Effectiveness of Oral Magnesium Supplementation in Fibromyalgia Patients Not Responding to Standard Treatment

Effectiveness of Oral Magnesium Supplementation in Fibromyalgia Patients Not Responding to Standard Treatment: A Randomized Clinical Trial Using Revised Fibromyalgia Impact Questionnaire

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.

Inclusion Criteria:

1. Patients diagnosed with FM according to the American College of Rheumatology (ACR) 2016 criteria
2. Age: 18-65 years.
3. Not responding to conventional treatment (e.g., amitriptyline, duloxetine, pregabalin) for at least 8 weeks
4. Patients giving informed consent for enrollment in the study.

Exclusion Criteria:

• 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