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Study on Melatonin for Patients with Chronic Back Pain

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of chronic back pain and aims to explore a potential treatment using Melatonin. Melatonin is a substance that is naturally produced in the body and is often associated with regulating sleep. In this study, participants will take a 10 mg dose of Melatonin in tablet form once daily before bedtime for a period of six weeks. The study will compare the effects of Melatonin with a placebo, which looks identical to the Melatonin tablet but does not contain any active ingredients.

The purpose of the study is to determine if Melatonin can help reduce the intensity of pain experienced by individuals with chronic back pain. Participants will be randomly assigned to receive either the Melatonin tablets or the placebo tablets. Neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This approach is known as a double-blind study and helps ensure that the results are not biased.

Throughout the six-week study period, participants will be asked to report their pain levels and any changes they experience. The main focus will be on the average pain intensity over the past week, measured on a scale from 0 (no pain) to 10 (worst imaginable pain). The study will also look at other factors such as any improvements in back pain-related disability, overall health, and sleep quality. By the end of the study, researchers hope to determine whether Melatonin is more effective than the placebo in reducing pain and improving the quality of life for those with chronic back pain.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Trial initiation
Upon joining the trial, participants will be randomly assigned to receive either melatonin or a placebo. The placebo is a tablet that looks identical to the melatonin tablet but does not contain the active substance.
The trial is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving melatonin or placebo.
Step 2
Medication administration
Participants will take one tablet of melatonin 10 mg or placebo once daily before bedtime.
This treatment will continue for a duration of 6 weeks.
Step 3
Pain assessment
Pain intensity will be assessed weekly using a Numeric Rating Scale (NRS) from 0 to 10, where 0 means 'no pain' and 10 means 'worst imaginable pain'.
The primary focus is on the average back pain intensity over the past 7 days, with assessments conducted at the start and end of the 6-week period.
Step 4
Secondary assessments
Additional assessments will include the trajectory of weekly pain scores, the number of participants with significant improvement, and back pain-related disability using the Roland Morris Disability Questionnaire.
Global Perceived Effect will be evaluated by asking participants to compare their back pain at the end of the trial to when they started.
Step 5
Health and insomnia evaluation
Physical and mental health will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health questionnaire.
Insomnia symptoms will be evaluated using the Insomnia Severity Index, which measures the severity of insomnia symptoms.
Step 6
Pain sensitivity measurement
Pain sensitivity will be measured using a handheld device called an algometer, which applies pressure to specific muscles to determine pain thresholds.
Measurements will be taken at the right erector spinae muscle and the left upper trapezius muscle.

Who can join the trial?

6 criteria

Must be between 18 and 64 years old.
Must have had back pain for 3 months or longer.
Back pain should be present on most days or every day in the past 3 months. This will be checked by asking: "In the past 3 months, how often did you have back pain?" with options like "never," "some days," "most days," or "every day."
Back pain should limit life or work activities on some days, most days, or every day in the past 3 months. This will be checked by asking: "In the past 3 months, how often did your back pain limit your life or work activities?" with options like "never," "some days," "most days," or "every day."
Average pain intensity should be 4 or more on a scale from 0 to 10 in the past 7 days, where 0 means "no pain" and 10 means "worst imaginable pain."
All women who can have children must use safe birth control methods like a spiral, birth control pills, contraceptive patch, contraceptive vaginal ring, or gestagen injections for 3 weeks before and 1 week after the trial. If a woman's normal lifestyle includes not having sex, she does not need to use birth control but must agree to remain abstinent during the trial. A woman is considered unable to have children if she has been sterilized, had a hysterectomy (removal of the uterus), had both ovaries removed, or is postmenopausal. A woman is considered postmenopausal if she has not had vaginal bleeding for 1 year, as reported by her.

Who cannot join the trial?

8 criteria

Patients who are currently taking other medications that might interfere with the study treatment.
Individuals with a history of allergic reactions to melatonin or similar substances.
Participants who have been diagnosed with severe mental health disorders, such as severe depression or anxiety.
People with significant liver or kidney disease, as these organs help process medications.
Women who are pregnant or breastfeeding, as the effects on the baby are not known.
Individuals who have participated in another clinical trial within the last 30 days.
Patients with a history of substance abuse, which means using drugs or alcohol in a harmful way.
Anyone with a medical condition that the study doctors believe would make it unsafe to participate.

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Investigated drugs

Melatonin is a medication being studied for its potential to help reduce pain intensity in people with chronic back pain. In this trial, participants take Melatonin once daily before bedtime for six weeks. The goal is to see if Melatonin can provide better pain relief compared to not taking any active medication.

Melatonin

What is already known about the treatment

Melatonin – Melatonin is administered orally in the form of tablets, typically taken once daily before bedtime. It is currently being studied in clinical trials for its potential benefits in managing chronic back pain. The main therapeutic indication being explored is the reduction of pain intensity in individuals suffering from chronic back pain. At the molecular level, melatonin works by regulating the sleep-wake cycle and has antioxidant properties, which may contribute to its pain-relieving effects. It is classified pharmacologically as a hormone and is commonly used for sleep disorders, but its role in pain management is still under investigation.

Investigated diseases

Chronic Back Pain – Chronic back pain is a persistent pain that occurs in the back, typically lasting for more than three months. It can result from various causes, including muscle or ligament strain, bulging or ruptured disks, arthritis, or skeletal irregularities. The pain may be continuous or intermittent and can vary in intensity from a dull ache to a sharp or stabbing sensation. It often worsens with movement or prolonged periods of sitting or standing. Over time, chronic back pain can lead to decreased mobility and flexibility, affecting daily activities and quality of life.