Study of PM Modulation Therapy in Trial Phase
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|ClinicalTrials.gov Identifier: NCT03110601|
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Device: Control - Conventional SCS Device: Test - Stimgenics SCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trialing of PM Modulation Therapy in Patients With Chronic Intractable Low Back Pain With or Without Leg Pain|
|Actual Study Start Date :||May 5, 2017|
|Actual Primary Completion Date :||October 12, 2017|
|Actual Study Completion Date :||October 12, 2017|
Active Comparator: Control - Conventional SCS
Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
Device: Control - Conventional SCS
Conventional SCS Parameters
No Intervention: Washout Period
1 day where no stimulation is provided
Experimental: Test - Stimgenics SCS
Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.
Device: Test - Stimgenics SCS
Stimgenics SCS Parameters
- Change in Pain Relative to Baseline and After a Trial Period [ Time Frame: Baseline and 4 days plus or minus 1 days ]Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.
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): NCT03110601
|United States, Illinois|
|Bloomington, Illinois, United States, 61701|