Fibromyalgia
Conditions
Keywords
Fibromyalgia, Magnesium supplement, Revised Fibromyalgia Impact Questionnaire
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMagnesium 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.
DIETARY_SUPPLEMENTVitamins
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.
Sponsors
Shaikh Zayed Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Fibromyalgia patients who shown no improvement after at least two months of single standard therapy (amitriptyline, duloxetine, pregabalin) will be recruited from rheumatology clinics. 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 or a placebo (vitamin supplement) once daily at night for 24 weeks. 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, serum magnesium and renal panels will be measured.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQR) | 24 weeks | Changes in FIQR total score higher scores \>59 means severe disease and low scores\<39 means remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in FIQR subdomains | 24 weeks | changes in individual FIQ sub domains (function, overall impact and symptoms) low score means improvement high scores severe disease |
Countries
Pakistan
Contacts
CONTACTMasooma Hashmat, FCPS
CONTACTAyesha Humayun, FCPS, PhD
PRINCIPAL_INVESTIGATORMasooma Hashmat, FCPS
Shaikh Zayed Hospital, Lahore
STUDY_CHAIRAyesha Humayun, FCPS, PhD
Shaikh Zayed Hospital, Lahore
STUDY_DIRECTORAflak Rasheed, FCPS
Shaikh Zayed Hospital, Lahore
Outcome results
None listed