Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial
BackgroundNeuropathic 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...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-09-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/9/e40025 |
| _version_ | 1797734718466162688 |
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| author | Ian Gilron Dongsheng Tu Ronald R Holden Dwight E Moulin Scott Duggan Roumen Milev |
| author_facet | Ian Gilron Dongsheng Tu Ronald R Holden Dwight E Moulin Scott Duggan Roumen Milev |
| author_sort | Ian Gilron |
| collection | DOAJ |
| description |
BackgroundNeuropathic 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.
ObjectiveWe propose to conduct a clinical trial to evaluate the efficacy and safety of melatonin for NP.
MethodsUsing 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.
ResultsThis 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.
ConclusionsThis trial will provide rigorous evidence comparing the efficacy of melatonin to that of placebo in the treatment of NP.
Trial RegistrationISRCTN Registry 16215617; https://www.isrctn.com/ISRCTN16215617
International Registered Report Identifier (IRRID)PRR1-10.2196/40025 |
| first_indexed | 2024-03-12T12:48:25Z |
| format | Article |
| id | doaj.art-6cfebd838458482392f3edb153b91687 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:48:25Z |
| publishDate | 2022-09-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-6cfebd838458482392f3edb153b916872023-08-28T23:08:38ZengJMIR PublicationsJMIR Research Protocols1929-07482022-09-01119e4002510.2196/40025Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled TrialIan Gilronhttps://orcid.org/0000-0002-5293-8792Dongsheng Tuhttps://orcid.org/0000-0003-4842-2184Ronald R Holdenhttps://orcid.org/0000-0002-9070-2510Dwight E Moulinhttps://orcid.org/0000-0001-9902-2418Scott Dugganhttps://orcid.org/0000-0003-0161-2706Roumen Milevhttps://orcid.org/0000-0001-6884-171X BackgroundNeuropathic 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. ObjectiveWe propose to conduct a clinical trial to evaluate the efficacy and safety of melatonin for NP. MethodsUsing 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. ResultsThis 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. ConclusionsThis trial will provide rigorous evidence comparing the efficacy of melatonin to that of placebo in the treatment of NP. Trial RegistrationISRCTN Registry 16215617; https://www.isrctn.com/ISRCTN16215617 International Registered Report Identifier (IRRID)PRR1-10.2196/40025https://www.researchprotocols.org/2022/9/e40025 |
| spellingShingle | Ian Gilron Dongsheng Tu Ronald R Holden Dwight E Moulin Scott Duggan Roumen Milev Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial JMIR Research Protocols |
| 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 |
| url | https://www.researchprotocols.org/2022/9/e40025 |
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