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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Carpal Tunnel

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-surgical treatment

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

Steroid Injection

Intervention Type DRUG

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

Surgical treatment

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

Carpel Tunnel surgery

Intervention Type PROCEDURE

Standard of care carpel tunnel surgery

Interventions

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Steroid Injection

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

Intervention Type DRUG

Carpel Tunnel surgery

Standard of care carpel tunnel surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

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?

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No