ClinicalTrials.gg
RecruitingNCT07814547Updated Sep 11, 2026

Open vs. Ultrasound-Guided Carpal Tunnel Release

An observational study in Carpal Tunnel Syndrome (CTS), sponsored by AUVA General Trauma Hospital Salzburg. Recruiting at 2 sites in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by AUVA General Trauma Hospital Salzburg · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Carpal Tunnel Syndrome (CTS)

Keywords

  • carpal tunnel syndrome
  • open surgical carpal tunnel release
  • ultrasound guided carpal tunnel release
  • osctr
  • usgctr
  • Boston carpal tunnel questionnaire
  • bctq
  • Return to Work
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's planned enrollment of 200 is above the median of 92 across 131 observational studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

This is the only study on the registry with AUVA General Trauma Hospital Salzburg as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 and written informed consent
  • Age ≥18 years.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Open Surgical Carpal Tunnel Release (OSCTR)

    Patients undergoing open surgical decompression at AUVA Unfallkrankenhaus Salzburg as the standard procedure of the participating center.

    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.

    Procedure: Ultrasound-Guided Carpal Tunnel Release (USGCTR)

Interventions

  • ProcedureOpen Surgical Carpal Tunnel Release (OSCTR)

    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.

  • ProcedureUltrasound-Guided Carpal Tunnel Release (USGCTR)

    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.

06

What researchers measure

Primary outcomes

  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).

    Time frame: Baseline to 3 months postoperatively

Secondary outcomes

  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.

    Time frame: 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%.

    Time frame: 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.

    Time frame: 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.

    Time frame: Within 12 months after surgery

07

Study locations

2 of 2 sites recruiting
  • AUVA General Trauma Hospital Salzburg
    Salzburg, 5010, Austria
    Recruiting
    • Alexander M.T. Paszicsnyek, Dr. · Contactalexander.paszicsnyek@auva.at · +43 5939344211
    • Christoph Hirnsperger, Dr · Contactchristoph.hirnsperger@auva.at · +4359393 44253
    • Christoph Hirnsperger, Dr. · Sub investigator
    • Alexander Paszicsnyek, Dr. · Principal investigator
    • Thomas Hausner, Prim. Priv. Doz. Dr. · Sub investigator
  • University Institute of Radiology, Paracelsus Medical Private University Salzburg
    Salzburg, 5020, Austria
    Recruiting
    • Christoph Knaptisch, Dr. · Contactc.knapitsch@salk.at · +43 5725554915
    • Nikolaos Schörghofer, Dr. · Contactn.schoerghofer@salk.at · +435725554901
    • Klaus Hergan, Prof. Dr. · Sub investigator
    • Christoph Knapitsch, Dr. · Principal investigator
    • Nikolaos Schörghofer, Dr. · Sub investigator
08

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.

Of 38 non-industry observational studies under Carpal Tunnel Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 24 months is above that.

Counting every sponsor, half of 40 studies reached it within 13 months; a quarter within 8 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 11, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jul 2028
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07814547
Lead sponsor
AUVA General Trauma Hospital Salzburg
Collaborators
Salzburger Landeskliniken, Paracelsus Medical University
Responsible party
Sponsor
First posted
Sep 11, 2026
Start date
Jun 1, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Alexander M.T. Paszicsnyek, Dr.
Contact
alexander.paszicsnyek@auva.at
+43 5939344211
Nikolaos Schörghofer, Dr.
Contact
n.schoerghofer@salk.at
+435725554901
Thomas Hausner, Prim. Priv. Doz. Dr.
study chair · AUVA General Trauma Hospital Salzburg
View the source record on ClinicalTrials.gov ↗

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