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

Study Overview
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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.

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

Conditions
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Carpal Tunnel

Intervention / Treatment
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* Drug: Steroid Injection
* Procedure: Carpel Tunnel surgery


Participation Criteria
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Eligibility Criteria
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The following criteria must be answered yes to be enrolled: Does the patient have a clinical symptoms of Carpal Tunnel Syndrome (CTS)? Is the patient an adult between the ages of 21 and 80? 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? Does the patient have a clinical diagnosis of carpal tunnel syndrome? Has the patient had and electrodiagnostic study (EDS) or EMG? (Does not need to be positive>) Is the patient able to understand and complete the study questionnaires and medical assessments in English? 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. Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery on the hand? Does the patient have a known tumor, mass or deformity of the study hand or wrist? Does the patient have a previous history of steroid injection into the carpal tunnel (injection group only)? Does the patient have any of the following diagnoses or conditions: cervical radiculopathy rheumatoid arthritis or other inflammatory arthritis, including gout osteoarthritis in the wrist renal failure morbid obesity (body mass index >40) sarcoidosis peripheral nerve disease Diabetes thyroid disease or other metabolic disorder pregnancy amyloidosis major trauma (fractures or complete ligamentous tears) to the study hand or wrist? Is the patient a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia?

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-surgical treatment<br>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 | Drug: Steroid Injection<br>* volume and specific steroid drug will be based on the recommendation of the treating clinician<br>|
| Surgical treatment<br>When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician | Procedure: Carpel Tunnel surgery<br>* Standard of care carpel tunnel surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CTSAQ symptom score | A change from baseline scores will be used to assess outcome | Baseline - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hand/wrist pain by VAS | A change from baseline will be used to assess outcome | Baseline - 12 month | 
| Change in CTSAQ function score | A change from baseline will be used to assess outcome | Baseline - 12 month | 
| Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring | CES-D questionnaire scoring will be used to assess outcomes | Baseline - 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpal tunnel