Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07814547

Open vs. 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AUVA General Trauma Hospital Salzburg, Salzburg, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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%.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander M.T. Paszicsnyek, Dr.

CONTACT

[email protected]

+43 5939344211

Nikolaos Schörghofer, Dr.

CONTACT

[email protected]

+435725554901

Sponsors and collaborators

Lead sponsor

AUVA General Trauma Hospital Salzburg

Other

Collaborators

  • Paracelsus Medical University
  • Salzburger Landeskliniken

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.