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

8. maj 2026 opdateret af: Masooma Hashmat, Shaikh Zayed Hospital, Lahore

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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

86

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 45000
        • Rekruttering
        • Shaikh Zayed Hospital, Lahore
        • Kontakt:
        • Kontakt:
          • Ayesha Humayun, FCPS, PhD
          • Telefonnummer: +923214343065
          • E-mail: ayeshah@gmil.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Standard Fibromyalgia treatment plus Magnesium glycinate supplement

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 magnesium glycinate 850 mg once daily at night for 24 weeks.

- 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 FIQ, WPI/SSS, and record adverse events; serum magnesium and renal panels will be re measured at week 12 and 24.
Kosttilskud: Magnesium glycinate
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.
Placebo komparator: Standard FM treatment plus Vitamin supplement as placebo

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 vitamin supplement as placebo once daily at night for 24 weeks.

- 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 FIQ, WPI/SSS, and record adverse events; serum magnesium and renal panels will be re measured at week 12 and 24.
Kosttilskud: Vitamins
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Revised Fibromyalgia Impact Questionnaire (FIQR)
Tidsramme: 24 weeks
Changes in FIQR total score higher scores >59 means severe disease and low scores<39 means remission
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in FIQR subdomains
Tidsramme: 24 weeks
changes in individual FIQ sub domains (function, overall impact and symptoms) low score means improvement high scores severe disease
24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shaikh Zayed Hospital, Lahore

Efterforskere

  • Ledende efterforsker: Masooma Hashmat, FCPS, Shaikh Zayed Hospital, Lahore
  • Studieleder: Aflak Rasheed, FCPS, Shaikh Zayed Hospital, Lahore
  • Studiestol: Ayesha Humayun, FCPS, PhD, Shaikh Zayed Hospital, Lahore

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. april 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

26. februar 2027

Datoer for studieregistrering

Først indsendt

2. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TERC/SC/INT/2026/36

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

one year

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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