Melatonin for Patients With Chronic Low Back Pain
Recruiting
Phase 3
Interventional Study
Chronic Low-back Pain (cLBP)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Bart Koes · Other
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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 o…
Trial Locations
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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 intensit…
Contacts