Evaluation of Melatonin Efficacy in Chronic Low Back Pain: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

The primary objective of this randomized, double-blind, placebo-controlled clinical superiority trial is to evaluate the efficacy of **melatonin** in reducing pain intensity in patients with **chronic low back pain**. The study aims to determine if a daily dose of 10 mg melatonin, administered once daily before bedtime over a period of 6 weeks, is superior to placebo in alleviating pain intensity, as assessed at the 6-week mark following treatment initiation. This investigation is clinically relevant as it seeks to provide evidence for an alternative therapeutic option for managing chronic low back pain, a condition that significantly impacts quality of life and functional capacity.

The clinical trial focuses on individuals diagnosed with **chronic low back pain**. The study population includes both male and female participants aged between 18 and 65 years. Participants are required to have experienced low back pain for a duration of three months or longer, with the pain present on most days within the past three months. Additionally, the pain must have limited their life or work activities during this period, and the average pain intensity should be 4 or higher on a 0-10 numerical rating scale in the past seven days. The sponsor has not provided information regarding the total number of participants. The trial does not involve a vulnerable population, and no specific lifestyle considerations such as diet or physical activity are highlighted. Participants were selected based on the inclusion criteria, ensuring a focus on those significantly impacted by chronic low back pain.

The clinical trial is designed as a **randomized**, **double-blind**, placebo-controlled study to evaluate the efficacy of **melatonin** in patients with **chronic low back pain**. The primary objective is to determine if a daily dose of 10 mg melatonin, administered orally before bedtime for a duration of six weeks, is superior to placebo in reducing pain intensity. The trial will measure the change in pain intensity using a 0-10 numerical rating scale (NRS) from baseline to the end of the treatment period. The study is expected to commence recruitment on January 2, 2025, and conclude by January 2, 2027.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age (18 to 65 years), duration and impact of low back pain, and baseline pain intensity. Eligible participants will be randomized to receive either melatonin or placebo. Follow-up visits will occur at regular intervals to monitor adherence, collect data on pain intensity, and assess any adverse events. The end-of-study visit will evaluate the primary endpoint and gather final data.

The expected length of participant involvement is six weeks, corresponding to the treatment duration. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of significant adverse events. The trial is structured to ensure rigorous data collection and analysis, maintaining the integrity of the double-blind design throughout the study period.

The clinical trial involves the administration of **Melatonin** as the experimental medication. The product used is "Melatonine Tiofarma 5 mg tabletten," which is formulated as a tablet. Each tablet contains 5 mg of the active substance, melatonin. The route of administration is oral, with a dosage regimen of 10 mg once daily, administered before bedtime. The treatment duration is set for a period of 6 weeks. The melatonin tablets are manufactured by TIOFARMA BV and are identified by the marketing authorization number RVG 120773. The maximum daily dose and total dose amount are both 10 mg, ensuring adherence to the specified dosing schedule.

The trial also includes a **placebo** as a non-experimental treatment to serve as a comparator. The placebo is designed to match the experimental medication in appearance and administration route, ensuring blinding in this double-blind study. The placebo is composed of lactose monohydrate, which is an inactive substance. The placebo is administered orally, once daily before bedtime, for the same duration of 6 weeks. This design allows for the assessment of the efficacy of melatonin in comparison to the placebo in patients with chronic low back pain.

Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment protocol. The study aims to evaluate the superiority of melatonin over placebo in reducing pain intensity in patients with chronic low back pain, with assessments conducted at the end of the 6-week treatment period.

Efficacy in the clinical trial titled "Melatonin for patients with chronic low back pain (MELBACK) - a randomized placebo-controlled trial" will be assessed by evaluating the primary endpoint, which is the between-group difference in change in pain intensity. This will be measured using a 0-10 Numeric Rating Scale (NRS) for average pain intensity over the past 7 days. The assessment will occur from baseline to 6 weeks after treatment initiation in patients with chronic low back pain (LBP). The trial aims to determine if daily treatment with **melatonin** 10 mg once daily before bedtime for 6 weeks is superior to placebo in improving pain intensity. The primary endpoint will be collected and analyzed at the 6-week mark to determine the efficacy of the treatment. The trial is designed as a randomized, double-blind, placebo-controlled clinical superiority trial, ensuring rigorous evaluation of the treatment's effectiveness.