Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment116 (estimated)
SponsorUniversity of Arizona
Academic / other
Locations1 site (Tucson, Arizona)
StatusRecruiting
StartedApril 23, 2024
Main results expectedJuly 31, 2026
Study endsJuly 31, 2026
Registry record updatedFebruary 23, 2026
Trial IDNCT06208709 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

  • University of Arizona
    Tucson, Arizona, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Ultrasound-guided needle release plus dextrose (D5W) hydrodissection for carpal tunnel syndrome

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  • A mix of vitamins to help recovery after carpal tunnel surgery

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  • Symptom spread and pain sensitivity in carpal tunnel syndrome

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    Recruiting Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Istanbul, Usküdar · NCT07114913

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.