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

ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShaikh Zayed Hospital, Lahore

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Magnesium glycinate

    Dietary supplement

    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.

  • Vitamins

    Dietary supplement

    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.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Standard Fibromyalgia treatment plus Magnesium glycinate supplementExperimental treatment 1 intervention
Group B: Standard FM treatment plus Vitamin supplement as placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Revised 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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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