Carpal Arch Space Augmentation (CASA) Clinical Trial
ConditionCarpal Tunnel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
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 criteria
Qualifiers
18 and older
Diagnosed with right-handed or bilateral CTS. Participants will be treated only in the right hand.
Disqualifiers
Diagnosed or suspected arthritis in the test wrist, hand, or finger joints
Prior neck trauma, whiplash injury, or any condition suggestive of cervical radiculopathy
Current or prior treatment from a healthcare provider such as neurologist, physical therapist, physiatrist, rheumatologist, neurosurgeon, orthopedic surgeon or chiropractor for cervical radiculopathy or other musculoskeletal problem involving the neck, shoulder, and or upper extremity
History of traumatic or chronic symptomatic neuromusculoskeletal disorders involving the upper extremity to be tested.
Trial design
Treatments tested in this trial
- carpal arch space augmentation (CASA)
- standard of care (SOC)
Treatment groups
116 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Arizona
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov