Jennifer Breel1,2, Frank Wille3,4, Agnes G C L Wensing3, Jan Willem Kallewaard3,5, Harmen Pelleboer6, Xander Zuidema3,4, Katja Bürger7, Stijn de Graaf6, Markus W Hollmann3. 1. Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. j.s.breel@amsterdamumc.nl. 2. Departments of Anesthesiology, Diakonessenhuis, Zeist, The Netherlands. j.s.breel@amsterdamumc.nl. 3. Departments of Anesthesiology, Amsterdam University Medical Centers, Location AMC, H1-156, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. 4. Departments of Anesthesiology, Diakonessenhuis, Zeist, The Netherlands. 5. Departments of Anesthesiology, Rijnstate, Arnhem, The Netherlands. 6. Departments of Anesthesiology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands. 7. Departments of Anesthesiology, Alrijne Hospital, Leiderdorp, The Netherlands.
Abstract
INTRODUCTION: Multicenter, randomized, double-blinded crossover study. The Netherlands (ClinicalTrials.gov NCT02112474). We hypothesized that the pain suppressive effects of 1000 Hz and 30 Hz spinal cord stimulation (SCS) strategies are equally effective in patients with chronic, neuropathic, unilateral leg pain after back surgery. METHODS:Thirty-two patients (18-70 years, minimum leg pain 50 mm on 100 mm visual analog scale (VAS), minimal back pain) were randomized (1:1) to start 1000 Hz or 30 Hz neurostimulation for 9 days. After a 5-day washout, they crossed over, for another 9 days. Primary outcome was pain suppression (mean of VAS scores 4×/day) during the crossover period. The main investigators were blinded to strategy allocation, patients were blinded to the outcome, a blinded assessor analyzed the primary outcome. RESULTS: The primary outcome was analyzed in 26 patients. There was no period effect (delta 4 mm, p = 0.42, 95% CI [- 5, 13]), allowing direct intrapatient comparison of the treatment effect (delta 1 mm, p = 0.92, 95% CI [- 13, 14]). Ninety-two percent of patients in both periods experienced greater than 34% pain suppression (minimal clinically important difference, MCID). Secondary outcomes (22 patients): pain suppression and improved quality of life were sustained at 12 months; both were statistically significant and clinically relevant. Fifty percent of patients had greater than 80% pain suppression (p < 0.001). At study termination, all events were resolved; no unanticipated events were reported. Medtronic provided a grant for additional study costs. CONCLUSION: We conclude that our hypothesis regarding the effect of 1000 Hz and 30 Hz stimulation strategies on pain suppression was confirmed. Both stimulation strategies led to a large, sustainable, clinically relevant pain suppression and improvement in quality of life.
RCT Entities:
INTRODUCTION: Multicenter, randomized, double-blinded crossover study. The Netherlands (ClinicalTrials.gov NCT02112474). We hypothesized that the pain suppressive effects of 1000 Hz and 30 Hz spinal cord stimulation (SCS) strategies are equally effective in patients with chronic, neuropathic, unilateral leg pain after back surgery. METHODS: Thirty-two patients (18-70 years, minimum leg pain 50 mm on 100 mm visual analog scale (VAS), minimal back pain) were randomized (1:1) to start 1000 Hz or 30 Hz neurostimulation for 9 days. After a 5-day washout, they crossed over, for another 9 days. Primary outcome was pain suppression (mean of VAS scores 4×/day) during the crossover period. The main investigators were blinded to strategy allocation, patients were blinded to the outcome, a blinded assessor analyzed the primary outcome. RESULTS: The primary outcome was analyzed in 26 patients. There was no period effect (delta 4 mm, p = 0.42, 95% CI [- 5, 13]), allowing direct intrapatient comparison of the treatment effect (delta 1 mm, p = 0.92, 95% CI [- 13, 14]). Ninety-two percent of patients in both periods experienced greater than 34% pain suppression (minimal clinically important difference, MCID). Secondary outcomes (22 patients): pain suppression and improved quality of life were sustained at 12 months; both were statistically significant and clinically relevant. Fifty percent of patients had greater than 80% pain suppression (p < 0.001). At study termination, all events were resolved; no unanticipated events were reported. Medtronic provided a grant for additional study costs. CONCLUSION: We conclude that our hypothesis regarding the effect of 1000 Hz and 30 Hz stimulation strategies on pain suppression was confirmed. Both stimulation strategies led to a large, sustainable, clinically relevant pain suppression and improvement in quality of life.
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