Abstract
While spinal cord stimulation (SCS) is a well-established therapy to address refractory persistent spinal pain syndrome after spinal surgery (PSPS-T2), its lack of spatial selectivity and reported discomfort due to positional effects can be considered as significant limitations. As alternatives, new waveforms, such as burst stimulation and different spatial neural targets, such as dorsal root ganglion stimulation (DRGS), have shown promising results. Comparisons between DRGS and standard SCS, or their combination, have never been studied on the same patients. “BOOST DRG” is the first prospective, randomized, double-blinded, crossover study to compare SCS vs. DRGS vs. SCS+DRGS. Sixty-six PSPS-T2 patients will be recruited internationally in three centers. Before crossing over, patients will receive each stimulation modality for 1 month, using tonic conventional stimulation. After 3 months, stimulation will consist in switching to burst for 1 month, and patients will choose which modality/waveform they receive and will then be reassessed at 6 and 12 months. In addition to our primary outcome based on pain rating, this study is designed to assess quality of life, functional disability, psychological distress, pain surface coverage, global impression of change, medication quantification, adverse events, brain functional imaging and electroencephalography, with the objective being to provide a multidimensional insight based on composite pain assessment.
Highlights
Spinal cord stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain [1,2,3,4,5,6,7] by improving pain control and quality of life [8,9] in patients with failed back surgery syndrome (FBSS) or persistent spinal pain syndrome type 2 (PSPS-T2) [10]
We designed a randomized controlled trial (RCT) with a 3-month crossover design, where spinal cord stimulation (SCS), dorsal root ganglion (DRG) stimulation (DRGS) or SCS+DRGS (DUAL) will be proposed to a single patient presenting with refractory chronic lower limb neuropathic pain (e.g., complex regional pain syndrome (CRPS), diabetic foot peripheral neuropathy, foot and ankle peripheral neuropathy, radicular pain associated with PSPS-T2) and/or documented neuropathic refractory back pain
Secondary outcomes that will be compared between treatments and waveforms are changed between baseline and each follow-up visit in each of the following scores: pain intensity (VAS), pain surface, percentage of pain covered with paresthesia and lead selectivity; paresthesia discomfort measured by an 11-point numeric rating scale (NRS) while sitting, standing and lying down; health-related quality of life measured by the EuroQol 5 Dimensions 5 Level (EQ-5D-5L) questionnaire; functional disability measured by the Oswestry Disability Index (ODI); anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS) and the Pain Catastrophizing Scale (PCS); and patient satisfaction measured by the Patient Global Impression of Change Scale (PGIC)
Summary
Spinal cord stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain [1,2,3,4,5,6,7] by improving pain control and quality of life [8,9] in patients with failed back surgery syndrome (FBSS) or persistent spinal pain syndrome type 2 (PSPS-T2) [10]. Combining electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) to test these hypotheses, we gain insight on supraspinal mechanisms of action of SCS and DRGS, including tonic conventional stimulation (TCS), and burst stimulation modalities. To address these challenges, we designed a randomized controlled trial (RCT) with a 3-month crossover design, where SCS, DRGS or SCS+DRGS (DUAL) will be proposed to a single patient presenting with refractory chronic lower limb neuropathic pain (e.g., CRPS, diabetic foot peripheral neuropathy, foot and ankle peripheral neuropathy, radicular pain associated with PSPS-T2) and/or documented neuropathic refractory back pain. All patients will be switched to burst waveform with 1-month follow-up, and at 4-month follow-up, they will be asked to choose SCS, DRGS or SCS+DRGS with tonic conventional or burst waveform
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