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Behavioural Intervention
CASA Device for Carpal Tunnel Syndrome (CASA Trial)
N/A
Recruiting
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 and older
Diagnosed with right-handed or bilateral CTS. Participants will be treated only in the right hand.
Must not have
History of traumatic or chronic neuromusculoskeletal disorders involving the right upper extremity
Positive diagnosis of cervical disorders such as radiculopathy, spondylosis, tumor, and multiple sclerosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new device for treating carpal tunnel syndrome that applies a gentle force to the wrist while being worn during sleep. The effectiveness of the device will be measured by comparing patient-reported outcomes
Who is the study for?
This trial is for adults over 18 with right-handed or bilateral Carpal Tunnel Syndrome (CTS). It's focused on treating the right hand only, even if both hands are affected. Participants should have a confirmed diagnosis of CTS to join.
What is being tested?
The study is testing a new device called CASA against the standard care for CTS. The device applies cyclic force to the wrist during sleep and its effectiveness is measured by what patients report about their symptoms compared to those receiving usual treatment.
What are the potential side effects?
Potential side effects may include discomfort at the site where the device is worn, skin irritation from prolonged use, or increased symptoms if the applied force isn't well-tolerated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have carpal tunnel syndrome in my right hand or both hands.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long-term muscle or joint problem in my right arm.
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I have been diagnosed with a cervical disorder like radiculopathy or MS.
Select...
I have joint pain or arthritis in my right hand.
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I have had surgery for carpal tunnel syndrome on my right hand.
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I am currently pregnant.
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I will not join other clinical trials while in this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)
Secondary study objectives
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)
Michigan Hand Outcomes Questionnaire (MHQ)
Visual Analog Scales for pain, tingling, and numbness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CASA ArmExperimental Treatment1 Intervention
Arm that will be given the test intervention device.
Group II: SOC ArmActive Control1 Intervention
Arm that is given a standard brace used for treating Carpal Tunnel Syndrome pain.
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
539 Previous Clinical Trials
161,099 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,942 Total Patients Enrolled
4 Trials studying Carpal Tunnel Syndrome
324 Patients Enrolled for Carpal Tunnel Syndrome