TerminatedNot Applicable

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

Stopped: Investigator's illness and recrutement difficulties

France7 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient, male or female, over 18 years of age * Patient with clinical carpal tunnel syndrome * Patient with unilateral or bilateral carpal tunnel syndrome. In the case of bilateral involvement, the more symptomatic hand (with the highest Boston score) will be included, with the patient agreeing that the second hand will not be operated on within one year. * Patient with carpal tunnel syndrome confirmed by an EMG less than 6 months old * Patient with carpal tunnel syndrome without motor or sensory deficits * Patient with carpal tunnel syndrome resistant to conservative treatment, including at least one corticosteroid injection * Patient agreeing to undergo surgery * Patient affiliated with or covered by a social security plan * Patient who has been informed and has signed a free and informed written consent. Exclusion Criteria: * Patient with another condition of the hand or wrist (Dupuytren's disease, inflammatory rheumatism, symptomatic osteoarthritis) * Patient with a history of previous hand or wrist surgery requiring treatment * Neurological sequelae of the hand * Patient with non-medicinal hypocoagulation or vitamin K antagonist overdose * Patient with a known allergy to lidocaine * Patient with an unhealed palmo-digital wound * Patient with a superficial or deep palmo-digital infection or inflammation * Patient who has received a cortisone injection in the hand or wrist within the last month. - Patient with type 1 diabetes or poorly controlled d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Severity of symptoms" subscore of the Boston Questionnaire

Timeframe: 3 months after surgery

Trial details

NCT IDNCT07668310

SponsorRamsay Générale de Santé

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-15

View on ClinicalTrials.gov More Carpal Tunnel Syndrome (CTS) trials