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

Mayo Clinic

Status: Completed

Conditions: Carpal Tunnel

Treatments: Drug: Steroid Injection; Procedure: Carpel Tunnel surgery

Study type: Observational

Funder types: Other

Identifiers

NCT02219555

14-003444

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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?

Trial design

204 participants in 2 patient groups

Non-surgical treatment

Description:

When clinically indicated, subjects will receive a standard of care carpal tunnel injection whose volume and specific steroid drug will be based on the recommendation of the treating clinician

Treatment:

Drug: Steroid Injection

Surgical treatment

Description:

When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician

Treatment:

Procedure: Carpel Tunnel surgery