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Effectiveness of PErcutaneous Ultrasound-guided Carpal Tunnel Release: a Non-inferiority Study With Surgery as Comparator

NCT07668310 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-07-16

No results posted yet for this study

Summary

Carpal tunnel syndrome is a common condition caused by compression of the median nerve. Tingling in the first three or four fingers, usually at night or upon waking, is the most frequent symptom. Reduced sensation in the fingers and clumsiness can also occur, and in severe cases, there may even be weakness in thumb abduction with thenar muscle wasting. Carpal tunnel syndrome (CTS) is the most commonly diagnosed nerve compression syndrome. The annual incidence of diagnosis varies depending on the study and the country. It's estimated at 3.8 per thousand in the general population, 1 to 2 per thousand in men, 4 to 5 per thousand in women, with a peak between ages 40 and 60.

Medical treatment combines removing a microtraumatic factor, immobilization with a brace, and giving 1 to 2 cortisone injections into the carpal tunnel. The results are good in purely sensory cases. If it doesn't work, things get worse despite treatment, or in severe cases from the start (severe sensory problems, loss of strength, muscle wasting), surgery is recommended.

Several teams have recently demonstrated the benefits of using a minimally invasive ultrasound-guided surgical technique to perform flexor retinaculum sectioning under ultrasound guidance. This technique offers increased safety thanks to continuous ultrasound monitoring and the visualization of median nerve variants. Rojo et al. compared ultrasound surgery with a 1 mm incision to mini-open surgery with a 20 mm incision in 128 patients. This study suggests that a minimally invasive approach could allow for faster functional pain recovery compared to conventional surgery.

This project is based on the hypothesis that the proposed ultrasound-guided percutaneous release technique has an efficacy and tolerability profile suitable for widespread use in the indication of carpal tunnel syndrome resistant to conservative treatment, and that it can therefore reduce the need for conventional surgery in this indication.

Conditions

  • Carpal Tunnel Syndrome (CTS)

Interventions

PROCEDURE

Carpal tunnel surgery

The aim of this study is to compare the conventional surgery to the percutaneous ultrasound-guided carpal tunnel release procedure. One group is doing the conventional surgery and the other the procédure to evaluate.

OTHER

Questionnaires

EVA, Boston and Quick Dash questionnaires : all study visits

Sponsors & Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-03-15
Completion
2025-03-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668310 on ClinicalTrials.gov