Open vs. Ultrasound-Guided Carpal Tunnel Release

NCT07814547 | Recruiting

• 2 other identifiers: CTS_USvsOS1070/2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

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).

  Baseline to 3 months postoperatively

Secondary Outcomes (4)

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

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

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

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

• Time to Full Return to Work - Number of Days After Surgery

  Up to 3 months postoperatively

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

  Within 12 months after surgery

Study Arms (2)

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

Open Surgical Carpal Tunnel Release (OSCTR) PROCEDURE

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.

Open Surgical Carpal Tunnel Release (OSCTR)

Ultrasound-Guided Carpal Tunnel Release (USGCTR) PROCEDURE

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.

Ultrasound-Guided Carpal Tunnel Release (USGCTR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AUVA General Trauma Hospital Salzburg: lead
• Salzburger Landeskliniken: collaborator
• Paracelsus Medical University: collaborator

Study Sites (2)

AUVA General Trauma Hospital Salzburg

Salzburg, 5010, Austria

RECRUITING

University Institute of Radiology, Paracelsus Medical Private University Salzburg

Salzburg, 5020, Austria

RECRUITING

Related Publications (5)

• 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.

  PMID: 24482073 BACKGROUND

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

  PMID: 19052017 BACKGROUND

• 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.

  PMID: 12371025 BACKGROUND

• 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.

  PMID: 40774338 BACKGROUND

• 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.

  PMID: 33629135 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Thomas Hausner, Prim. Priv. Doz. Dr.

  AUVA General Trauma Hospital Salzburg

  STUDY CHAIR

Central Study Contacts

Alexander M.T. Paszicsnyek, Dr.

CONTACT

+43 5939344211; alexander.paszicsnyek@auva.at

Nikolaos Schörghofer, Dr.

CONTACT

+435725554901; n.schoerghofer@salk.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

AU (2)