Melatonin for Patients With Chronic Low Back Pain

Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial

Low back pain is one of the conditions causing more disability worldwide. The use of pain medications is substantial in patients with chronic LBP. But the efficacy of commonly used analgesics is modest. More than half of patients with chronic LBP also has sleep problems. In recent years, some preliminary studies have shown a promising effect of melatonin for the treatment of pain.

The objective of this study is to investigate the efficacy of melatonin, relative to placebo, in patients with chronic LBP.

Inclusion Criteria:

• age 18-65
• understand and write Dutch
• LBP for 3 months or longer
• LBP must be present on 'most days' or 'every day' within the past 3 months
• LBP must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months
• average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days

Exclusion Criteria:

• LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis
• Radiating pain into the leg that goes further (down) than the knee
• Inflammatory/autoimmune arthritis
• Severe physical or psychiatric co-morbidities
• Contraindications to melatonin