Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: Carpal Tunnel Tissue Manipulation Device (CTMD)

• Registration Number: NCT02534493
• Lead Sponsor: Pressure Profile Systems, Inc.

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.

Study Timeline

• Study First Submitted: 2015-03-25
• Study Start: 2015-04
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-27
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2017-05-16
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Results First Posted: 2017-12-02
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carpal Tunnel Medical Device (CTMD)	Carpal Tunnel Tissue Manipulation Device (CTMD)	Carpal Tunnel Tissue Manipulation Device (CTMD)

Primary Outcome Measures

Name	Time	Method
Change in SSS of the BCTQ at 28 Days vs Baseline	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 Outcome Measures

Name	Time	Method
Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline	2 months	The secondary efficacy variable is the decrease in Symptoms Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ) obtained 2 months after the 28-day CTMD treatment period compared to the Baseline SSS score.

Trial Locations

Locations (1)

Mission Pain and Spine; 🇺🇸 Mission Viejo, California, United States