Melatonin for Patients With Chronic Low Back Pain (MELBACK)

Bart Koes

Status and phase: Enrolling; Phase 3

Conditions: Chronic Low-back Pain (cLBP)

Treatments: Drug: Placebo; Drug: Melatonin 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06859957

2024-514769-20-00 (EU Trial (CTIS) Number)

PaNaMa 11825

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Melatonin

Experimental group

Description:

10mg of melatonin daily for a period of 6 weeks

Treatment:

Drug: Melatonin 10 mg