Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome

NCT07269613 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med-25-9-20MS
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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)

Keywords

pulsed radiofrequency versus hyaluronidase hydrodissection for treatment of carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (3)

• Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

  1 week and 1, 3, 6 months

• Cross-sectional area (CSA)

  baseline and then at 1-, 3-, and 6-months

• Sensory nerve conduction velocity (SNCV)

  baseline and 1, 3, and 6months post-injection

Study Arms (2)

Group A (PRF Group)

ACTIVE COMPARATOR

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

Procedure: Pulsed Radiofrequency

Group B (HD Group)

ACTIVE COMPARATOR

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

Procedure: Hyaluronidase Hydrodissection

Interventions

Hyaluronidase Hydrodissection 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.

Group B (HD Group)

Pulsed Radiofrequency 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 A (PRF Group)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20-80 years
• Clinical diagnosis of CTS with symptoms for at least 3 months
• Electrophysiological evidence of mild to moderate CTS
• No previous intervention for CTS in the affected hand

You may not qualify if:

• Previous wrist surgery or trauma
• Medical history of polyneuropathy, thoracic outlet syndrome, or brachial plexopathy
• Coagulopathy or local infection at injection site
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, Sohag Governorate, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Central Study Contacts

Amany Mahmoud Mohamed, resident

CONTACT

01095062277; amany_mahmoud_post@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, ICU and Pain management faculty of medicine, Sohag University

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

EG (1)