Device for treating carpal tunnel syndrome
Official title: Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial
Run by University of Arizona · NCT06208709 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Status | Recruiting |
| Started | April 23, 2024 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT06208709 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with right-handed or bilateral carpal tunnel syndrome.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the CASA approach is innovative, similar studies have shown promise in utilizing biomechanical interventions for carpal tunnel syndrome, suggesting potential for success.
Who can join: the full rules
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 it's running
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University of Arizona
Tucson, Arizona, United States Recruiting
Study contacts
- Study coordinator: Zong-Ming Li, PhD
- Email: lizongming@arizona.edu
- Phone: 520-626-6060
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Matrix Rhythm Therapy for Carpal Tunnel Syndrome
This study tests whether adding Matrix Rhythm Therapy to standard care helps people with mild-to-moderate carpal tunnel syndrome improve symptoms, hand function, grip and pinch strength, and quality of life.
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Carpal tunnel release vs placebo surgery in Finland
In this trial, people with carpal tunnel syndrome are randomly assigned to either standard carpal tunnel surgery or a pretend surgery to see if relief comes from the operation itself or from placebo effects.
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High-intensity laser therapy for carpal tunnel syndrome
This trial will test whether high-intensity laser therapy helps adults 18–65 with mild-to-moderate carpal tunnel syndrome reduce pain and improve nerve function and hand strength compared with a sham procedure.
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Ultrasound-guided needle release plus dextrose (D5W) hydrodissection for carpal tunnel syndrome
This trial tests whether combining ultrasound-guided partial release of the transverse carpal ligament with dextrose (D5W) hydrodissection provides better symptom relief for adults with carpal tunnel syndrome and at least moderate symptoms.
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A mix of vitamins to help recovery after carpal tunnel surgery
This will test whether taking alpha-lipoic acid, vitamin E, and B vitamins helps adults recover better after carpal tunnel release surgery.
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Symptom spread and pain sensitivity in carpal tunnel syndrome
This test looks at whether people with carpal tunnel syndrome whose symptoms spread beyond the usual finger area have higher central pain sensitivity, using a questionnaire and pressure pain testing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.