Recruiting

Carpal Arch Space Augmentation

Sponsor:

University of Arizona

Code:

NCT06208709

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

carpal arch space augmentation (CASA)

standard of care (SOC)

Study Details

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT06208709

Start date

Apr 23, 2024

Status verified date

Feb, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CASA Arm

Arm that will be given the test intervention device.

active comparator: SOC Arm

Arm that is given a standard brace used for treating Carpal Tunnel Syndrome pain.

Interventions

carpal arch space augmentation (CASA)

A BOA brace with a balloon that is affixed internally. The device applies a small cyclic force of to the wrist. The cycles include a brief period of force applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep.

standard of care (SOC)

A BOA brace that can be adjusted to the arm of the participant.

Primary outcome measure

  • Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS) [ Time Frame: Baseline and up to 8 weeks ]

Central Contacts and Locations

Central contacts

Zong-Ming Li, PhD

520-626-6060lizongming@arizona.edu

Fernanda Camargo

520-621-2799fernandac44@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

More Information

Sponsor

University of Arizona

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • cts
  • carpal tunnel syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-02-23.