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Clinical Trial Summary

Sham-controlled, multi-center and remote patient-centered randomized controlled clinical trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in reducing symptoms of carpal tunnel syndrome (CTS). Mild to severe CTS-diagnosed patients will wear the device daily and evaluation will be based on the Boston Carpal Tunnel Questionnaire. Subjects are randomized into a treatment group or sham group for 8 weeks, then followed for 12 weeks post treatment.

Clinical Trial Description

It is hypothesized that daily wear of the study device results in significant improvements in patient-reported symptom severity. It is also hypothesized that the effects from active study device treatment are significantly greater than effects from sham treatment. In both cases, it is hypothesized that improvements are sustained or continue post-treatment.

This study is designed as a randomized, double-blind, sham-controlled, two-arm trial consisting of an eight week treatment phase (active study device or sham), followed by twelve weeks of follow-up. There are two study groups: the treatment group receiving the active study device and the sham group receiving a non-active sham device. Subjects will be informed that they have a 50:50 chance of receiving treatment or a sham. They will also be informed that if they receive sham treatment, they will be offered the active treatment at the conclusion of the sham post-treatment period. However, all subjects will not know what treatment they are on until the conclusion of the trial. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03498287
Study type Interventional
Source Pressure Profile Systems, Inc.
Contact Pauline Luong, ME
Phone 425-298-3775
Status Not yet recruiting
Phase N/A
Start date May 2018
Completion date June 2019

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