613

Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome

Comparison of Ultrasound Guided Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome, a Prospective, Randomized, Controlled Clinical Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
56 (estimated)
Sponsor
Sohag University · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to compare the clinical efficacy and safety of ultrasound-guided pulsed radiofrequency and hyaluronidase hydrodissection in the treatment of carpal tunnel syndrome. This research seeks to evaluate both techniques in terms of pain relief, functional improvement, nerve conduction parameters, and potential complications, in order to identify the more effective minimally invasive approach for managing carpal tunnel syndrome.

Conditions

Interventions

TypeNameDescription
PROCEDUREPulsed RadiofrequencyPulsed Radiofrequency: Top neuropole needle 100-mm with a 10-mm active tip will be advanced with ultrasound guidance using the in-plane technique towards the median nerve. Sensory and motor stimulation will be tested when the needle is close to the median nerve. During sensory stimulation (50 Hz; 1-ms pulsed width; 0-3.0 volt), the patients will report paresthesia in the distal fingers. After performing a motor stimulation (2 Hz; 1-ms pulsed width; 0-3.0 volt), contractions of the thenar muscle will be observed. PRF lesion will then be carried out for 6 min, pulse width of 5 MS, 5 pulses per second and 35 volts at 42°C.
PROCEDUREHyaluronidase HydrodissectionHyaluronidase Hydrodissection: The patient will sit facing the examiner with the forearm supinated and semiflexed at 90°, and the wrist placed on the examination couch with semi extended fingers. The injection for a 5 mL volume of HD 1500 IU will be done under complete sterile conditions. A 26-gauge needle will be introduced from the lateral side toward the midline, using the in-plane approach to target the median nerve in the carpal tunnel using the ulnar approach. Ultrasonographic visualization of the needle tip will be continuous, the injection was done gradually, and the needle will be advanced dissecting the flexor retinaculum away from the median nerve via gradual drug infiltration.

Timeline

Start date
2025-12-01
Primary completion
2026-01-01
Completion
2026-07-01
First posted
2025-12-08
Last updated
2025-12-09

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07269613. Inclusion in this directory is not an endorsement.