Carpal Arch Space Augmentation (CASA) Clinical Trial
Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial
University of Arizona
116 participants
Apr 23, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- and older
- Diagnosed with right-handed or bilateral CTS. Participants will be treated only in the right hand.
Exclusion Criteria15
- History of musculoskeletal or neurological conditions that may confound Carpal Tunnel Syndrome symptoms, including but not limited to:
- 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.
- The following diseases: uncontrolled diabetes, thyroid disease, rheumatoid arthritis, gout, lupus, renal failure, hemodialysis, sarcoidosis, amyloidosis, additional systemic diseases that may have an effect on the peripheral median nerve.
- Positive diagnosis of cervical disorders affecting the same side of the body as the test hand such as radiculopathy, spondylosis, tumor, and multiple sclerosis
- Symptomatic joint diseases in the test hand (e.g., Osteoarthritis)
- Osteoporosis in the test hand
- History of carpal tunnel release in the test hand
- History of corticosteroid injection treatments for CTS in the test hand within the 3 months preceding study initiation
- Women who are currently pregnant
- Patients who have carpal tunnel release surgery scheduled for the next 12 weeks in their test hand.
- Patients who have taken pain medication, including over-the-counter products, within 2 weeks prior to initiation of the study.
- Will not participate in other CTS treatment or therapies during this study
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Interventions
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.
A BOA brace that can be adjusted to the arm of the participant.
Locations(1)
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NCT06208709