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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome

Brief Summary: We hypothesize that the ultrasound detectable variations in nerve, tendon and SSCT mobility in patients with CTS may be useful clinically, not to diagnose CTS, but instead as functional biomarkers that correlate with, and thereby serve as predictors for, treatment response. To test this hypothesis, we propose a longitudinal clinical study in which patients presenting for treatment of CTS will be monitored by ultrasound and by clinical assessment before and after non-surgical and surgical treatment. We will correlate the clinical outcomes with the initial ultrasound motion patterns that we have found to be most variable in CTS patients. We will also test the hypothesis that successful treatment results in a change towards normal in the affected ultrasound variables.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: Changes in CTSAQ symptom score [ Time Frame: Baseline - 12 months ]

A change from baseline scores will be used to assess outcome


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Hand/wrist pain by VAS [ Time Frame: Baseline - 12 month ]
    A change from baseline will be used to assess outcome
  • Change in CTSAQ function score [ Time Frame: Baseline - 12 month ]
    A change from baseline will be used to assess outcome
  • 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


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: August 16, 2014
Date Started: September 2014
Date Completion: December 2019
Last Updated: March 25, 2017
Last Verified: March 2017