This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area.
Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation). Group 2 will have their frequency set at 5 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation) This study will be performed in a crossover fashion, meaning patients will be changed to the alternate dosing regimen at the 13-week time period.
Patients will be seen and evaluated prior to randomization and reprogramming, and thereafter evaluated at 4, 8, and 12-weeks. At the 12-week time period, patients will begin a 1-week washout period of continuous stimulation. At the 13-week time period, patients will be evaluated, crossed over to the other study arm and thereafter evaluated at 17, 21, and 25-weeks.
Age between 18 and 99
1-year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and/or leg pain
Endorse at least 50% pain relief in the targeted area over the last year
Must have been seen for routine follow-up within last 4 months
Significant lead migration, as determined by clinician
Other concurrent neuromodulation system in place
Corticosteroid injection in previous 30 days prior to enrollment
Intermittent dosing and/or failure within last 6m
Crossover
DRG stimulation 20 Hz 30/90
DeviceStimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF
DRG stimulation 5 Hz 30/90
DeviceStimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF
NRS pain scores
Subject's Numeric Rating Scale (NRS) score for pain being treated by DRG simulation for up to 3 months of designated treatment on a 22 point scale from 0-10 in 0.5 increments with 0 being no pain to 10 being the worse imaginable pain.
Patient Satisfaction with Treatment Score
At each study visit, subjects will rate their satisfaction with their current DRG stimulation therapy over the last 3 days on a scale from completely satisfied to completely dissatisfied as either: Completely satisfied (best outcome), Very satisfied, Slightly Satisfied, Neither satisfied nor dissatisfied, Slightly dissatisfied, Very dissatisfied, Completely dissatisfied (worse outcome)
CPAQ-8
At each study visit, subjects will complete the Chronic Pain Acceptance Questionnaire (CPAQ-8) which asks subjects to rate the truth of different statements about their chronic pain (i.e. I live a full life even though I have chronic pain) as either: Never true (0), Very rarely true (1), Seldom true (2), Sometimes true (3), Often true (4), Almost always true (5), Always true (6)
Current mode of stimulation
DRG settings as either Burst stimulation at 30 seconds ON/90 seconds OFF, or 30 seconds ON/360 seconds OFF
Stimulator settings- frequency
Subject's current DRG stimulator setting frequency in hertz (Hz)
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