Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-03-08 @ 4:11 AM
Study NCT ID:
NCT06476392
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin for CHronic BAck Pain (The MOCHA Trial)
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
Melatonin for CHronic BAck Pain (The MOCHA Trial): a Randomized, Double Blind, Placebo-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOCHA
Brief Summary:
According to the World Health Organization (WHO) Global Burden of Disease study, back pain is one of the conditions impacting disability the most worldwide.Pain medication use in patients with chronic back pain is substantial, but the efficacy of commonly used analgesics such as paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants and opioids compared with placebo are modest, with effects typically less than 10 points on a 0-100 pain scale. Importantly, these analgesics are not harmless due to gastrointestinal and cardiovascular side-effects (NSAIDs) and risk of dependency and addiction (opioids). This often leave general practitioners without good treatment options for many patients with chronic low back pain.
More than half of patients with chronic back pain also have sleep problems (i.e. insomnia), which negatively affect daily function, general health and quality of life. Research suggest that insomnia has negative effects on pain processing, and although the relationship between pain and insomnia is bi-directional, insomnia is considered to be a stronger predictor of pain than pain for the development of insomnia.
Melatonin is a widely available drug worldwide, and well known for its use in people with sleep disorders and jetlag. Melatonin is a naturally occurring hormone excreted by the pineal gland that is part of regulating the circadian rhythm (sleep-wake patterns). Unlike commonly used drugs to treat back pain, the safety profile of melatonin is favorable with no adverse events of major clinical significance reported in the treatment of sleep disorders. In recent years, some preliminary studies have showed a promising effect of Melatonin for treatments of pain. A meta-analysis reported an effect size of 0.65 (95%CI 0.34 to 0.96) of Melatonin (doses ranging between 3-10 mg before sleep) compared with placebo in reducing pain in patients with non-musculoskeletal chronic pain (e.g. migraine, irritable bowel syndrome, burning mouth syndrome), suggesting that Melatonin could potentially also be a valid treatment option for chronic musculoskeletal pain patients.
More than half of patients with chronic back pain also have sleep problems (i.e. insomnia), which negatively affect daily function, general health and quality of life. Research suggest that insomnia has negative effects on pain processing, and although the relationship between pain and insomnia is bi-directional, insomnia is considered to be a stronger predictor of pain than pain for the development of insomnia.
Melatonin is a widely available drug worldwide, and well known for its use in people with sleep disorders and jetlag. Melatonin is a naturally occurring hormone excreted by the pineal gland that is part of regulating the circadian rhythm (sleep-wake patterns). Unlike commonly used drugs to treat back pain, the safety profile of melatonin is favorable with no adverse events of major clinical significance reported in the treatment of sleep disorders. In recent years, some preliminary studies have showed a promising effect of Melatonin for treatments of pain. A meta-analysis reported an effect size of 0.65 (95%CI 0.34 to 0.96) of Melatonin (doses ranging between 3-10 mg before sleep) compared with placebo in reducing pain in patients with non-musculoskeletal chronic pain (e.g. migraine, irritable bowel syndrome, burning mouth syndrome), suggesting that Melatonin could potentially also be a valid treatment option for chronic musculoskeletal pain patients.
Detailed Description:
The aim of this randomized double-blind placebo controlled clinical superiority trial is to investigate if daily treatment with Melatonin 10 mg once daily before bedtime for 6 weeks is superior compared with placebo in improving pain intensity assessed at 6 weeks after treatment initiation in patients with chronic back pain.
The primary objective is to compare the effect of the drug Melatonin, relative to placebo, on difference in change in pain intensity (i.e. average pain intensity past 7 days) measured on a 0-10 NRS scale, from baseline to 6 weeks in patients with chronic back pain.
Secondary objectives are to compare the effect of the drug Melatonin, relative to placebo, on 1) pain-related disability, 2) Global Perceived Effect (GPE), 3) insomnia severity, and 4) health-related quality of life. Furthermore, pain trajectory (0 to 6 weeks) and responder indices from baseline to 6 weeks will be compared between the treatment groups for the primary outcome.
Explorative objectives are to investigate changes in pain sensitivity (i.e. pressure pain threshold) and objective sleep metrics as well as effect-modification of presence/absence of comorbid insomnia.
The primary objective is to compare the effect of the drug Melatonin, relative to placebo, on difference in change in pain intensity (i.e. average pain intensity past 7 days) measured on a 0-10 NRS scale, from baseline to 6 weeks in patients with chronic back pain.
Secondary objectives are to compare the effect of the drug Melatonin, relative to placebo, on 1) pain-related disability, 2) Global Perceived Effect (GPE), 3) insomnia severity, and 4) health-related quality of life. Furthermore, pain trajectory (0 to 6 weeks) and responder indices from baseline to 6 weeks will be compared between the treatment groups for the primary outcome.
Explorative objectives are to investigate changes in pain sensitivity (i.e. pressure pain threshold) and objective sleep metrics as well as effect-modification of presence/absence of comorbid insomnia.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: