Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study)
Abstract
:1. Introduction
Aims and Objectives
2. Materials and Methods
2.1. Design and Setting
2.2. Patient Selection
2.2.1. Inclusion Criteria
2.2.2. Non-Inclusion Criteria
2.2.3. Exclusion Criteria
2.3. Interventions
2.3.1. Phase 1: Lead Implantation
2.3.2. Phase 2: SCS+DRGS Trial Phase
2.3.3. Phase 3: IPG Implantation
2.4. Spinal Cord Stimulation Programming Modalities
- Pulse width: between 100 μs and 500 μs;
- Frequencies: between 30 Hz and 100 Hz;
- Amplitude: adapted to individual participant perception, the objective being to achieve a comfortable level of paresthesia. The minimum amplitude step size is 0.1 mA.
- 40 Hz BurstDRTM mode of constant-current stimuli with 5 spikes at 500 Hz per burst;
- Pulse width and interspike intervals of 1 ms;
- The minimum amplitude step size is 0.05 mA;
- Intermittent dosing: ratio from 1:3 (30-s ON and 90-s OFF) to 1:12 (30 s ON and 360 s OFF) [55].
2.5. Clinical Assessments
2.5.1. Primary Outcome
2.5.2. Secondary Outcomes
- Regaining functional capacity: having at least a 30% decrease in Oswestry Disability Index (ODI) percentage.
- Adequate global pain relief: having at least a 50% decrease in the Visual Analogic Scale (VAS).
- Improvement in quality of life: having at least a 0.2 increase in the EuroQol-5 Dimensions (EQ-5D) questionnaire.
- Decrease in psychological distress: having a decrease of at least 1.4 points in the Hospital Anxiety and Depression Scale (HADS) depression score.
- Decrease of at least 30% in pain surface (percentage of cm2): pain surface and its properties will be assessed using a pain mapping tool.
- Having a Patient Global Impression of Change (PGIC) score of at least 6/7.
- Drug intake: drug intake will be measured using the Medication Quantification Scale (MQS) and a reduction of at least 3.4 points will be considered as meaningful.
2.5.3. Process Measures
2.6. Procedures to Minimize Bias
2.7. Statistical Analysis
2.7.1. Sample Size and Power Calculations
2.7.2. Main Statistical Analysis
2.7.3. Extraction of Predictors of Long-Term Stimulation Efficacy
3. Discussion
3.1. Intra-Subject Comparability
3.2. “High-Fidelity” Composite Multidimensional Patient Assessment
3.3. A Focus on DRG. Indications and Technical Considerations
3.4. A Focus on Burst, as a Combined Waveform to DRGS, but Also to SCS+DRGS, as a New Hybrid Stimulation Modality
3.5. Study Limitations
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Inclusion Visit | Implantation Visit (Within 2 Months after Inclusion) | Visit M1 [1 Month ± 1 Week /M0] | Visit M2 [1 Month ± 1 Week /M1] | Visit M3 [1 Month ± 1 Week /M2] | Visit M4 [1 Month ± 1 Week /M3] | Visit M6 [2 Months ± 2 Weeks /M4] | VisitM12 [6 Months ± 3 Weeks /M6] | ||
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Lead Implantation Visit | Visit M0 (IPG Implantation + Randomization) | ||||||||
Patient information and consent form (R) | ✓ | ||||||||
Inclusion and non-inclusion criteria (R) | ✓ | ||||||||
Exclusion criteria (R) | | ||||||||
Socio-demographic data (C) | ✓ | ||||||||
Medical and surgical history (C) | ✓ | ||||||||
Spine MRI + thoraco-lumbar X-rays (front + profile) 1 (C) | ✓ | ||||||||
painDETECT Questionnaire (C) | ✓ | ||||||||
Brain imaging (fMRI/EEG) 2 (R) | ✓ 3 | ✓ | ✓ | ||||||
VAS (C) * | ✓ | ||||||||
ODI(C) *, HADS(C) *, PCS(R) *, EQ5D-5L(C) * | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Spine X-ray (C) | ✓(post-impl) | ||||||||
Mapping of the painful territory (C) * | ✓ | ✓ | ✓(post-impl) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Mapping of paresthesia coverage (C) * | ✓(post-impl) | ✓(post-impl) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Stimulation parameters and programming (C) | ✓(post-impl) | ✓(post-impl) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Patient satisfaction (PGIC) (C) * | ✓(post-impl) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Paresthesia discomfort 11-point NRS (C) * | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
5-day VAS diary (R) | | ||||||||
Concomitant medications 3 (C) | | ||||||||
AE/SAE/Device deficiencies | |
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Rigoard, P.; Roulaud, M.; Goudman, L.; Adjali, N.; Ounajim, A.; Voirin, J.; Perruchoud, C.; Bouche, B.; Page, P.; Guillevin, R.; et al. Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study). Medicina 2022, 58, 7. https://doi.org/10.3390/medicina58010007
Rigoard P, Roulaud M, Goudman L, Adjali N, Ounajim A, Voirin J, Perruchoud C, Bouche B, Page P, Guillevin R, et al. Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study). Medicina. 2022; 58(1):7. https://doi.org/10.3390/medicina58010007
Chicago/Turabian StyleRigoard, Philippe, Manuel Roulaud, Lisa Goudman, Nihel Adjali, Amine Ounajim, Jimmy Voirin, Christophe Perruchoud, Bénédicte Bouche, Philippe Page, Rémy Guillevin, and et al. 2022. "Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study)" Medicina 58, no. 1: 7. https://doi.org/10.3390/medicina58010007