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

Carpal Tunnel Clinical Trial

— DUCATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219555
• Other study ID #: 14-003444
• Status: Completed
• Start date: September 2014
• Est. completion date: August 15, 2020

Study information

• Verified date: May 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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?

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome

Intervention

Drug:
• Steroid Injection
volume and specific steroid drug will be based on the recommendation of the treating clinician

Procedure:
• Carpel Tunnel surgery
Standard of care carpel tunnel surgery

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in CTSAQ symptom score	A change from baseline scores will be used to assess outcome	Baseline - 12 months
Secondary	Changes in Hand/wrist pain by VAS	A change from baseline will be used to assess outcome	Baseline - 12 month
Secondary	Change in CTSAQ function score	A change from baseline will be used to assess outcome	Baseline - 12 month
Secondary	Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring	CES-D questionnaire scoring will be used to assess outcomes	Baseline - 12 month

External Links

•   Mayo Clinic Clinical Trials