Carpal Tunnel Syndrome (CTS)NCT07230782
Ultrasound-Guided Percutaneous Release vs. Open Surgery for Carpal Tunnel Syndrome
A study testing Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament and Open release surgery in people with Carpal Tunnel Syndrome (CTS), run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament and Open release surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2021to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament, Open release surgery
- Keywords
- Carpal Tunnel Syndrome, Median Neuropathy, Ultrasonography, Surgical Procedures, Operative
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Ultrasound Guided Release of the Transverse Carpal LigamentProcedure or surgery
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.
Open release surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Ultrasound Guided Release | Experimental | Not described Receives: Procedure: Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament |
| Open surgery | Active comparator | Not described Receives: Procedure: Open release surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 12 months
Secondary outcomes (5)
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.
Measured: 3 and 12 months
Grip strength measured with a calibrated dynamometer
Grip strength expressed in kilograms (kg) using a standardized dynamometry protocol. Higher values indicate better hand strength.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start10 Jan 2021
- Primary completion20 Jan 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Matías Domínguez Prado, Fundacin Biomedica Galicia Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230782
- Sponsor's protocol ID
- 2020/580
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28028577de 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.
PubMed 22965620Castro-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.
PubMed 40340491
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Ultrasound-Guided Release of the Transverse Carpal Ligament Versus Open Surgery for Carpal Tunnel Syndrome: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07230782
- Acronym / sponsor ID
- 2020/580
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Carpal Tunnel Syndrome, Median Neuropathy, Ultrasonography, Surgical Procedures, Operative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Ultrasound Guided Release | Experimental | Procedure: Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament |
| Open surgery | Active comparator | Procedure: Open release surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Ultrasound Guided Release of the Transverse Carpal LigamentA 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. | Procedure or surgery | Percutaneous Ultrasound Guided Release |
| Open release surgeryA 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. | Procedure or surgery | Open surgery |
Primary outcome
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.
5 secondary outcomes
Pain intensity measured using the Visual Analog Scale
Time frame: 3 and 12 months
Grip strength measured with a calibrated dynamometer
Time frame: 3 and 12 months
Rate of procedure-related adverse events
Time frame: Intraoperative and up to 12 months postoperative
Time to return to normal daily activities
Time frame: Up to 12 months
Scar-related symptoms and satisfaction
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 28028577Petrover 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.
- Background: PubMed 22965620de 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.
- Results publication: PubMed 40340491Castro-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Ultrasound Guided Release of the Transverse Carpal Ligament and Open release surgery in people with Carpal Tunnel Syndrome (CTS), run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome measured by the Boston Carpal Tunnel Questionnaire (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07230782, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.