Short- to Medium-term Outcome of Minimally Invasive Carpal Tunnel Release

NCT06997172 | Not Yet Recruiting DMC

• 1 other identifier: 2025-00406; mu25Kamphuis
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine whether minimally invasive, ultrasound-guided thread carpal tunnel release leads to faster functional recovery compared to standard open and endoscopic techniques in patients with carpal tunnel syndrome.

Conditions

Carpal Tunnel

Keywords

Percutaneous sonography guided release

Outcome Measures

Primary Outcomes (1)

• The objective functional assessment of the BCTQ score at 2 weeks

  Functional assessment of the BCTQ. The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Functional Status Scale evaluates the ability of the patient to use their hand in daily life using 8 questions, which are scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.

  2 weeks post-operative

Secondary Outcomes (15)

• The objective functional assessment of the BCTQ score

  4 and 6 weeks and 6 month post-operative

• Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status.

  2, 4 and 6 weeks and 6 months post-operative

• The subjective symptom severity score of the BCTQ

  2, 4 and 6 weeks and 6 months post-operative

• Hand-specific health

  2, 4 and 6 weeks and 6 months post-operative

• Functional recovery time

  up to 6 months post-operative

Study Arms (2)

TCTR (thread carpal tunnel release)

EXPERIMENTAL

Percutaneous sonography guided release of carpal tunnel

Procedure: TCTR (thread carpal tunnel release)

Standard of care technique

ACTIVE COMPARATOR

Standard of care technique (consisting of either the open or endoscopic technique) release of carpal tunnel

Procedure: Standard-of-care

Interventions

TCTR (thread carpal tunnel release) PROCEDURE

Percutaneous sonography guided release of carpal tunnel release

TCTR (thread carpal tunnel release)

Standard-of-care PROCEDURE

Open or endoscopic carpal tunnel release based on patients' and physicians' preferences

Standard of care technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or older
• Electroneurographically proven carpal tunnel syndrome
• Informed Consent for trial participation

You may not qualify if:

• Revision surgery
• Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Median Neuropathy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Saskia Kamphuis

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Central Study Contacts

Saskia Kamphuis, MD

CONTACT

+41 61 556 54 82; Saskia.Kamphuis@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CH (1)