Melatonin and chronic pain (DREAM-CP) V1
Research type
Research Study
Full title
Double blind randomised controlled trial of exogenous administration of melatonin in chronic pain (DREAM-CP)
IRAS ID
255612
Contact name
Saravanakumar Kanakarajan
Contact email
Sponsor organisation
University of Aberdeen
Eudract number
2018-004048-50
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Research Summary
Chronic pain affects ~20% of adults. Pain and sleep are inextricably linked: individuals with persistent pain experience poor sleep quality which worsens as pain intensity increases. Improvements in sleep can also improve pain. Endogenous pineal melatonin is regulated by light and regulates sleep. Exogenous melatonin also has analgesic and anxiolytic effects, however the effect of melatonin on sleep/chronic pain is unclear. We will investigate the efficacy of exogenous melatonin on sleep and pain in patients with severe chronic pain in a double blind, randomised, placebo controlled, cross-over trial in a tertiary referral pain management clinic. Patients (n=60) with an average pain rating of 7 out of 10 or higher on the brief pain inventory visual analogue scale (BPI) will be randomised to receive 2mg melatonin or placebo, then crossover to the opposite treatment, 6 weeks each arm. the primary outcome measure is sleep disturbance. Secondary outcome measures will include average pain intensity, melatonin/6-hydroxymelatonin levels, psychomotor vigilance, objective sleep measures and real time pain/fatigue scores. It is hoped that melatonin may provide an inexpensive and safe therapy for chronic pain related sleep problems and may also benefit pain.
Summary of Results
Sleep disturbance is a major issue for patients with chronic pain. Melatonin is used to treat insomnia but the the effect of melatonin in patients with sleep issues caused by severe chronic pain was not known.
We used a trial design called a crossover trial where participants are randomised (like tossing a coin) to be treated either with melatonin or a dummy drug (placebo) for 6 weeks, followed by a rest period, then swapping over. This means half the people taking part got melatonin then placebo, and half got placebo then melatonin. Sixty people took part.
We asked participants to complete questionnaires about their sleep and found that sleep was improved after 3 weeks treatment with melatonin compared to placebo but by 6 weeks, there was no difference.
Melatonin treatment improved sleep in the short term and given its favourable safety profile it may be useful for some patients with chronic pain.REC name
HSC REC A
REC reference
19/NI/0007
Date of REC Opinion
8 Feb 2019
REC opinion
Further Information Favourable Opinion