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Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial.
Ian Gilron1, Dongsheng Tu2, Ronald R Holden2
1Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada.
JMIR Research Protocols
|September 28, 2022
Summary
This clinical trial will assess melatonin as a potential nonopioid treatment for neuropathic pain (NP). Researchers will compare melatonin
Area of Science:
- Neurology
- Pain Management
- Sleep Medicine
Background:
- Neuropathic pain (NP) is a challenging condition often accompanied by sleep disturbances.
- Current treatments for NP have limitations, driving the need for safe, nonopioid alternatives.
- Melatonin, a pineal hormone, has demonstrated pain-reducing effects and efficacy in sleep disorders.
Purpose of the Study:
- To evaluate the efficacy and safety of melatonin for treating neuropathic pain.
- To investigate melatonin's potential as a nonopioid therapeutic option for NP.
Main Methods:
- A double-blind, placebo-controlled, crossover clinical trial involving 30 adults with NP.
- Participants will receive melatonin and placebo for 4-week periods, separated by a 7-day washout.
- Primary outcome: mean daily pain intensity; Secondary outcomes: global improvement, adverse events, mood, and quality of life.
Main Results:
- The trial is registered (ISRCTN #16215617) with ethics approval obtained.
- Recruitment is scheduled to commence in August 2022.
- Data on pain intensity, mood, and quality of life will be collected.
Conclusions:
- This study aims to provide robust evidence on melatonin's effectiveness for NP.
- Results will inform the use of melatonin as a potential treatment for neuropathic pain.
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