Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

Not Applicable

Suspended

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Incisionless Threaded Carpal Tunnel; Procedure: Standard Mini-Open Carpal Tunnel

• Registration Number: NCT04101955
• Lead Sponsor: Mayo Clinic

Brief Summary

The overarching long-term goal is to develop a CTS Treatment Center within the Hand Clinic that offers a variety of established and emerging treatment options in a multidisciplinary program. The ultra-minimally invasive carpal tunnel release would be one component of the program. Furthering the knowledge with regard to ultra-minimally invasive carpal tunnel release outcomes would facilitate the Hand Clinics ability to offer this procedure as a component of individualized care in the CTS Treatment Center to facilitate delivery of the appropriate level of care to the right patient.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Study Start: 2024-07
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• A diagnosis of CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
• Age 18-65 years old
• Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy.
• Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist
• Ability to complete all follow up appointments

Exclusion Criteria

• Previous CTS surgical release on affected side
• Diabetes mellitus
• Hypothyroidism
• Hand arthritis (rheumatologic or osteoarthritis)
• Pregnancy
• Electromyographic evidence of any condition other than CTS affecting the hand
• Workman's compensation
• Participants not willing to make follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incisionless Threaded Carpal Tunnel	Standard Mini-Open Carpal Tunnel	-
Standard Mini-Open Carpal Tunnel	Incisionless Threaded Carpal Tunnel	-
Incisionless Threaded Carpal Tunnel	Incisionless Threaded Carpal Tunnel	-
Standard Mini-Open Carpal Tunnel	Standard Mini-Open Carpal Tunnel	-

Primary Outcome Measures

Name	Time	Method
Visual analog pain scale	Time Frame: Change from Baseline to 12 months	Pain that participant is currently experiencing the in the hand or risk(0-100)
Strength testing of grip	Time Frame: Change from Baseline to 12 months	Use dynameters
Disability of the Arm Shoulder Hand DASH	Time Frame: Change from Baseline to 12 months	The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The main purpose of this study was to assess the longitudinal construct validity of the DASH among patients undergoing surgery. The second purpose was to quantify self-rated treatment effectiveness after surgery.
Strength testing of pinch	Time Frame: Change from Baseline to 12 months	Use pinch meters
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score	Time Frame: Change from Baseline to 12 months	Measured on a symptom severity scale from 1 to 5, where 1 is normal and 5 is very serious/continued/difficult

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States