Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome
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|ClinicalTrials.gov Identifier: NCT02534493|
Recruitment Status : Completed
First Posted : August 27, 2015
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Device: Carpal Tunnel Tissue Manipulation Device (CTMD)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|Official Title:||Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Carpal Tunnel Medical Device (CTMD)
Carpal Tunnel Tissue Manipulation Device (CTMD)
Device: Carpal Tunnel Tissue Manipulation Device (CTMD)
This piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece for a duration of 2-14 hours.
Other Name: Wrist-Aid
- 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).
- Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534493
|United States, California|
|Mission Pain and Spine|
|Mission Viejo, California, United States, 92691|
|Principal Investigator:||Frank J. King, M.D.||Mission Pain and Spine|