Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carpal Tunnel Syndrome
- Sponsor
- Pressure Profile Systems, Inc.
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change in SSS of the BCTQ at 28 Days vs Baseline
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).
Detailed Description
A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in SSS of the BCTQ at 28 Days vs Baseline
Time Frame: 28 days
The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms).
Secondary Outcomes
- Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline(2 months)