Study of a Wrist Device to Relieve Carpal Tunnel Syndrome by Increasing Carpal Arch Space

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 devices 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.

Carpal Arch Space Augmentation (CASA) Clinical Trial