DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome (DUCATS)

May 13, 2021 updated by: Peter C. Amadio, M.D., Mayo Clinic
The purpose of this study is to learn if researchers can identify through ultrasound images and clinical assessment which subjects with carpel tunnel syndrome will do better following standard of care non-surgical or surgical treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

204

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

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be identified among those presenting to the Hand Clinic with a referral diagnosis of CTS, and from those referred for EDS with a referral diagnosis of CTS, who are clinically indicated for either a steroid injection or surgery. Those who meet these and the inclusion criteria, do not meet the exclusion criteria, and who consent to participate will be entered in the study.

Description

The following criteria must be answered yes to be enrolled:

  1. Does the patient have a clinical symptoms of Carpal Tunnel Syndrome (CTS)?
  2. Is the patient an adult between the ages of 21 and 80?
  3. Has the patient had symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long or radial border of ring finger?
  4. Does the patient have a clinical diagnosis of carpal tunnel syndrome?
  5. Has the patient had and electrodiagnostic study (EDS) or EMG? (Does not need to be positive>)
  6. Is the patient able to understand and complete the study questionnaires and medical assessments in English?
  7. Is the patient clinically indicated for treatment with either a steroid injection or surgery as treatment for their CTS?

EXCLUSION CRITERIA The following questions if answered yes will exclude the patient from participation in the study.

  1. Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery on the hand?
  2. Does the patient have a known tumor, mass or deformity of the study hand or wrist?
  3. Does the patient have a previous history of steroid injection into the carpal tunnel (injection group only)?
  4. Does the patient have any of the following diagnoses or conditions:

    1. cervical radiculopathy
    2. rheumatoid arthritis or other inflammatory arthritis, including gout
    3. osteoarthritis in the wrist
    4. renal failure
    5. morbid obesity (body mass index >40)
    6. sarcoidosis
    7. peripheral nerve disease
    8. Diabetes
    9. thyroid disease or other metabolic disorder
    10. pregnancy
    11. amyloidosis
    12. major trauma (fractures or complete ligamentous tears) to the study hand or wrist?
  5. Is the patient a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia?

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-surgical treatment
When clinically indicated, subjects will receive a standard of care carpal tunnel injection whose volume and specific steroid drug will be based on the recommendation of the treating clinician
volume and specific steroid drug will be based on the recommendation of the treating clinician
Surgical treatment
When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician
Standard of care carpel tunnel surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in CTSAQ symptom score
Time Frame: Baseline - 12 months
A change from baseline scores will be used to assess outcome
Baseline - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Hand/wrist pain by VAS
Time Frame: Baseline - 12 month
A change from baseline will be used to assess outcome
Baseline - 12 month
Change in CTSAQ function score
Time Frame: Baseline - 12 month
A change from baseline will be used to assess outcome
Baseline - 12 month
Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring
Time Frame: Baseline - 12 month
CES-D questionnaire scoring will be used to assess outcomes
Baseline - 12 month

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Peter Amadio, 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.

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)

September 1, 2014

Primary Completion (Actual)

August 15, 2020

Study Completion (Actual)

August 15, 2020

Study Registration Dates

First Submitted

August 16, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

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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