The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial

Abstract Background Fibromyalgia is a chronic multidimensional pain disease with no curative treatment currently available. Its management relies on a multimodal approach involving pharmacologic and non-pharmacologic elements. Because a suggested factor in its etiology is a central sensitization phe...

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Autores principales:	Zuzana Javorcikova, Michel Dangoisse, Stéphane Nikis, Jean-Paul Lechat, Aline Gillain, Jean-François Fils, Philippe Van der Linden
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	S-ketamine Fibromyalgia Chronic pain Treatment N-Methyl-D-aspartate receptor Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/569b0e77782f454b8c7756c330a5a05b
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spelling	oai:doaj.org-article:569b0e77782f454b8c7756c330a5a05b2021-11-28T12:28:28ZThe place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial10.1186/s13063-021-05814-41745-6215https://doaj.org/article/569b0e77782f454b8c7756c330a5a05b2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05814-4https://doaj.org/toc/1745-6215Abstract Background Fibromyalgia is a chronic multidimensional pain disease with no curative treatment currently available. Its management relies on a multimodal approach involving pharmacologic and non-pharmacologic elements. Because a suggested factor in its etiology is a central sensitization phenomenon involving the N-methyl-D-aspartate receptor (NMDAR), NMDAR antagonists have been proposed as a treatment target. Ketamine and its levogyre form, S-ketamine, have been used to treat chronic pain for many years without consensus about their therapeutic efficiency. We aim to assess the efficacy of S-ketamine as a co-treatment for fibromyalgia. Methods This prospective, randomized, single-center, double-blind, parallel-group, dose-escalation trial will compare a co-treatment with S-ketamine (intervention) to a control treatment without S-ketamine (control). It will consist of two successive cohorts with 2:1 randomization ratio (S-ketamine at two different doses: control) with 105 participants in each cohort. The protocol follow-up time will be 12 weeks, including 3 visits for the treatment (week 0, week 2, and week 4) and 3 visits for follow-up (week 6, week 9, and week 12). Our primary outcome, pain relief and/or better patient function, will be assessed with the Brief Pain Inventory questionnaire. The statistical analysis will be performed on an intention-to-treat basis. If the primary outcome is reached at the end of follow-up in the first cohort with low-dose S-ketamine (0.2 mg/kg), the trial will end. If not, the trial will continue with the second cohort and high-dose S-ketamine (0.4 mg/kg). Discussion The challenge of our trial is the inclusion of a large number of participants in comparison to other trials involving ketamine or S-ketamine infusions for chronic pain management. The originality of our protocol is to include functionality in addition to pain relief as a primary outcome because these two endpoints are not linked in a linear way. For some patients, functional status is more important than pain relief. Trial registration EudraCT reference: 2020-000473-25, ClinicalTrials.gov : NCT04436250, first posted June 18, 2020; last updated July 21, 2020. Protocol version 2.2 issued on September 30, 2020, after a revision by the ethics committee. https://clinicaltrials.gov/ct2/show/NCT04436250Zuzana JavorcikovaMichel DangoisseStéphane NikisJean-Paul LechatAline GillainJean-François FilsPhilippe Van der LindenBMCarticleS-ketamineFibromyalgiaChronic painTreatmentN-Methyl-D-aspartate receptorMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	S-ketamine Fibromyalgia Chronic pain Treatment N-Methyl-D-aspartate receptor Medicine (General) R5-920
spellingShingle	S-ketamine Fibromyalgia Chronic pain Treatment N-Methyl-D-aspartate receptor Medicine (General) R5-920 Zuzana Javorcikova Michel Dangoisse Stéphane Nikis Jean-Paul Lechat Aline Gillain Jean-François Fils Philippe Van der Linden The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial
description	Abstract Background Fibromyalgia is a chronic multidimensional pain disease with no curative treatment currently available. Its management relies on a multimodal approach involving pharmacologic and non-pharmacologic elements. Because a suggested factor in its etiology is a central sensitization phenomenon involving the N-methyl-D-aspartate receptor (NMDAR), NMDAR antagonists have been proposed as a treatment target. Ketamine and its levogyre form, S-ketamine, have been used to treat chronic pain for many years without consensus about their therapeutic efficiency. We aim to assess the efficacy of S-ketamine as a co-treatment for fibromyalgia. Methods This prospective, randomized, single-center, double-blind, parallel-group, dose-escalation trial will compare a co-treatment with S-ketamine (intervention) to a control treatment without S-ketamine (control). It will consist of two successive cohorts with 2:1 randomization ratio (S-ketamine at two different doses: control) with 105 participants in each cohort. The protocol follow-up time will be 12 weeks, including 3 visits for the treatment (week 0, week 2, and week 4) and 3 visits for follow-up (week 6, week 9, and week 12). Our primary outcome, pain relief and/or better patient function, will be assessed with the Brief Pain Inventory questionnaire. The statistical analysis will be performed on an intention-to-treat basis. If the primary outcome is reached at the end of follow-up in the first cohort with low-dose S-ketamine (0.2 mg/kg), the trial will end. If not, the trial will continue with the second cohort and high-dose S-ketamine (0.4 mg/kg). Discussion The challenge of our trial is the inclusion of a large number of participants in comparison to other trials involving ketamine or S-ketamine infusions for chronic pain management. The originality of our protocol is to include functionality in addition to pain relief as a primary outcome because these two endpoints are not linked in a linear way. For some patients, functional status is more important than pain relief. Trial registration EudraCT reference: 2020-000473-25, ClinicalTrials.gov : NCT04436250, first posted June 18, 2020; last updated July 21, 2020. Protocol version 2.2 issued on September 30, 2020, after a revision by the ethics committee. https://clinicaltrials.gov/ct2/show/NCT04436250
format	article
author	Zuzana Javorcikova Michel Dangoisse Stéphane Nikis Jean-Paul Lechat Aline Gillain Jean-François Fils Philippe Van der Linden
author_facet	Zuzana Javorcikova Michel Dangoisse Stéphane Nikis Jean-Paul Lechat Aline Gillain Jean-François Fils Philippe Van der Linden
author_sort	Zuzana Javorcikova
title	The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial
title_short	The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial
title_full	The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial
title_fullStr	The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial
title_full_unstemmed	The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial
title_sort	place of s-ketamine in fibromyalgia treatment (eskefib): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/569b0e77782f454b8c7756c330a5a05b
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The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial

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