Device for treating carpal tunnel syndrome
Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial
This study tests a new device that gently pushes on the wrist while you sleep to see if it helps people with carpal tunnel syndrome feel better compared to using a regular wrist brace.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT06208709 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a novel device designed to treat carpal tunnel syndrome by applying a small cyclic force to the wrist during sleep. The device aims to augment the carpal arch space to alleviate pain and improve patient outcomes. Participants will be randomly assigned to receive either the CASA device or a standard of care wrist brace, with efficacy assessed through patient-reported outcomes. The study is designed to compare the performance of the CASA device against a widely accepted treatment method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with right-handed or bilateral carpal tunnel syndrome.
Not a fit: Patients with a history of traumatic or chronic neuromusculoskeletal disorders in the right upper extremity or those scheduled for carpal tunnel release surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a non-invasive treatment option for patients suffering from carpal tunnel syndrome.
How similar studies have performed: While the CASA approach is innovative, similar studies have shown promise in utilizing biomechanical interventions for carpal tunnel syndrome, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tucson, Arizona
- University of Arizona — Tucson, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Zong-Ming Li, PhD
- Email: lizongming@arizona.edu
- Phone: 520-626-6060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.