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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: MelatoninExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

from baseline to end of treatment at 6 weeks

Secondary outcomes

Back pain-related disability (RMDQ)

Back pain-related disability is measured using the Roland Morris Disability Questionnaire (RMDQ). The RMDQ outcome ranges from 0-24, where a higher score means more disability.

Time frame

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

Global perceived effect score

Using Global perceived effect (GPE) questionnaire (7-point scale), where a score of 1 means highly satisfied/ great recovery and a score of 7 means highly dissatisfied / poor recovery.

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

Physical and mental health measured using the PROMIS Global Health questionnaire. A 10 items questionnaire, items are scored from 1-5 where a score of 5 is the best outcome and a score of 1 is the worst outcome.

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

Measured using the EQ-5D-5L (questionnaire). The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS (0-100) records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Time frame

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

Other outcomes

Activity patterns measured using a GENEActiv activity tracker

A GENEActiv activity tracker is worn for a period of 7 days during the 6-week treatment period by a subgroup of 60 participants. This device can measure activity and sleep. This measure is use as an explorative objective and only descriptive statistics of the data will be given. GENEActiv software is used to analyse the data.

Time frame

7 days during treatment period

Sleep reports measured using a GENEActiv activity tracker

A GENEActiv activity tracker is worn for a period of 7 days during the 6-week treatment period by a subgroup of 60 participants. This device can measure activity and sleep. A sleep report is created using the GENEActiv software. This measure is used as an explorative measure, only descriptive statistics are done.

Time frame

7 days during treatment period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bart Koes

Lead sponsor

Erasmus Medical Center

Sponsor institution

Source ClinicalTrials.gov

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