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Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).
Neurochirurgie. 2015 Mar; 61 Suppl 1:S109-16.N

Abstract

BACKGROUND

Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain.

MATERIALS AND METHODS

FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption.

TRIAL STATUS

Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112/115 patients have been enrolled. Preliminary results are expected to be published in 2015.

TRIAL REGISTRATION

Clinical trial registration information-URL: www.clinicaltrials.gov. Unique identifier NCT01628237.

Authors+Show Affiliations

N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France. Electronic address: manuel.roulaud@chu-poitiers.fr.Clinical Research Unit in Economics, Hôtel Dieu, 75004 Paris, France.Faculty of medicine and pharmacy, Poitiers University Hospital, 86000 Poitiers, France.Pain Evaluation and Treatment Centre, Lariboisière Hospital, 75010 Paris, France.Pain Evaluation and Treatment Centre, Poitiers University Hospital, 86000 Poitiers, France.Department of Neurosurgery, Reims University Hospital, 51092 Reims, France.Pain Evaluation and Treatment Centre, Brest University Hospital, 29200 Brest, France.Department of Neurosurgery, Colmar Hospital, 68024 Colmar, France.Department of Neurosurgery, Nantes University Hospital, 44093 Nantes, France.Department of Neurosurgery, Sainte-Anne Hospital, AP-HP, 75014 Paris, France.Department of Neurosurgery, Nice University Hospital, 06003 Nice, France.Department of Neurosurgery, Nice University Hospital, 06003 Nice, France.Department of Neurosurgery, Lille University Hospital, 59037 Lille, France.Department of Neurosurgery, Lille University Hospital, 59037 Lille, France.Department of Neurosurgery, Bordeaux University Hospital, 33076 Bordeaux, France.Department of Neurosurgery, Bordeaux University Hospital, 33076 Bordeaux, France.Department of Neurosurgery, Limoges University Hospital, 87042 Limoges, France.Department of Neurosurgery, Limoges University Hospital, 87042 Limoges, France.Department of Neurosurgery, Lyon University Hospital, 69677 Lyon, France.Department of Neurosurgery, Lyon University Hospital, 69677 Lyon, France.Department of Neurosurgery, Lyon University Hospital, 69677 Lyon, France.Department of Neurosurgery, Caen University Hospital, 14000 Caen, France.Department of Neurosurgery, Caen University Hospital, 14000 Caen, France.Department of Neurosurgery, AP-HM, Timone Hospital, 13385 Marseille, France.Department of Neurosurgery, Toulouse University Hospital, 31000 Toulouse, France.Internal Medicine/Infectious and Tropical Diseases Department, Poitiers University Hospital, 86000 Poitiers, France.Department of Rheumatology, Poitiers University Hospital, 86000 Poitiers, France.Department of Rheumatology, Poitiers University Hospital, 86000 Poitiers, France.N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France; Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25456442

Citation

Roulaud, M, et al. "Multicolumn Spinal Cord Stimulation for Significant Low Back Pain in Failed Back Surgery Syndrome: Design of a National, Multicentre, Randomized, Controlled Health Economics Trial (ESTIMET Study)." Neuro-Chirurgie, vol. 61 Suppl 1, 2015, pp. S109-16.
Roulaud M, Durand-Zaleski I, Ingrand P, et al. Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). Neurochirurgie. 2015;61 Suppl 1:S109-16.
Roulaud, M., Durand-Zaleski, I., Ingrand, P., Serrie, A., Diallo, B., Peruzzi, P., Hieu, P. D., Voirin, J., Raoul, S., Page, P., Fontaine, D., Lantéri-Minet, M., Blond, S., Buisset, N., Cuny, E., Cadenne, M., Caire, F., Ranoux, D., Mertens, P., ... Rigoard, P. (2015). Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). Neuro-Chirurgie, 61 Suppl 1, S109-16. https://doi.org/10.1016/j.neuchi.2014.10.105
Roulaud M, et al. Multicolumn Spinal Cord Stimulation for Significant Low Back Pain in Failed Back Surgery Syndrome: Design of a National, Multicentre, Randomized, Controlled Health Economics Trial (ESTIMET Study). Neurochirurgie. 2015;61 Suppl 1:S109-16. PubMed PMID: 25456442.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). AU - Roulaud,M, AU - Durand-Zaleski,I, AU - Ingrand,P, AU - Serrie,A, AU - Diallo,B, AU - Peruzzi,P, AU - Hieu,P D, AU - Voirin,J, AU - Raoul,S, AU - Page,P, AU - Fontaine,D, AU - Lantéri-Minet,M, AU - Blond,S, AU - Buisset,N, AU - Cuny,E, AU - Cadenne,M, AU - Caire,F, AU - Ranoux,D, AU - Mertens,P, AU - Naous,H, AU - Simon,E, AU - Emery,E, AU - Gadan,B, AU - Regis,J, AU - Sol,J-C, AU - Béraud,G, AU - Debiais,F, AU - Durand,G, AU - Guetarni Ging,F, AU - Prévost,A, AU - Brandet,C, AU - Monlezun,O, AU - Delmotte,A, AU - d'Houtaud,S, AU - Bataille,B, AU - Rigoard,P, Y1 - 2014/11/20/ PY - 2013/09/16/received PY - 2014/09/24/revised PY - 2014/10/04/accepted PY - 2014/12/3/entrez PY - 2014/12/3/pubmed PY - 2015/12/15/medline KW - Douleurs lombaires KW - Douleurs neuropathiques KW - Failed back surgery syndrome KW - Health economics evaluation KW - Lombo-radiculalgies postopératoires KW - Low back pain KW - Neuropathic pain KW - Randomized controlled trial KW - Spinal cord stimulation KW - Stimulation médullaire épidurale KW - Étude randomisée contrôlée KW - Évaluation médico-économique SP - S109 EP - 16 JF - Neuro-Chirurgie JO - Neurochirurgie VL - 61 Suppl 1 N2 - BACKGROUND: Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. MATERIALS AND METHODS: FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption. TRIAL STATUS: Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112/115 patients have been enrolled. Preliminary results are expected to be published in 2015. TRIAL REGISTRATION: Clinical trial registration information-URL: www.clinicaltrials.gov. Unique identifier NCT01628237. SN - 1773-0619 UR - https://www.unboundmedicine.com/medline/citation/25456442/Multicolumn_spinal_cord_stimulation_for_significant_low_back_pain_in_failed_back_surgery_syndrome:_design_of_a_national_multicentre_randomized_controlled_health_economics_trial__ESTIMET_Study__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0028-3770(14)00261-6 DB - PRIME DP - Unbound Medicine ER -