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 intractable pain
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 no stimulation is being delivered. In this study the investigators propose to evaluate therapeutic efficacy of Intermittent DRG-S at 1 minute on: 1 minute off and 1 minute on: 2 minute off dosing in comparison to standard continuous DRG-S dosing and determine if there is noninferiority between the intermittent and continuous paradigms in chronic pain patients with permanent DRG-S implants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.
Spine and Pain Institute NY
New York, New York, United States
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Change in Disability Index Between Continuous and 1:1 Intermittent Dosing
Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
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Change in Disability Index Between Continuous and 1:2 Intermittent Dosing
Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing