A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome (TTP-50)

April 4, 2022 updated by: Alexander Y. Shin, M.D., Mayo Clinic

A Prospective Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome: A Transform the Practice Study

To compare the incisionless thread carpal tunnel release with the standard mini-open carpal tunnel release (standard of care) in patients with bilateral carpal tunnel syndrome. Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release. The investigators hypothesize that the incisionless thread carpal tunnel release (TCTR) will be no different than the standard mini-open release (MOR) with regard to symptom improvement and safety and will be less painful, result in quicker return to work and will be less costly.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A diagnosis of bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
  • Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release
  • Age 18-65 years of age
  • Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome.
  • 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
  • Able and willing to complete all follow-up appointments

Exclusion Criteria:

  • Previous CTS surgical release on any of their hands
  • Diabetes mellitus
  • Hypothyroidism
  • Significant Hand arthritis (rheumatologic or osteoarthritis)
  • Pregnancy
  • Electromyographic evidence of any condition other than CTS affecting the hand
  • Workman's compensation

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: Dominant hand-open Carpal Tunnel Release
Standard mini-open carpal tunnel release (standard of care) on the dominant hand.
Procedure: Carpal Tunnel Procedure (open)
Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release.
Other Names:
  • Carpal Tunnel Procedure (Incisionless)
Other: Dominant hand-Incisionless thread carpal tunnel release
Incisionless thread carpal tunnel release on the dominant hand.
Procedure: Carpal Tunnel Procedure (open)
Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release.
Other Names:
  • Carpal Tunnel Procedure (Incisionless)

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: 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
Change from Baseline to 12 months
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)
Change from Baseline to 12 months
Strength testing of grip and pinch
Time Frame: Change from Baseline to 12 months
Use dynameters and pinch meters
Change from Baseline to 12 months
Disability of the Arm Shoulder Hand DASH
Time Frame: Change from Baseline to 12 months
he 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.
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

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

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 (Actual)

February 5, 2019

Primary Completion (Actual)

July 27, 2020

Study Completion (Actual)

July 27, 2020

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-010050

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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