Melatonin for Patients With Chronic Low Back Pain
ConditionChronic Low-back Pain (cLBP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBart Koes
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Melatonin 10 mg
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Bart Koes
Lead sponsor
Erasmus Medical Center
Sponsor institution
Source ClinicalTrials.gov