Overview

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

Status:
Completed
Trial end date:
2020-08-15
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Lidocaine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Criteria
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?