NCT06859957

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

January 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 22, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

January 31, 2025

Last Update Submit

August 18, 2025

Conditions

Chronic Low-back Pain (cLBP)

Keywords

Chronic low back painMelatonin

Outcome Measures

Primary Outcomes (1)

  • Change in low back pain intensity

    Change in low back pain intensity (average pain intensity past 7 days), measured on a 0-10 Numeric Rating Scale (NRS) where 0 means no pain and 10 means worst pain imaginable, from baseline to 6 weeks

    from baseline to end of treatment at 6 weeks

Secondary Outcomes (12)

  • Back pain-related disability (RMDQ)

    baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up

  • Global perceived effect score

    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

    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

    baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up

  • Insomnia measured using the Insomnia Severity Index

    baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up

  • +7 more secondary outcomes

Other Outcomes (2)

  • Activity patterns measured using a GENEActiv activity tracker

    7 days during treatment period

  • Sleep reports measured using a GENEActiv activity tracker

    7 days during treatment period

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Melatonin

EXPERIMENTAL

10mg of melatonin daily for a period of 6 weeks

Drug: Melatonin 10 mg

Interventions

Melatonin 10 mgDRUG

10 mg melatonin daily for a period of 6 weeks

Melatonin
PlaceboDRUG

Daily placebo for a period of 6 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Prof. dr. B.W. (Bart) Koes

CONTACT

010-7035882b.koes@erasmusmc.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

January 31, 2025

First Posted

March 5, 2025

Study Start

April 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 22, 2025

Record last verified: 2025-03

Locations

NL(1)