Clinical trial NCT02219555: DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
Official title: DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel
Keywords: Carpal tunnel
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 204
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified among those presenting to the Hand Clinic with a referral diagnosis of CTS, and from those referred for EDS with a referral diagnosis of CTS, who are clinically indicated for either a steroid injection or surgery. Those who meet these and the inclusion criteria, do not meet the exclusion criteria, and who consent to participate will be entered in the study.

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 non-surgical or surgical treatment.


Eligibility 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?

Primary outcomes:
measure: Changes in CTSAQ symptom score
timeFrame: Baseline - 12 months
Secondary outcomes:
measure: Changes in Hand/wrist pain by VAS
timeFrame: Baseline - 12 month
measure: Change in CTSAQ function score
timeFrame: Baseline - 12 month
measure: Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring
timeFrame: Baseline - 12 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Peter Amadio, MD
role: PRINCIPAL_INVESTIGATOR
References: