NCT06208709 · University of Arizona
Carpal Arch Space Augmentation (CASA) Clinical Trial
(CASA)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
Where
- Tucson, Arizona
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations