Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

October 20, 2023 updated by: Alexander Y. Shin, M.D., Mayo Clinic

Ultrasound Guided - Incisionless Thread Carpal Tunnel Release Versus Standard Mini-Open Carpal Tunnel Release for the Treatment of Carpal Tunnel Syndrome: A Randomized Trial

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Incisionless Threaded Carpal Tunnel
Procedure: Incisionless Threaded Carpal Tunnel
ultra-minimally invasive thread carpal tunnel release
Procedure: Standard Mini-Open Carpal Tunnel
open surgical carpal tunnel release
Other: Standard Mini-Open Carpal Tunnel
Procedure: Incisionless Threaded Carpal Tunnel
ultra-minimally invasive thread carpal tunnel release
Procedure: Standard Mini-Open Carpal Tunnel
open surgical carpal tunnel release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score
Time Frame: 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
Time Frame: Change from Baseline to 12 months
Visual analog pain scale
Time Frame: Time Frame: Change from Baseline to 12 months
Pain that participant is currently experiencing the in the hand or risk(0-100)
Time Frame: Change from Baseline to 12 months
Strength testing of grip
Time Frame: Time Frame: Change from Baseline to 12 months
Use dynameters
Time Frame: Change from Baseline to 12 months
Disability of the Arm Shoulder Hand DASH
Time Frame: 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.
Time Frame: Change from Baseline to 12 months
Strength testing of pinch
Time Frame: Time Frame: Change from Baseline to 12 months
Use pinch meters
Time Frame: Change from Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Alexander Shin, MD, Mayo Clinic

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

Helpful Links

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-010569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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