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.
| Original language | English |
|---|---|
| Pages (from-to) | 1189-1202 |
| Number of pages | 14 |
| Journal | Pain and Therapy |
| Volume | 10 |
| Issue number | 2 |
| Early online date | 2021 |
| DOIs | |
| Publication status | Published - Dec 2021 |
Keywords
- Chronic pain
- Neurostimulation
- Pain suppression
- Patient preference
- Patient-reported outcomes
- Quality of life
- Satisfaction
- Sleep
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In: Pain and Therapy, Vol. 10, No. 2, 12.2021, p. 1189-1202.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - A Comparison of 1000 Hz to 30 Hz Spinal Cord Stimulation Strategies in Patients with Unilateral Neuropathic Leg Pain Due to Failed Back Surgery Syndrome: A Multicenter, Randomized, Double-Blinded, Crossover Clinical Study (HALO)
AU - Breel, Jennifer
AU - Wille, Frank
AU - Wensing, Agnes G. C. L.
AU - Kallewaard, Jan Willem
AU - Pelleboer, Harmen
AU - Zuidema, Xander
AU - Bürger, Katja
AU - de Graaf, Stijn
AU - Hollmann, Markus W.
N1 - Funding Information: The study and journal’s Rapid Service Fee was funded by AMC Medical Research. The Amsterdam UMC, location AMC received a research grant from Medtronic. All participating sites received part of the equipment needed for the study free of charge (One RestoreSENSOR to be used as external stimulator, 1 × 8 Octad electrode sets and connection cables). Devices were reimbursed as in normal care. The financial support did not waive the rights of the participating sites to publish the results without undue delay. Medtronic did not have any role in the study design, data collection, analysis, or writing of the report. The Academic Medical Center received a small grant from Medtronic for data management costs and some equipment. Funding Information: Patient follow-up and data collection: M. de Klerk-de Ruiter, M.R. Kruis, K.P. Hendrickx, M.M. de Roos, C. Terwiel, C. Edelbroek, P.S. van Daalen, M. Hemels-Kouwen, A.J.M. Kroon, H. Festen-van der Weijde, A. Dekkers, C. de Gooier- van Ekris, L. Ekelschot, J. Leroux, A.A.J. van der Voort, Data entry: B. Geraedts. Independent physician: O. Teernstra. Clinical Epidemiologist: S. van Dieren. The study and journal?s Rapid Service Fee was funded by AMC Medical Research. The Amsterdam UMC, location AMC received a research grant from Medtronic. All participating sites received part of the equipment needed for the study free of charge (One RestoreSENSOR to be used as external stimulator, 1???8 Octad electrode sets and connection cables). Devices were reimbursed as in normal care. The financial support did not waive the rights of the participating sites to publish the results without undue delay. Medtronic did not have any role in the study design, data collection, analysis, or writing of the report. The Academic Medical Center received a small grant from Medtronic for data management costs and some equipment. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Jennifer Breel and Frank Wille designed the protocol, collected data, managed the study, conducted statistical analysis and drafted the manuscript. They both contributed equally and are co-first authors. Carin Wensing helped design the protocol, manage the study, performed randomization, and drafted the manuscript. Jan Willen Kallewaard, Katja Burger, Stijn de Graaf, Harmen Pelleboer and Xander Zuidema approved the protocol, implanted patients and approved the manuscript. Jennifer Breel had a consultancy for speaking fees with Medtronic, Abbott and Saluda Medical. Frank Wille reports grants and non-financial support from Medtronic. Jan Willem Kallewaard is a member of the Advisory Boards of Medtronic, Saluda, Abbott, Nevro and Boston Scientific. Markus Hollmann, Carin Wensing, Xander Zuidema, Stijn de Graaf, Harmen Pelleboer, Katja Burger have nothing to disclose. The study was approved by the Medische Ethische Toetsings Commissie (METC) of the Amsterdam UMC, location AMC, on 23 December 2013 (METC 2013_271) and registered with ClinicalTrials.gov (NCT02112474) [9] on 25 March 2014, before the first patient was enrolled (13 November 2014). It was conducted in compliance with all applicable regulatory and institutional guidelines (Declaration of Helsinki 1964 and its later amendments). The Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines and extension for crossover trials [10] and International Committee of Medical Journal Editors (ICMJE) recommendations [11] for reporting were used in the writing of this report. All patients signed an ethical committee approved informed consent before taking part in the study and for the use of their data in publications. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. Data will be made available on request after an embargo period and with restricted access. Mrs J. Breel had consultancies with Medtronic and Abbott at the time of the study. Dr F. Wille had consultancies with Medtronic and Abbott at the time of the study. Ms. A. Wensing was an employee of Abbott at the time of the study. Dr J.W. Kallewaard was and is on the Advisory Boards of Medtronic, Saluda, Abbott, Nevro and Boston Scientific during the study and currently. Dr K. Burger, Dr X. Zuidema, Dr H. Pelleboer, Dr S. de Graaf and Professor M.W. Hollmann have no disclosures. Publisher Copyright: © 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Chronic pain
KW - Neurostimulation
KW - Pain suppression
KW - Patient preference
KW - Patient-reported outcomes
KW - Quality of life
KW - Satisfaction
KW - Sleep
UR - http://www.scopus.com/inward/record.url?scp=85107482104&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s40122-021-00268-7
DO - https://doi.org/10.1007/s40122-021-00268-7
M3 - Article
C2 - 34091818
SN - 2193-8237
VL - 10
SP - 1189
EP - 1202
JO - Pain and Therapy
JF - Pain and Therapy
IS - 2
ER -