About this trial
Fibromyalgia is a complex widespread pain disorder. OBJECTIVES To evaluate the effectiveness of oral magnesium supplementation in reducing symptom severity among fibromyalgia patients who have not responded to standard treatment, using validated scoring systems such as the Fibromyalgia Impact Questionnaire Revised (FIQR).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with FM according to the American College of Rheumatology (ACR) 2016 criteria
Age: 18-65 years.
Not responding to conventional treatment (e.g., amitriptyline, duloxetine, pregabalin) for at least 8 weeks
Patients giving informed consent for enrollment in the study.
Disqualifiers
1- Patients with renal impairment 2- Pregnant or lactating women 3- Already on magnesium or other mineral supplements 4- Known cases of inflammatory arthritis or other chronic pain syndromes
Trial design
Parallel
Treatments tested in this trial
Magnesium glycinate
Dietary supplementFibromyalgia patients who have shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics. Half participant randomly will be assigned to receive oral magnesium glycinate 850 mg once daily at night for 24 weeks.
Vitamins
Dietary supplementFibromyalgia patients who have shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics. Half participant will be randomly assigned to receive oral placebo (vitamin supplement) daily for 24 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Revised Fibromyalgia Impact Questionnaire (FIQR)
Changes in FIQR total score higher scores \>59 means severe disease and low scores\<39 means remission
Secondary outcomes
Changes in FIQR subdomains
changes in individual FIQ sub domains (function, overall impact and symptoms) low score means improvement high scores severe disease
Sponsors and contacts
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