Clinical trial NCT06859957: Melatonin for Patients with Chronic Low Back Pain
Official title: Melatonin for Patients with Chronic Low Back Pain - a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Low-back Pain (cLBP)
Keywords: Chronic low back pain
Melatonin
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Change in low back pain intensity
timeFrame: from baseline to end of treatment at 6 weeks
Secondary outcomes:
measure: Back pain-related disability (RMDQ)
timeFrame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
measure: Global perceived effect score
timeFrame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
measure: Physical and mental health measured using the PROMIS Global Health
timeFrame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
measure: Health related quality of life measured using the EQ-5D-5L
timeFrame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
measure: Insomnia measured using the Insomnia Severity Index
timeFrame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
measure: Self-reported number of days with sick leave
timeFrame: baseline to 3 months and 6 months follow-up
measure: Emotional functioning using the Beck Depression Inventory (BDI)
timeFrame: baseline to end of treatment at 6 weeks
measure: Pain-related anxiety measured using the Pain Anxiety Symptoms Scale
timeFrame: baseline to end of treatment at 6 weeks
measure: Neuropathic pain measured using PainDETECT
timeFrame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
measure: Productivity losses measured using iMTA Productivity Cost Questionnaire
timeFrame: baseline to 3 months and 6 months follow-up
measure: Direct costs of medical care measured using iMCQ Medical Consumption Questionnaire
timeFrame: baseline to 3 months and 6 months follow-up
measure: Adverse events
timeFrame: baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up
Other outcomes:
measure: Activity patterns measured using a GENEActiv activity tracker
timeFrame: 7 days during treatment period
measure: Sleep reports measured using a GENEActiv activity tracker
timeFrame: 7 days during treatment period
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
References: