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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02219555
Acronym
DUCATS
Enrollment
204
Registered
2014-08-19
Start date
2014-09-30
Completion date
2020-08-15
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel

Keywords

Carpal tunnel

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.

Interventions

volume and specific steroid drug will be based on the recommendation of the treating clinician

PROCEDURECarpel Tunnel surgery

Standard of care carpel tunnel surgery

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

Inclusion 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?

Design outcomes

Primary

MeasureTime frameDescription
Changes in CTSAQ symptom scoreBaseline - 12 monthsA change from baseline scores will be used to assess outcome

Secondary

MeasureTime frameDescription
Changes in Hand/wrist pain by VASBaseline - 12 monthA change from baseline will be used to assess outcome
Change in CTSAQ function scoreBaseline - 12 monthA change from baseline will be used to assess outcome
Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoringBaseline - 12 monthCES-D questionnaire scoring will be used to assess outcomes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026