Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07269613

Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Sohag University

Sohag, Sohag Governorate, Egypt

Location contact

Amany Mahmoud Mohamed, resident

CONTACT

[email protected]

01095062277

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Onset time of significant pain relief

    Time frame: 1 month

    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

Secondary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

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

    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)

  2. Cross-sectional area (CSA)

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

    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

  3. Sensory nerve conduction velocity (SNCV)

    Time frame: baseline and 1, 3, and 6months post-injection

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany Mahmoud Mohamed, resident

CONTACT

[email protected]

01095062277

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.