Status:
RECRUITING
Carpal Arch Space Augmentation (CASA) Clinical Trial
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research proposes to evaluate the effectiveness of a novel device designed for the treatment of carpal tunnel syndrome. The device applies a small cyclic force to the wrist. The cycles include a ...
Detailed Description
Carpal tunnel syndrome is a commonly diagnosed disorder of the hand that affects 3.7% of the population. Carpal tunnel release surgery can provide some symptomatic relief to patients but surgical tran...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 18 and older
- Diagnosed with right-handed or bilateral CTS. Participants will be treated only in the right hand.
- Exclusion Criteria
- History of traumatic or chronic neuromusculoskeletal disorders involving the right upper extremity.
- Systemic diseases (e.g. diabetes, thyroid disease, rheumatoid arthritis, gout, renal failure, hemodialysis, sarcoidosis, amyloidosis)
- Positive diagnosis of cervical disorders such as radiculopathy, spondylosis, tumor, and multiple sclerosis
- Degenerative joint diseases in the right hand (e.g., Osteoarthritis)
- Osteoporosis in the right hand
- History of carpal tunnel release in the right hand
- History of conservative CTS treatments in the right hand within the 3 months preceding study initiation (e.g. splinting, corticosteroid injections, oral anti-inflammatory medication, physical therapy)
- Body mass index greater than 35
- Women who are currently pregnant
- Patients who have carpal tunnel release surgery scheduled for the next 12 weeks.
- Patients who have taken pain medication within 2 weeks prior to initiation of the study.
- Will not participate in other CTS treatment or therapies during this study
Exclusion
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06208709
Start Date
April 23 2024
End Date
February 1 2026
Last Update
November 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona
Tucson, Arizona, United States, 85724