Open vs. Ultrasound-Guided Carpal Tunnel Release
September 6, 2026 updated by: AUVA General Trauma Hospital Salzburg
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander M.T. Paszicsnyek, Dr.
- Phone Number: +43 5939344211
- Email: alexander.paszicsnyek@auva.at
Study Contact Backup
- Name: Nikolaos Schörghofer, Dr.
- Phone Number: +435725554901
- Email: n.schoerghofer@salk.at
Study Locations
-
-
-
Salzburg, Austria, 5010
- Recruiting
- AUVA General Trauma Hospital Salzburg
-
Contact:
- Alexander M.T. Paszicsnyek, Dr.
- Phone Number: +43 5939344211
- Email: alexander.paszicsnyek@auva.at
-
Contact:
- Christoph Hirnsperger, Dr
- Phone Number: +4359393 44253
- Email: christoph.hirnsperger@auva.at
-
Sub-Investigator:
- Christoph Hirnsperger, Dr.
-
Principal Investigator:
- Alexander Paszicsnyek, Dr.
-
Sub-Investigator:
- Thomas Hausner, Prim. Priv. Doz. Dr.
-
Salzburg, Austria, 5020
- Recruiting
- University Institute of Radiology, Paracelsus Medical Private University Salzburg
-
Contact:
- Nikolaos Schörghofer, Dr.
- Phone Number: +435725554901
- Email: n.schoerghofer@salk.at
-
Contact:
- Christoph Knaptisch, Dr.
- Phone Number: +43 5725554915
- Email: c.knapitsch@salk.at
-
Sub-Investigator:
- Klaus Hergan, Prof. Dr.
-
Principal Investigator:
- Christoph Knapitsch, Dr.
-
Sub-Investigator:
- Nikolaos Schörghofer, Dr.
-
-
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
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.
Description
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 informed consent and written informed consent
- Age ≥18 years.
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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Open Surgical Carpal Tunnel Release (OSCTR)
Patients undergoing open surgical decompression at AUVA Unfallkrankenhaus Salzburg as the standard procedure of the participating center.
|
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)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score
Time Frame: Baseline to 3 months postoperatively
|
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).
|
Baseline to 3 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity - Visual Analog Scale (VAS), 0-10
Time Frame: Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
|
Change in pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10.
|
Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
|
|
Subjective Hand Function - Single Assessment Numeric Evaluation (SANE), 0-100%
Time Frame: Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
|
Subjective hand function measured using the Single Assessment Numeric Evaluation (SANE), ranging from 0 to 100%.
|
Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
|
|
Time to Full Return to Work - Number of Days After Surgery
Time Frame: Up to 3 months postoperatively
|
Number of days from surgery until full return to work.
|
Up to 3 months postoperatively
|
|
Postoperative Complications - Frequency of Wound Infection, Persistent Numbness, and Revision Surgery
Time Frame: Within 12 months after surgery
|
Frequency of wound infections, persistent numbness, or required revision procedures.
|
Within 12 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Thomas Hausner, Prim. Priv. Doz. Dr., AUVA General Trauma Hospital Salzburg
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
- 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.
- Colbert SH, Mackinnon SE. Nerve compressions in the upper extremity. Mo Med. 2008 Nov-Dec;105(6):527-35.
- 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.
- 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.
- 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.
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)
June 1, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
September 1, 2026
First Submitted That Met QC Criteria
September 6, 2026
First Posted (Actual)
September 11, 2026
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 6, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTS_USvsOS
- 1070/2026 (Other Grant/Funding Number: Ethic committee Salzburg)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.