NCT06208709 Carpal Arch Space Augmentation (CASA) Clinical Trial
| NCT ID | NCT06208709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arizona |
| Condition | Carpal Tunnel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2024-04-23 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2024-04-23 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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, 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06208709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carpal Tunnel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06208709 currently recruiting?
Yes, NCT06208709 is actively recruiting participants. Contact the research team at lizongming@arizona.edu for enrollment information.
Where is the NCT06208709 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT06208709 clinical trial?
NCT06208709 is sponsored by University of Arizona. The trial plans to enroll 116 participants.