Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome

N/ANot Yet RecruitingNCT07269613

Sohag University56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Carpal Tunnel Syndrome (CTS)

Interventions

Pulsed RadiofrequencyPROCEDURE

Pulsed 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.

Hyaluronidase HydrodissectionPROCEDURE

Hyaluronidase 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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 20-80 years 2. Clinical diagnosis of CTS with symptoms for at least 3 months 3. Electrophysiological evidence of mild to moderate CTS 4. No previous intervention for CTS in the affected hand Exclusion Criteria: 1. Previous wrist surgery or trauma 2. Medical history of polyneuropathy, thoracic outlet syndrome, or brachial plexopathy 3. Coagulopathy or local infection at injection site 4. Pregnancy or breastfeeding

Locations (1)

Faculty of Medicine Sohag University

Sohag, Sohag Governorate, Egypt

Outcomes

Primary Outcomes

Onset time of significant pain relief

The VAS will be used to quantify pain on the scale of 0 (no pain) to 10 (extremely severe pain). Onset time will be defined as the day when the VAS score declined by 40% or more

Time frame: 1 month

Secondary Outcomes

Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

BCTQ is the most used questionnaire in clinical studies for evaluation of the symptom severity and functional status of patients with CTS \[9\]. Symptom severity is rated based on 11 questions scored from 1 point (mildest) to 5 points (most severe), and the functional status is evaluated with 8 questions scored from 1 point (no difficulty with activity) to 5 points (cannot perform the activity at all)

Time frame: 1 week and 1, 3, 6 months

Cross-sectional area (CSA)

CSA of the median nerve will be measured at the proximal inlet of the carpal tunnel (at the level of the pisiform bone) by the same physician. The patients hold their wrists in a neutral position with the palm up and the fingers semi-extended. CSA will be measured three times, and the mean will be used for the analysis. Typically, a CSA greater than 9-10 mm2 at the wrist is considered suggestive of carpal tunnel syndrome. The ultrasonographic evaluation of median nerve CSA has high sensitivity (89%) and specificity (83%) for the diagnosis of CTS. This will be done at baseline and then at 1-, 3-, and 6-months post-injection. All measurements will be performed three times, and the mean of the three measurements was used for further statistical analyses

Time frame: baseline and then at 1-, 3-, and 6-months

Sensory nerve conduction velocity (SNCV)

The antidromic SNCV of the median nerve will be measured in all subjects. All examinations will be performed by the same physician in the same room maintained at a constant temperature of 25°C. Skin temperature on the hand and wrist will be maintained between 32.0 and 34.0°C. Active and reference ring electrodes will be placed over the 2nd proximal and distal interphalangeal joints. The median nerve will be stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at approximately 14 cm from the active electrode. will performed at baseline and 1, 3, and 6months post-injection.

Central Contacts

Amany Mahmoud Mohamed, resident

CONTACT

01095062277 amany_mahmoud_post@med.sohag.edu.eg

Data from ClinicalTrials.gov

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