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Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial

BACKGROUND: Neuropathic pain (NP), a complication of several conditions (eg, diabetic neuropathy and varicella zoster), is a common challenging problem, and there is a growing need to develop safe and effective nonopioid treatments. Sleep disturbance is commonly associated with NP because pain inten...

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Autores principales: Gilron, Ian, Tu, Dongsheng, Holden, Ronald R, Moulin, Dwight E, Duggan, Scott, Milev, Roumen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557986/
https://www.ncbi.nlm.nih.gov/pubmed/36170003
http://dx.doi.org/10.2196/40025
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author Gilron, Ian
Tu, Dongsheng
Holden, Ronald R
Moulin, Dwight E
Duggan, Scott
Milev, Roumen
author_facet Gilron, Ian
Tu, Dongsheng
Holden, Ronald R
Moulin, Dwight E
Duggan, Scott
Milev, Roumen
author_sort Gilron, Ian
collection PubMed
description BACKGROUND: Neuropathic pain (NP), a complication of several conditions (eg, diabetic neuropathy and varicella zoster), is a common challenging problem, and there is a growing need to develop safe and effective nonopioid treatments. Sleep disturbance is commonly associated with NP because pain intensity in NP conditions is often worse at night. The pineal hormone melatonin has been shown to reduce pain in both preclinical and clinical settings, in addition to multiple trials demonstrating efficacy for primary insomnia and delayed sleep phase syndrome. OBJECTIVE: We propose to conduct a clinical trial to evaluate the efficacy and safety of melatonin for NP. METHODS: Using a double-blind, placebo-controlled, crossover design, 30 adults with NP will be randomly allocated to one of two sequences of treatment with melatonin and placebo. During each of the two treatment periods, participants will take capsules containing melatonin or placebo for 4 weeks, followed by a 7-day washout period. The primary outcome will be mean daily pain intensity (scored 0-10) at maximally tolerated doses (MTDs) during each period. Secondary outcomes, assessed at MTDs, will include global improvement, adverse events, mood, and quality of life. RESULTS: This trial was registered in the International Standard Randomized Controlled Trial registry May 4, 2022 (ISRCTN #16215617), attained conditional ethics approval May 9, 2022 (Queen’s University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-387-22), and recruitment is set to start August 2022. CONCLUSIONS: This trial will provide rigorous evidence comparing the efficacy of melatonin to that of placebo in the treatment of NP. TRIAL REGISTRATION: ISRCTN Registry 16215617; https://www.isrctn.com/ISRCTN16215617 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40025
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spelling pubmed-95579862022-10-14 Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial Gilron, Ian Tu, Dongsheng Holden, Ronald R Moulin, Dwight E Duggan, Scott Milev, Roumen JMIR Res Protoc Protocol BACKGROUND: Neuropathic pain (NP), a complication of several conditions (eg, diabetic neuropathy and varicella zoster), is a common challenging problem, and there is a growing need to develop safe and effective nonopioid treatments. Sleep disturbance is commonly associated with NP because pain intensity in NP conditions is often worse at night. The pineal hormone melatonin has been shown to reduce pain in both preclinical and clinical settings, in addition to multiple trials demonstrating efficacy for primary insomnia and delayed sleep phase syndrome. OBJECTIVE: We propose to conduct a clinical trial to evaluate the efficacy and safety of melatonin for NP. METHODS: Using a double-blind, placebo-controlled, crossover design, 30 adults with NP will be randomly allocated to one of two sequences of treatment with melatonin and placebo. During each of the two treatment periods, participants will take capsules containing melatonin or placebo for 4 weeks, followed by a 7-day washout period. The primary outcome will be mean daily pain intensity (scored 0-10) at maximally tolerated doses (MTDs) during each period. Secondary outcomes, assessed at MTDs, will include global improvement, adverse events, mood, and quality of life. RESULTS: This trial was registered in the International Standard Randomized Controlled Trial registry May 4, 2022 (ISRCTN #16215617), attained conditional ethics approval May 9, 2022 (Queen’s University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-387-22), and recruitment is set to start August 2022. CONCLUSIONS: This trial will provide rigorous evidence comparing the efficacy of melatonin to that of placebo in the treatment of NP. TRIAL REGISTRATION: ISRCTN Registry 16215617; https://www.isrctn.com/ISRCTN16215617 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40025 JMIR Publications 2022-09-28 /pmc/articles/PMC9557986/ /pubmed/36170003 http://dx.doi.org/10.2196/40025 Text en ©Ian Gilron, Dongsheng Tu, Ronald R Holden, Dwight E Moulin, Scott Duggan, Roumen Milev. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.09.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Gilron, Ian
Tu, Dongsheng
Holden, Ronald R
Moulin, Dwight E
Duggan, Scott
Milev, Roumen
Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial
title Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial
title_full Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial
title_fullStr Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial
title_full_unstemmed Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial
title_short Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial
title_sort melatonin for neuropathic pain: protocol for a double-blind, randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557986/
https://www.ncbi.nlm.nih.gov/pubmed/36170003
http://dx.doi.org/10.2196/40025
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