Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-20
Brief Title:
Melatonin fOr CHronic bAck Pain The MOCHA Trial
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Melatonin fOr CHronic bAck Pain The MOCHA Trial A Randomized Double Blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 worldwidePain 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 ie 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 065 95CI 034 to 096 of Melatonin doses ranging between 3-10 mg before sleep compared with placebo in reducing pain in patients with non-musculoskeletal chronic pain eg 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 ie 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 065 95CI 034 to 096 of Melatonin doses ranging between 3-10 mg before sleep compared with placebo in reducing pain in patients with non-musculoskeletal chronic pain eg 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 ie 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 ie pressure pain threshold and objective sleep metrics as well as effect-modification of presenceabsence 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 ie 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 ie pressure pain threshold and objective sleep metrics as well as effect-modification of presenceabsence of comorbid insomnia
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None