Status:
COMPLETED
DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
Lead Sponsor:
Mayo Clinic
Conditions:
Carpal Tunnel
Eligibility:
All Genders
21-80 years
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...
Eligibility Criteria
Inclusion
- The following criteria must be answered yes to be enrolled:
- Does the patient have a clinical symptoms of Carpal Tunnel Syndrome (CTS)?
- Is the patient an adult between the ages of 21 and 80?
- 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?
- Does the patient have a clinical diagnosis of carpal tunnel syndrome?
- Has the patient had and electrodiagnostic study (EDS) or EMG? (Does not need to be positive\>)
- Is the patient able to understand and complete the study questionnaires and medical assessments in English?
- 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.
- Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery on the hand?
- Does the patient have a known tumor, mass or deformity of the study hand or wrist?
- Does the patient have a previous history of steroid injection into the carpal tunnel (injection group only)?
- Does the patient have any of the following diagnoses or conditions:
- cervical radiculopathy
- rheumatoid arthritis or other inflammatory arthritis, including gout
- osteoarthritis in the wrist
- renal failure
- morbid obesity (body mass index \>40)
- sarcoidosis
- peripheral nerve disease
- Diabetes
- thyroid disease or other metabolic disorder
- pregnancy
- amyloidosis
- major trauma (fractures or complete ligamentous tears) to the study hand or wrist?
- Is the patient a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia?
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2020
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02219555
Start Date
September 1 2014
End Date
August 15 2020
Last Update
May 17 2021
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905