Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome

NCT ID: NCT07269613

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-07-31

Brief 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

Carpal Tunnel Syndrome (CTS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (PRF Group)

Group A (PRF Group): will Receive ultrasound-guided pulsed radiofrequency to the median nerve at the carpal tunnel.

Group Type: ACTIVE_COMPARATOR

Pulsed Radiofrequency

Intervention Type: PROCEDURE

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.

Group B (HD Group)

Group B (HD Group): will Receive ultrasound-guided hydrodissection of the median nerve using hyaluronidase solution.

Group Type: ACTIVE_COMPARATOR

Hyaluronidase Hydrodissection

Intervention Type: PROCEDURE

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.

Interventions

Pulsed Radiofrequency

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.

Intervention Type: PROCEDURE

Hyaluronidase Hydrodissection

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Amany Mahmoud Mohamed

Resident of Anesthesia, ICU and Pain management faculty of medicine, Sohag University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Sohag University

Sohag, Sohag Governorate, Egypt

Countries

Egypt

Central Contacts

Amany Mahmoud Mohamed, resident

Role: CONTACT

amany_mahmoud_post@med.sohag.edu.eg

01095062277

Facility Contacts

Amany Mahmoud Mohamed, resident

Role: primary

amany_mahmoud_post@med.sohag.edu.eg

01095062277

Other Identifiers

Soh-Med-25-9-20MS

Identifier Type: -

Identifier Source: org_study_id