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Recruiting NCT06859957

Melatonin for Patients With Chronic Low Back Pain

Phase III Interventional Chronic Low-back Pain (cLBP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Melatonin 10 mg, Placebo.
Who it may be relevant to
Registry conditions: Chronic Low-back Pain (cLBP). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Melatonin 10 mg
    10 mg melatonin daily for a period of 6 weeks
  • Drug Placebo
    Daily placebo for a period of 6 weeks

Primary outcome measures

  • Change in low back pain intensity [Time frame: from baseline to end of treatment at 6 weeks]
Secondary outcome measures (12)
  • Back pain-related disability (RMDQ) [Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up]
  • Global perceived effect score [Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up]
  • Physical and mental health measured using the PROMIS Global Health [Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up]
  • Health related quality of life measured using the EQ-5D-5L [Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up]
  • Insomnia measured using the Insomnia Severity Index [Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up]
  • Self-reported number of days with sick leave [Time frame: baseline to 3 months and 6 months follow-up]
  • Emotional functioning using the Beck Depression Inventory (BDI) [Time frame: baseline to end of treatment at 6 weeks]
  • Pain-related anxiety measured using the Pain Anxiety Symptoms Scale [Time frame: baseline to end of treatment at 6 weeks]
  • Neuropathic pain measured using PainDETECT [Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up]
  • Productivity losses measured using iMTA Productivity Cost Questionnaire [Time frame: baseline to 3 months and 6 months follow-up]
  • Direct costs of medical care measured using iMCQ Medical Consumption Questionnaire [Time frame: baseline to 3 months and 6 months follow-up]
  • Adverse events [Time frame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Erasmus MC — Rotterdam

Identifiers

NCT: NCT06859957 · PaNaMa 11825 · 2024-514769-20-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗