DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Changes in CTSAQ symptom score
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Steroid Injection (Drug)
Surgical treatment
When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician
Intervention: Carpel Tunnel surgery (Procedure)
Outcomes
Primary Outcomes
Changes in CTSAQ symptom score
Time Frame: Baseline - 12 months
A change from baseline scores will be used to assess outcome
Secondary Outcomes
- Changes in Hand/wrist pain by VAS(Baseline - 12 month)
- Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring(Baseline - 12 month)
- Change in CTSAQ function score(Baseline - 12 month)
Investigators
Peter C. Amadio, M.D.
PI
Mayo Clinic