Actively Recruiting
Carpal Arch Space Augmentation (CASA) Clinical Trial
Led by University of Arizona · Updated on 2026-02-23
116
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 small time period of force is applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep. The efficacy of the treatment is evaluated based on patient reported outcomes. Treatment efficacy will also be evaluated based on comparisons to patient reported outcomes for a SOC treatment.
CONDITIONS
Official Title
Carpal Arch Space Augmentation (CASA) Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with carpal tunnel syndrome in the right hand or both hands (treatment only on right hand)
You will not qualify if you...
- History of musculoskeletal or neurological conditions that may affect symptoms, including arthritis in wrist/hand/finger joints
- Prior neck trauma, whiplash, or suspected cervical radiculopathy
- Current or past treatment for cervical radiculopathy or related musculoskeletal issues in neck, shoulder, or upper extremity
- History of traumatic or chronic neuromusculoskeletal disorders in the tested upper extremity
- Diagnosed diseases including uncontrolled diabetes, thyroid disease, rheumatoid arthritis, gout, lupus, renal failure, hemodialysis, sarcoidosis, amyloidosis, or other systemic diseases affecting the median nerve
- Diagnosis of cervical disorders affecting the same side as the test hand such as radiculopathy, spondylosis, tumor, or multiple sclerosis
- Symptomatic joint diseases in the test hand (e.g., osteoarthritis)
- Osteoporosis in the test hand
- History of carpal tunnel release surgery in the test hand
- Corticosteroid injection for carpal tunnel syndrome in the test hand within 3 months before study start
- Women who are currently pregnant
- Scheduled carpal tunnel release surgery for the test hand within 12 weeks
- Use of pain medication within 2 weeks before study start
- Participation in other carpal tunnel syndrome treatments or therapies during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
Z
Zong-Ming Li, PhD
CONTACT
F
Fernanda Camargo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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