Carpal Arch Space Augmentation (CASA) Clinical Trial for Carpal Tunnel Syndrome

This study is testing a new device called carpal arch space augmentation (CASA) for people with carpal tunnel syndrome. The CASA device is a brace with a balloon inside that gently applies and releases pressure to your wrist while you sleep. Researchers want to see if this device can reduce carpal tunnel symptoms, comparing it to a standard brace (standard of care, or SOC). You may be able to join if you are 18 or older and have been diagnosed with carpal tunnel syndrome in your right hand or both hands. The main way they will measure success is by asking you about your symptoms using a special questionnaire over an 8-week period. The current status of this study is unclear, but it plans to enroll 116 participants.

Study design
This is a randomized, single-blinded study comparing two treatments for carpal tunnel syndrome, planning to enroll 116 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be monitored from the start of the study up to 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06208709

Carpal Arch Space Augmentation (CASA) Clinical Trial

Recruiting
NAAges 18+InterventionalTreatment
University of Arizona
~116 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:carpal arch space augmentation (CASA)standard of care (SOC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)
Measured over Baseline and up to 8 weeks
Carpal Tunnel Syndrome

NCT06208709

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Arizona

    Tucson, Arizonano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

18 and older
Diagnosed with right-handed or bilateral CTS. Participants will be treated only in the right hand.

Exclusion

History of musculoskeletal or neurological conditions that may confound Carpal Tunnel Syndrome symptoms, including but not limited to:
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
  • Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)Baseline and up to 8 weeks

    The BCTQ SSS is a validated, self-reported instrument used in the assessment of pain intensity for patients with carpal tunnel syndrome. Higher numbers are worse outcomes. Possible scores range from 1 ("normal", "no pain", or "without difficulty") to 5 ("very serious", "continued", "more than 5 times") Change = (Baseline score - week 8 score)