Study of Melatonin Compared to Placebo for Treating Adults With Chronic Low Back Pain

What this Trial Is About

Chronic low back pain LBP is a common cause of disability worldwide, with many patients experiencing ongoing pain and sleep difficulties. This trial is designed to evaluate the effect of melatonin compared to a placebo in adults with chronic LBP, aiming to better understand its potential for pain relief. The study is a randomized, triple-blind, placebo-controlled Phase 3 trial. Participants will receive either 10 mg of melatonin or a placebo daily for six weeks. The study compares these two groups to assess changes in pain intensity and other health outcomes. The treatment period is six weeks, after which participants will be followed up for up to six months to monitor longer-term effects. Throughout the study, participants will undergo assessments including pain intensity, disability related to back pain, global health, sleep quality, emotional functioning, and health-related quality of life. Researchers will also track sick leave days, healthcare usage, productivity losses, and any adverse events. These measurements will occur at baseline, after treatment, and during follow-ups at three and six months. The total involvement spans from the start of treatment through six months of follow-up.

Melatonin for Patients With Chronic Low Back Pain