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Melatonin and Immunonutrition for Pain Relief in Fibromyalgia

ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Thessaly

About this trial

Fibromyalgia (FMS) is characterized by chronic musculoskeletal pain, sleep disturbances, and fatigue. It is not entirely clear how Bcomplex vitamins affect the human pain system, while at the same time there have been approaches that use melatonin in patients with FMS and report improvements in pain and sleep quality.

The purpose of this study is to investigate the efficacy of a combined immunonutrition and melatonin intervention in patients with FMS through a randomized clinical trial (RCT). The combined effect of immunonutrition and melatonin, administered intravenously once a week and orally respectively, versus placebo, will be examined in patients with FMS, for a period of 5 weeks. The primary endpoints concern the quantification of pain and quality of life, while the secondary endpoints are sleep quality, fatigue and inflammatory markers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin 1mg and intravenous B-complex vitamin drip

    Dietary supplement

    Patients will receive Melatonin 1mg half an hour before sleep every day and intravenous B-complex vitamin drip every week for a total of five weeks

  • Placebo

    Dietary supplement

    Per os corn startch placebo capsules every night half an hour before sleep and intravenous N/S 500mL drip every week

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ImmunonutritionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

VAS pain

Pain on a scale from 0 to 10 where 0 indicates "no pain" and 10 indicates "the worst possible pain"

Time frame
5 weeks
2

Brief Pain Inventory (BPI)

Time frame
5 weeks
3

Revised Fibromyalgia Impact Questionnaire (FIQR)

Time frame
5 weeks
4

Functional Assessment of Chronic Illness Therapy (FACIT)

Time frame
5 weeks

Secondary outcomes

1

Epworth Sleepiness Scale (ESS)

Time frame
5 weeks
2

Fatigue Severity Scale (FSS)

Time frame
5 weeks
3

Inflammatory markers

CRP, ESR

Time frame
5 weeks
4

Beck Depression Inventory (BDI)

Time frame
5 weeks

Other outcomes

Sponsors and contacts

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

University of Thessaly

Lead sponsor

Source ClinicalTrials.gov
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