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

November 13, 2025 updated by: Diego Matías Domínguez Prado, Fundacin Biomedica Galicia Sur

Percutaneous Ultrasound-Guided Release of the Transverse Carpal Ligament Versus Open Surgery for Carpal Tunnel Syndrome: A Prospective Comparative Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36208
        • Álvaro Cunqueiro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open surgery
Procedure: Open 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.
Experimental: Percutaneous Ultrasound Guided Release
Procedure: Percutaneous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome measured by the Boston Carpal Tunnel Questionnaire
Time Frame: 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.
3 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity measured using the Visual Analog Scale
Time Frame: 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.
3 and 12 months
Grip strength measured with a calibrated dynamometer
Time Frame: 3 and 12 months
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
Time Frame: 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.
Intraoperative and up to 12 months postoperative
Time to return to normal daily activities
Time Frame: Up to 12 months
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
Time Frame: 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.
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacin Biomedica Galicia Sur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Actual)

January 20, 2024

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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