CompletedNot Applicable

Ultrasound-Guided Percutaneous Release vs. Open Surgery for Carpal Tunnel Syndrome

Spain200 participantsStarted 2021-01-10

Plain-language summary

The goal of this clinical trial is to compare the clinical and functional outcomes of two surgical approaches for the treatment of carpal tunnel syndrome (CTS): ultrasound-guided percutaneous release of the flexor retinaculum and conventional open surgery. The study population includes adults diagnosed with carpal tunnel syndrome who are candidates for surgical treatment. The main questions this study aims to answer are: Does ultrasound-guided percutaneous flexor retinaculum release provide superior short-term functional outcomes compared with conventional open surgery? Does the minimally invasive approach lead to faster symptom relief and postoperative recovery? Researchers will compare the percutaneous ultrasound-guided technique with the traditional open palmar incision to determine whether the minimally invasive method offers measurable clinical advantages. Participants will: Undergo either ultrasound-guided percutaneous release or standard open surgical release, depending on group allocation. Complete validated clinical and functional assessments at predefined postoperative time points. Report symptom severity, functional status, and any procedure-related adverse events.

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: * Adults aged 18 years or older * Residence within the hospital's health area * Clinical and neurophysiological diagnosis of carpal tunnel syndrome * Underwent surgical treatment between January 2021 and January 2024 * Provided written informed consent for participation and for the publication of anonymized data Exclusion Criteria: * Previous surgery for the same pathology in the same hand * Presence of another associated hand pathology in the same hand * Patients unable or incapacitated to follow the study protocol

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

Functional outcome measured by the Boston Carpal Tunnel Questionnaire

Timeframe: 3 and 12 months

Trial details

NCT IDNCT07230782

SponsorFundacin Biomedica Galicia Sur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-20

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