Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 and older
• Diagnosed with right-handed or bilateral CTS. Participants will be treated only in the right hand.
Locations
United States
Arizona
University of Arizona
RECRUITING
Tucson
Contact Information
Primary
Zong-Ming Li, PhD
lizongming@arizona.edu
520-626-6060
Backup
Fernanda Camargo
fernandac44@arizona.edu
520-621-2799
Time Frame
Start Date: 2024-04-23
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 116
Treatments
Experimental: CASA Arm
Arm that will be given the test intervention device.
Active_comparator: SOC Arm
Arm that is given a standard brace used for treating Carpal Tunnel Syndrome pain.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Leads: University of Arizona