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).
This study is a prospective randomized controlled clinical trial aimed 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). METHODOLOGY Participants who meet ACR 2016 fibromyalgia criteria and have shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics and provided written informed consent. After confirming eligibility, baseline data-including demographics, medication history, serum magnesium and calcium levels, and renal function-will be collected, and each subject will complete the Fibromyalgia Impact Questionnaire Revised (FIQR). Using a computer generated block randomization, participants will be assigned to receive either oral magnesium glycinate 850 mg once daily at night or a placebo (vitamin supplement) daily for 24 weeks. FOLLOW-UP Throughout the study, 4 weekly follow-ups will be advised to monitor adherence, side effects, and any changes in concurrent medications, while pill counts and patient diaries will be used to verify compliance. On 4 weekly follow up visits will repeat the FIQR, record adverse events; serum magnesium and renal panels will be re measured at week 12 and 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Fibromyalgia 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.
Fibromyalgia 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.
Shaikh Zayed Hospital, Lahore
Lahore, Punjab Province, Pakistan
RECRUITINGRevised Fibromyalgia Impact Questionnaire (FIQR)
Changes in FIQR total score higher scores \>59 means severe disease and low scores\<39 means remission
Time frame: 24 weeks
Changes in FIQR subdomains
changes in individual FIQ sub domains (function, overall impact and symptoms) low score means improvement high scores severe disease
Time frame: 24 weeks
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