The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.
Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered. In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Thrive Clinic
Santa Rosa, California, United States
Nevada advanced pain specialists
Reno, Nevada, United States
OnSite Clinical Solutions
Asheville, North Carolina, United States
Ambulatory Surgery Center of Killeen
Killeen, Texas, United States
Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: baseline and 1 week after trial lead implant (trial stimulation)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: Baseline and 1 month follow up visit
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: Baseline and 3 month follow up visit
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time frame: Baseline and 6 month follow up visit
Change in Quality of Life Between Baseline and Trial Stimulation
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: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Quality of Life Between Baseline and Follow up 1
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)
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Premier Pain Solutions
Charleston, West Virginia, United States
Time frame: Baseline and 1 month follow up visit
Change in Quality of Life Between Baseline and Follow up 2
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: Baseline and 3 month follow up visit
Change in Quality of Life Between Baseline and Follow up 3
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: Baseline and 6 month follow up visit
Change in Disability Index Between Baseline and Trial Stimulation
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Disability Index Between Baseline and and Follow up 1
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: Baseline and 1 month follow up visit
Change in Disability Index Between Baseline and and Follow up 2
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: Baseline and 3 month follow up visit
Change in Disability Index Between Baseline and and Follow up 3
questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: Baseline and 6 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Pain Catastrophizing Scale Between Baseline and Follow up 1
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Time frame: Baseline and 1 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Follow up 2
Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Time frame: Baseline and 3 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Follow up 3
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Time frame: Baseline and 6 month follow up visit