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Not yet recruiting NCT07269613

Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome

No phase Interventional Carpal Tunnel Syndrome (CTS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulsed Radiofrequency, Hyaluronidase Hydrodissection.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome (CTS). Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • Procedure 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 mu
  • 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 visualizat

Primary outcome measures

  • Onset time of significant pain relief [Time frame: 1 month]
Secondary outcome measures (3)
  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) [Time frame: 1 week and 1, 3, 6 months]
  • Cross-sectional area (CSA) [Time frame: baseline and then at 1-, 3-, and 6-months]
  • Sensory nerve conduction velocity (SNCV) [Time frame: baseline and 1, 3, and 6months post-injection]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine Sohag University — Sohag

Identifiers

NCT: NCT07269613 · Soh-Med-25-9-20MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗