AzTrials
AzTrials

Carpal Tunnel Syndrome (CTS)NCT07814547

Open vs. Ultrasound-Guided Carpal Tunnel Release

An observational study of Carpal Tunnel Syndrome (CTS), run by AUVA General Trauma Hospital Salzburg at 2 sites in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Carpal Tunnel Syndrome (CTS) is the most prevalent entrapment neuropathy. Open Surgical Carpal Tunnel Release (OSCTR) remains the gold standard, while minimally invasive Ultrasound-Guided Carpal Tunnel Release (USGCTR) offers potential advantages including reduced postoperative morbidity and faster recovery. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Open Surgical Carpal Tunnel Release (OSCTR) and Ultrasound-Guided Carpal Tunnel Release (USGCTR)
Type of treatment
Surgery or procedure
How many people
200 participants
Where
2 sitesAustria
Study dates
1 Jun 2026to Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants will be recruited during routine clinical consultations at the outpatient clinics of the participating centers. Patients fulfilling the inclusion criteria will be informed about the study by their treating physicians. Participation is voluntary and does not affect the quality of medical care.

Who may be able to join

  • Electrophysiologically verified Carpal Tunnel Syndrome by EMG/nerve conduction studies, with the examination not older than 6 months at the time of inclusion.
  • Previous documented and exhausted conservative treatment
  • Existing indication for surgery that has been discussed with the patient and the patient's explicit wish to undergo surgical treatment.
  • Ability to provide informed consent and written informed consent
  • Age ≥18 years.

Who cannot join

  • Previous surgery at the affected location or revision procedures.
  • Pre-existing nerve lesions of the upper extremity, including traumatic transections or proximal injuries.
  • Manifest polyneuropathy.
  • Foreseeable loss to follow-up, for example inability to contact the participant or insufficient compliance, before the critical 3-month follow-up.
  • Age under 18 years.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander M.T. Paszicsnyek, Dr. contact

+43 5939344211

alexander.paszicsnyek@auva.at

Nikolaos Schörghofer, Dr. contact

+435725554901

n.schoerghofer@salk.at

Austria2 sites, 2 recruiting

  • AUVA General Trauma Hospital Salzburg

    Salzburg, 5010

    Alexander M.T. Paszicsnyek, Dr., +43 5939344211, alexander.paszicsnyek@auva.at

    Christoph Hirnsperger, Dr, +4359393 44253, christoph.hirnsperger@auva.at

    Recruiting

  • University Institute of Radiology, Paracelsus Medical Private University Salzburg

    Salzburg, 5020

    Christoph Knaptisch, Dr., +43 5725554915, c.knapitsch@salk.at

    Nikolaos Schörghofer, Dr., +435725554901, n.schoerghofer@salk.at

    Recruiting

Other trials in Austria

About this study

Official title: Prospective Multicenter Trial Comparing Open Surgical Decompression Versus Minimally Invasive Ultrasound-Guided Carpal Tunnel Release

Carpal Tunnel Syndrome (CTS) is the most prevalent entrapment neuropathy. Open Surgical Carpal Tunnel Release (OSCTR) remains the gold standard, while minimally invasive Ultrasound-Guided Carpal Tunnel Release (USGCTR) offers potential advantages including reduced postoperative morbidity and faster recovery. This prospective, multicenter observational cohort study compares the clinical outcomes, patient-reported outcomes, and socioeconomic impact of USGCTR versus OSCTR. A total of 200 patients, with 100 patients per cohort, will be included. Patient assignment is based on the participating center's standard of care. Follow-up assessments are performed preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months after surgery.

Read the detailed description

Carpal Tunnel Syndrome (CTS) is the most common compression neuropathy of the median nerve. Open Surgical Carpal Tunnel Release (OSCTR) has been established as the clinical gold standard. However, the procedure is associated with a palmar incision and may result in scar pain, including pillar pain, and delayed return to manual activities.

Ultrasound-Guided Carpal Tunnel Release (USGCTR) is a minimally invasive technique that permits division of the flexor retinaculum under continuous sonographic visualization through a minimal incision at the distal forearm or wrist crease. Potential advantages include avoidance of a painful scar in the load-bearing area of the hand and potentially faster recovery.

The study aims to compare functional recovery and symptom relief following OSCTR versus USGCTR. Secondary objectives include comparison of postoperative pain, subjective outcome, return to work, patient satisfaction, and complication rates.

This is a prospective, multicenter observational cohort study. Patients are not randomized. Assignment to the two cohorts is determined by the participating treatment center and its respective standard procedure. Patients choose the treatment center based on referral by their previously treating neurologist or on personal information. The study team does not influence this decision. Both procedures are established standard procedures routinely performed at the respective institutions.

Being tested
Open Surgical Carpal Tunnel Release (OSCTR), Ultrasound-Guided Carpal Tunnel Release (USGCTR)
Keywords
carpal tunnel syndrome, open surgical carpal tunnel release, ultrasound guided carpal tunnel release, osctr, usgctr, Boston carpal tunnel questionnaire, bctq, Return to Work
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open Surgical Carpal Tunnel Release (OSCTR)Procedure or surgery

    Open surgical decompression of the carpal tunnel (OSCTR) is performed at UKH Salzburg as the established standard surgical treatment for carpal tunnel syndrome. The procedure involves open surgical release of the flexor retinaculum. Intraoperative findings and immediate complications are documented.

  • Ultrasound-Guided Carpal Tunnel Release (USGCTR)Procedure or surgery

    Ultrasound-guided carpal tunnel release (USGCTR) is performed at the University Institute of Radiology of the Paracelsus Medical Private University. The minimally invasive procedure involves release of the flexor retinaculum under continuous sonographic visualization through a minimal incision at the distal forearm or wrist crease. Intraoperative findings and immediate complications are documented.

Study groups in NCT07814547
Study groupRoleWhat they receive
Open Surgical Carpal Tunnel Release (OSCTR)Patients undergoing open surgical decompression at AUVA Unfallkrankenhaus Salzburg as the standard procedure of the participating center.
Receives: Procedure: Open Surgical Carpal Tunnel Release (OSCTR)
Ultrasound-Guided Carpal Tunnel Release (USGCTR)Patients undergoing minimally invasive ultrasound-guided carpal tunnel release at the University Institute of Radiology, Paracelsus Medical Private University Salzburg, as the standard procedure of the participating center.
Receives: Procedure: Ultrasound-Guided Carpal Tunnel Release (USGCTR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score

    Mean difference in the change in the Boston Carpal Tunnel Questionnaire (BCTQ) score, combining the Symptom Severity Scale and Functional Status Scale, from the preoperative assessment (T0) to the 3-month postoperative assessment (T3).

    Measured: Baseline to 3 months postoperatively

Secondary outcomes (4)

  1. Pain Intensity - Visual Analog Scale (VAS), 0-10

    Change in pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10.

    Measured: Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively

  2. Subjective Hand Function - Single Assessment Numeric Evaluation (SANE), 0-100%

    Subjective hand function measured using the Single Assessment Numeric Evaluation (SANE), ranging from 0 to 100%.

    Measured: Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively

  3. Time to Full Return to Work - Number of Days After Surgery

    Number of days from surgery until full return to work.

    Measured: Up to 3 months postoperatively

  4. Postoperative Complications - Frequency of Wound Infection, Persistent Numbness, and Revision Surgery

    Frequency of wound infections, persistent numbness, or required revision procedures.

    Measured: Within 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study start1 Jun 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07814547
Sponsor's protocol ID
CTS_USvsOS
Other IDs
1070/2026
Status last verified
Sep 2026
First submitted
1 Sep 2026
Last updated
11 Sep 2026
Results posted
No
Individual data sharing
Undecided

Publications

  • Vasiliadis HS, Georgoulas P, Shrier I, Salanti G, Scholten RJ. Endoscopic release for carpal tunnel syndrome. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD008265. doi: 10.1002/14651858.CD008265.pub2.

    PubMed 24482073

  • Colbert SH, Mackinnon SE. Nerve compressions in the upper extremity. Mo Med. 2008 Nov-Dec;105(6):527-35.

    PubMed 19052017

  • Rotman MB, Donovan JP. Practical anatomy of the carpal tunnel. Hand Clin. 2002 May;18(2):219-30. doi: 10.1016/s0749-0712(01)00003-8.

    PubMed 12371025

  • Honold S, Loizides A, Skalla E, Gruber L, Plaikner M, Gruber H. Minimally invasive ultrasound-guided carpal tunnel release: long-term clinical outcomes. Ultraschall Med. 2025 Sep 8. doi: 10.1055/a-2678-8214. Online ahead of print.

    PubMed 40774338

  • Loizides A, Honold S, Skalla-Oberherber E, Gruber L, Loscher W, Moriggl B, Konschake M, Gruber H. Ultrasound-Guided Minimal Invasive Carpal Tunnel Release: An Optimized Algorithm. Cardiovasc Intervent Radiol. 2021 Jun;44(6):976-981. doi: 10.1007/s00270-021-02789-2. Epub 2021 Feb 24.

    PubMed 33629135

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS), run by AUVA General Trauma Hospital Salzburg at 2 sites in Austria.

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 5 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander M.T. Paszicsnyek, Dr. (+43 5939344211, alexander.paszicsnyek@auva.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score (time frame: Baseline to 3 months postoperatively). 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 NCT07814547, which also lists 5 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 11 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in