Status:
ACTIVE_NOT_RECRUITING
Intermittent vs. Continuous Dorsal Root Ganglion Stimulation
Lead Sponsor:
Spine and Pain Institute of New York
Conditions:
Pain, Intractable
Pain, Chronic
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate and compare the therapeutic efficacy of intermittent Dorsal Root Ganglion Stimulation (DRG-S) to standard continuous stimulation in patients with chronic intra...
Detailed Description
Intermittent Dorsal Root Ganglion Stimulation (DRG-S) dosing consists of preprogrammed cycles during which stimulation is delivered with standard DRG-S parameters alternated with periods during which ...
Eligibility Criteria
Inclusion
- Subject is able to provide informed consent to participate in the study;
- Subject is 21 years of age or older;
- Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief \>50% for chronic intractable pain;
- Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study
Exclusion
- Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study
- Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04727216
Start Date
March 23 2021
End Date
September 15 2021
Last Update
September 22 2021
Active Locations (1)
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1
Spine and Pain Institute NY
New York, New York, United States, 10065