Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
Carpal Tunnel Syndrome, Median Neuropathy, Ultrasonography, Surgical Procedures, Operative
Brief 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.
Interventions
PROCEDUREPercutaneous Ultrasound Guided Release of the Transverse Carpal Ligament
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.
PROCEDUREOpen release surgery
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.
Sponsors
Fundacin Biomedica Galicia Sur
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome measured by the Boston Carpal Tunnel Questionnaire | 3 and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength measured with a calibrated dynamometer | 3 and 12 months | Grip strength expressed in kilograms (kg) using a standardized dynamometry protocol. Higher values indicate better hand strength. |
| Pain intensity measured using the Visual Analog Scale | 3 and 12 months | 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. |
| Rate of procedure-related adverse events | Intraoperative and up to 12 months postoperative | 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. |
| Time to return to normal daily activities | Up to 12 months | Self-reported number of days required to resume usual daily functions (work, household tasks, leisure). Lower values indicate faster recovery. |
| Scar-related symptoms and satisfaction | 3 and 12 months | 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. |
Countries
Spain
Outcome results
None listed