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NCT Number: NCT07585045

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

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).

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

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.

Primary outcomes

  1. Revised Fibromyalgia Impact Questionnaire (FIQR)

    Time frame: 24 weeks

    Changes in FIQR total score higher scores >59 means severe disease and low scores<39 means remission

Secondary outcomes

  1. Changes in FIQR subdomains

    Time frame: 24 weeks

    changes in individual FIQ sub domains (function, overall impact and symptoms) low score means improvement high scores severe disease

Study contacts

Contact information is provided by the study sponsor or research team.

Ayesha Humayun, FCPS, PhD

CONTACT

[email protected]

+923214343065

Masooma Hashmat, FCPS

CONTACT

[email protected]

+923353053304

Sponsors and collaborators

Lead sponsor

Shaikh Zayed Hospital, Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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