Non-invasive CTS Device Clinical Trial
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|ClinicalTrials.gov Identifier: NCT03498287|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2018
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Device: Study Device Device: Sham Device||Not Applicable|
It is hypothesized that daily wear of the study device will result in significant improvements in patient-reported symptom severity. It is also hypothesized that the effects from active study device treatment will be significantly greater than effects from sham treatment. In both cases, it is hypothesized that improvements will be sustained post-treatment.
This study is designed as a randomized, double-blind, sham-controlled, two-arm trial consisting of an eight-week treatment period (active study device or sham), followed by one required follow-up four weeks later (at week 12).
There are two study groups: the active device 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 device, they will be offered the active device 4 weeks into the post-treatment period. However, all subjects will not know what treatment they are on until the conclusion of the trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Study Device
Small, non-invasive, stiff patch for the wrist
Device: Study Device
Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks).
Sham Comparator: Sham Device
Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.
Device: Sham Device
Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). *Note: participants in the sham group are given the real study device at the end of the Post-Treatment/Follow-up Phase.
- Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: 8 weeks post-Baseline ]11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
- Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: Post-treatment timepoint (12 weeks post-Baseline) ]11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
- eDiary Wear Time Response [ Time Frame: Daily for 8 weeks ]Time (duration) and percentage of days device worn as reported by participants in the eDiary
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): NCT03498287
|United States, California|
|Mission Pain & Spine|
|Mission Viejo, California, United States, 92691|
|South Bay Medical Center|
|Torrance, California, United States, 90710|
|United States, Ohio|
|Cleveland Clinic (Lerner Research Institute)|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Jae Son, PhD||Pressure Profile Systems|