Actively Recruiting
Biomechanical Treatment of Carpal Tunnel Syndrome Using Carpal Arch Space Augmentation Device: A Pilot Clinical Trial
Led by University of Arizona · Updated on 2026-02-23
116
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Carpal tunnel syndrome (CTS) is a common hand disorder affecting millions of people. This clinical trial evaluates a novel device called the Carpal Arch Space Augmentation (CASA) device, designed to relieve CTS symptoms by gently applying cyclic pressure to the wrist during sleep. The study compares this device's effectiveness to that of a standard wrist brace, aiming to improve patient-reported outcomes related to pain and function. Participants are randomly assigned to one of two groups: the CASA device group or the standard of care (SOC) brace group. The CASA device uses an internal balloon to provide targeted wrist compression, delivering a pressure calibrated to 140 mmHg and a therapeutic force of 10 N during the night for four weeks. The SOC group wears a commonly used adjustable wrist brace without compression for the same period. The trial includes a run-in phase for compliance testing, an intervention phase with nightly use, and a four-week follow-up phase. Throughout the study, participants self-report their adherence and symptoms daily and during weekly phone calls with study staff. Researchers collect patient outcomes using validated questionnaires, including the Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS) and other pain and function measures, at baseline and up to eight weeks. The study also monitors the use of pain medications and any surgical interventions. Data analysis will explore treatment effects, adherence impact, and sex differences, with a total participation period of approximately 8 weeks.
CONDITIONS
Brief Title
Carpal Arch Space Augmentation (CASA) Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older
- Diagnosed with right-handed or bilateral carpal tunnel syndrome
- Treatment will be applied only to the right hand
You will not qualify if you...
- History of musculoskeletal or neurological conditions that could confuse carpal tunnel syndrome symptoms, such as arthritis in the test wrist, neck trauma, or cervical radiculopathy
- Prior treatment for neck, shoulder, or upper extremity musculoskeletal problems
- Traumatic or chronic neuromusculoskeletal disorders in the test upper extremity
- Diseases like uncontrolled diabetes, thyroid disease, rheumatoid arthritis, gout, lupus, renal failure, sarcoidosis, amyloidosis, or other systemic diseases affecting the median nerve
- Diagnosed cervical disorders on the same side as the test hand, including radiculopathy, spondylosis, tumor, or multiple sclerosis
- Symptomatic joint diseases or osteoporosis in the test hand
- Previous carpal tunnel release surgery in the test hand
- Corticosteroid injections for carpal tunnel syndrome in the test hand within 3 months prior to study start
- Current pregnancy
- Scheduled carpal tunnel release surgery in the test hand within the next 12 weeks
- Use of pain medication within 2 weeks before study start
- Participation in other carpal tunnel syndrome treatments or therapies during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo a baseline run-in period including compliance testing and a brief duration of device wearing to ensure adherence to protocol instructions before randomization.
1 to 2 visits depending on compliance testing
Duration - 4 weeks
Participants wear their assigned device (CASA or standard brace) nightly for four weeks, self-reporting adherence daily and receiving weekly phone calls to report outcome measures.
Weekly phone calls and daily self-reporting
Duration - 4 weeks
Participants continue weekly phone calls for four weeks after the treatment phase to monitor outcomes and adherence.
Weekly phone calls
Trial Site Locations
Total: 1 location
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
Z
Zong-Ming Li, PhD
F
Fernanda Camargo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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