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

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

Recruiting
21-80 years
All
Phase 1

Overview

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..

Description


Eligibility

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

Study details
    Carpal Tunnel Syndrome
    Carpal Tunnel Syndrome

NCT02219555

Mayo Clinic

19 February 2024

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