Fibromyalgia
Conditions
Interventions
This is a randomized, placebo-controlled, single-blind clinical trial. Sixty (60) women with fibromyalgia (18 to 60 years) will be evaluated, randomly divided into an experimental and placebo group.
E02 594 540
E02 774
I02 233 332
Sponsors
Universidade Federal do Paraná
Universidade Federal do Paraná
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The study will include: women with age ranging from 18 to 60 years (the age limit is set to minimize structural changes due to aging), diagnosed with fibromyalgia according to the diagnostic criteria which was set in the 2016 modification of the American College of Rheumatology (WOLFE et al. ., 2016). In general, the participants must have generalized pain in at least 4 of 5 body regions for at least 3 months, with a score of 7 on the Widespread Pain Index (WPI) questionnaire and 5 on the Severity Scale /Symptom Severity Scale (SSS), or WPI between 4 to 6 and SSS = 9. In that last case, the fibromyalgia symptom scale (FS- Fibromyalgia Severity) is added, which is defined as the sum of the previous two questionnaires as a complete component of the diagnostic criteria, as presented in ANNEX I. According to UFPR‘s Normative Instruction No. 01/2021 (PRPPG/PROGRAD/PROEC), only participants who present a complete vaccination schedule or the ones who present negative results for SARS-CoV-2.0 infection in periodic examination reports of RT-qPCR or antigen type at every 72 hours will be allowed to be included in this study.
Exclusion criteria
Exclusion criteria: Women with cognitive deficits determined by achieving less than 13 points in the Mini-Mental State Examination will be excluded of this study (ANNEX 2) (SANTOS et al., 2010); hearing loss which prevents the understanding of verbal instructions; neurological disorders and/or trauma-orthopedic conditions that prevent the participant from carrying out the assessments and/or the proposed intervention; pregnant or lactating women; having an acute or terminal illness; presence of other pathologies at the application site; women who are undergoing physiotherapeutic treatment concomitant to the study; women who make use of steroids which which interfere with the action of ILIB; women who have modified their pharmacological treatment during the study or month prior to the intervention; women who have not taken at least the first dose of the Covid-19 vaccine; and any contraindication for the application of ILIB, namely: cardiogenic shock, arterial hypotension, heart disease, stages II and III of circulatory failure, anemia, sick sinus syndrome, existence of blood coagulopathies (MIKHAILOV, 2009)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will observe a decrease in pain, verified by the Visual Analogue Scale (VAS) and Algometry, from a variation of at least 5% in pre- and post-intervention measurements.;We will verify a decrease in the severity of fibromyalgia symptoms, verified by the Fibromyalgia Severity Scale, from a variation of at least 5% in pre- and post-intervention measurements.;We will verify a decrease in the impact of fibromyalgia, verified by the Fibromyalgia Impact Questionnaire (FIQ-R), from a variation of at least 5% in pre- and post-intervention measurements. ;We will verify an improvement in knowledge about fibromyalgia and greater self-care capacity, verified through Revised Appraisal of Self-care Agency Scale (ASAS-R), from a variation of at least 5% in measurements pre and post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will verify a decrease in fatigue, verified in the Fatigue Severity Scale (FSS), from a variation of at least 5% in pre- and post-intervention measurements.;We will verify a decrease in depression, verified by the Beck Depression Inventory (BDI), from a variation of at least 5% in pre- and post-intervention measurements.;We will verify a decrease in anxiety, verified by the Beck Anxiety Inventory (BAI), from a variation of at least 5% in pre- and post-intervention measurements.;We will verify an improvement in sleep quality, verified by the Pittsburgh Sleep Quality Index (PSQI-BR), from a variation of at least 5% in pre- and post-intervention measurements.;We will verify an improvement in quality of life, verified by the WHOQOL-BREF questionnaire, based on a variation of at least 5% in pre- and post-intervention measurements.;We will verify better satisfaction with the resource in the intervention group, verified by the resource application satisfaction questionnaire, based on a variation of at least 5% in pre- and post-intervention measurements. | — |
Countries
Brazil
Contacts
Public ContactRaciele Korelo
Universidade Federal do Paraná
Outcome results
None listed