DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 2/13/2019 |
| Start Date: | September 2014 |
| End Date: | December 2021 |
| Contact: | Peter C. Amadio, M.D. |
| Phone: | 507-284-2511 |
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.
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.
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?
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Peter C. Amadio, M.D.
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