Fibromyalgia
Conditions
Brief summary
The onset of chronic Fibromyalgia symptomatology is due to central alterations, together with peripheral neuroimmune modifications. Using positron emission tomography (PET), it has been observed for the first time that fibromyalgia patients have a high activation of microglial cells compared to normal subjects. Experimental evidence in neuroinflammation models in vitro and in vivo have demonstrated the anti-inflammatory and neuroprotective effect of Palmitoylethanolamide (PEA), effects confirmed by observational clinical investigations conducted in patients with fibromyalgia in which micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA) reduced the intensity of pain improving the quality of life. The aim of this study is to investigate the efficacy and tolerability of PEA-m + PEA-um administered as an add-on therapy with a double-blind, randomized, placebo-controlled clinical investigation.
Interventions
DIETARY_SUPPLEMENTmicronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
OTHERPlacebo microgranules 1800mg
Placebo was prepared to be indistinguishable from color and flavor from the Product
DRUGStandard Therapy
(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months
DRUGRescue Drug
Use as needed allowed
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Epitech Group SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology 2016 (symptoms for at least 3 months, Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI 4-6 and SS ≥ 9) * Pain intensity assessed on the Visual Analogue Scale (VAS) ≥ 40 * PEA-naive patients * Patients who agree to sign informed consent
Exclusion criteria
* Values of WPI \<7 and SS \<5 * Pain intensity assessed on the Visual Analogue Scale (VAS) \<40 * Patients who have already taken PEA in the past * Allergic or hypersensitive subjects to the product and / or one or more of its excipients * Patients who refuse to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised | 90 days | Change of Fibromyalgia symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health assessed by Short form-12 Health Survey | 90 days | Change in Health at the end of treatment |
| Sleep Disorders assessed by Pittsburgh Sleep Quality Index | 90 days | Change in sleep disorders at the end of treatment |
| Pain Intensity assessed by Visual Analogue Scale | 90 days | Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain) |
| Incidence of Adverse Events | 90 days | Monitoring of adverse event |
| Blood test | 90 days | Clinically significant changes in blood test |
| Rescue Drugs consumption assessed by a daily diary | 90 days | Change in rescue drugs consumption during the entire period |
Countries
Italy
Outcome results
None listed