Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial
University of Arizona
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.
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 transection of the transverse carpal ligament can disrupt essential anatomical, biomechanical, and physiological functions of the carpal tunnel. This clinical trial seeks to determine the effectiveness of the CASA device in alleviating CTS pain by augmenting the carpal arch space. During an early investigation of the transverse carpal ligament, investigators discovered the biomechanical mechanism of c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 musculoskeletal or neurological conditions that may confound Carpal Tunnel Syndrome symptoms, including but not limited to: 1. Diagnosed or suspected arthritis in the test wrist, hand, or finger joints 2. Prior neck trauma, whiplash injury, or any condition suggestive of cervical radiculopathy 3. Current or prior treatment from a healthcare provider such as neurologist, physical therapist, physiatrist, rheumatologist, n…
Interventions
- Devicecarpal arch space augmentation (CASA)
A BOA brace with a balloon that is affixed internally. The device applies a small cyclic force of to the wrist. The cycles include a brief period of force applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep.
- Devicestandard of care (SOC)
A BOA brace that can be adjusted to the arm of the participant.
Location
- University of ArizonaTucson, Arizona