Carpal Arch Space Augmentation (CASA) Clinical Trial

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT06208709
Status
Recruiting
Apply to this trial

Conditions

  • Carpal Tunnel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carpal arch space augmentation (CASA) — DEVICE
    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) — DEVICE
    A BOA brace that can be adjusted to the arm of the participant.

Study Details

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.

Key Dates

Start date
Apr 23, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Zong-Ming Li, PhD

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZ

Related Studies