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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Ultrasound Guided Release | Experimental |
| |
| Open surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament | Procedure | A Kemis H3® knife (Newclip, France) with a 12MHz probe were utilized. An 8-10 mm incision was made on the ulnar side of the palmaris longus tendon proximal to the wrist crease. The Kemis H3® knife (Newclip, France) was introduced, with ultrasound visualization ensuring identification and protection of the median nerve and ulnar artery. The flexor retinaculum was sectioned under longitudinal and transverse ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome measured by the Boston Carpal Tunnel Questionnaire | The Boston Carpal Tunnel Questionnaire - Symptom Severity Scale and Functional Status Scale, each scored from 1 (no symptoms / no difficulty) to 5 (severe symptoms / inability to perform activities), where higher scores indicate worse clinical symptoms and greater functional impairment. | 3 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity measured using the Visual Analog Scale | The Visual Analog Scale for pain (0-10 points), where 0 represents no pain and 10 represents the worst imaginable pain, and higher scores indicate worse pain intensity. | 3 and 12 months |
| Grip strength measured with a calibrated dynamometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvaro Cunqueiro Hospital | Vigo | Pontevedra | 36208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28028577 | Background | Petrover D, Silvera J, De Baere T, Vigan M, Hakime A. Percutaneous Ultrasound-Guided Carpal Tunnel Release: Study Upon Clinical Efficacy and Safety. Cardiovasc Intervent Radiol. 2017 Apr;40(4):568-575. doi: 10.1007/s00270-016-1545-5. Epub 2016 Dec 27. | |
| 22965620 | Background | de la Fuente J, Miguel-Perez MI, Balius R, Guerrero V, Michaud J, Bong D. Minimally invasive ultrasound-guided carpal tunnel release: a cadaver study. J Clin Ultrasound. 2013 Feb;41(2):101-7. doi: 10.1002/jcu.21982. Epub 2012 Sep 11. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2020 | Oct 3, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D020423 | Median Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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|
| Open release surgery | Procedure | A short palmar incision (<4 cm) was made along the radial axis of the fourth finger, extending to Kaplan's line. Dissection proceeded to the palmar fascia and flexor retinaculum, which was divided under direct vision and with median nerve protection. |
|
Grip strength expressed in kilograms (kg) using a standardized dynamometry protocol. Higher values indicate better hand strength. |
| 3 and 12 months |
| Rate of procedure-related adverse events | Incidence of complications directly attributable to the surgical procedure (e.g., neurovascular injury, pillar pain, infection, incomplete release). Reported as frequency and percentage. No scale applicable. | Intraoperative and up to 12 months postoperative |
| Time to return to normal daily activities | Self-reported number of days required to resume usual daily functions (work, household tasks, leisure). Lower values indicate faster recovery. | Up to 12 months |
| Scar-related symptoms and satisfaction | Assessed using a numeric rating scale from 0 (no symptoms / completely satisfied) to 10 (severe symptoms / completely dissatisfied). Higher scores indicate worse scar-related discomfort or lower satisfaction. | 3 and 12 months |
| 40340491 | Result | Castro-Menendez M, Balvis-Balvis P, Denisiuk M, Vazquez-Cancela O. Assessing the learning curve for percutaneous ultrasound-guided release in carpal tunnel syndrome. J Hand Surg Eur Vol. 2025 Nov;50(10):1365-1370. doi: 10.1177/17531934251338970. Epub 2025 May 8. |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |