fibromyalgia
Conditions
Interventions
The study will include two parallel groups, randomly allocated and double-blinded. The intervention group will consist of 21 participants receiving Amitriptyline 25 mg combined with elemental Magnesiu
Sponsors
Universidade Federal de São Paulo (UNIFESP)
Universidade Federal de São Paulo (UNIFESP)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over eighteen years; diagnosis of Fibromyalgia obtained using the Fibromyalgia Survey Questionnaire FSQ – Brazil; pain intensity greater than or equal to four.
Exclusion criteria
Exclusion criteria: Other documented or suspected causes of pain; use of illicit drugs; pregnant women; previous or current treatment with dietary supplements containing Magnesium; concurrent inclusion in another interventional study; inability to understand the information provided to participants or to sign the Informed Consent Form; use of medications such as calcitonin, glucagon, potassium-sparing diuretics, fluoroquinolones, aminoglycosides, bisphosphonates, calcium channel blockers, tetracyclines, or muscle relaxants; renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction in pain intensity in patients with fibromyalgia after 12 weeks of treatment with magnesium combined with amitriptyline compared to placebo combined with amitriptyline, verified using the Visual Analog Scale (VAS) for pain, considering a clinical response as a minimum reduction of 30% in the score compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate improvement in quality of life after 12 weeks of treatment, verified using the Fibromyalgia Impact Questionnaire (FIQ), considering a minimum reduction of 14% in the score compared to baseline. To evaluate improvement in sleep quality after 12 weeks, verified using the Pittsburgh Sleep Quality Index (PSQI), considering a minimum reduction of 3 points in the score compared to baseline. To evaluate the occurrence of adverse events during treatment, verified through spontaneous report or clinical observation, considering the frequency and severity of events in each group. | — |
Countries
Brazil
Contacts
Public ContactFelipe Oliveira
Universidade Federal de São Paulo (UNIFESP)
Outcome results
None listed