Fibromyalgia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria will be considered: women living in the Florianópolis and in the cities of Capão Bonito-SP, São Paulo-SP, Pinhão-PR and Guarapuava-PR aged 18 to 80 years, with the clinical diagnosis of FM. In addition, after the inclusion will have to have the signature of the Term of Consent Free and Informed (ICLE).
Exclusion criteria
Exclusion criteria: The exclusion criteria adopted will be: patients with immunodepressive agents; oncological; infectious diseases; cardiovascular, renal, hepatic, gastrointestinal or psychiatric disorders, use of anti-inflammatory drugs or drugs that affect the inflammatory process (before and after a week of collection of blood), pregnant or lactating, degenerative changes in the spine, herniated discs with motor deficit, post-surgical spine or rheumatic diseases, will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome 1: Assessment of one-dimensional pain scores Method: The pain will be evaluated by Visual Analogue Scale (EVA). EVA consists of a horizontal line with a length of 10 centimeters, numbered 0 to 10, marked "NO PAIN" at one end and the other marked "MAXIMUM PAIN". Patients will make a mark with a dash at the point that represents the intensity of his pain. Collection period: the collection will be done before and after the two sessions, as well as every 15 days and after 60 days will be held segment every 60 days, until completing 3 months.;Outcome 2: Evaluation of multidimensional pain scores Method: The McGill Pain questionnaire will be applied, which evaluates the pain qualitatively and quantitatively. IS divided into four categories (sensory, affective, evaluative and mixed) and 20 subcategories for them. In these words are presented with a number qualifying and quantifying the pain. In the present study, used the sensorial and affective categories, being the highest score in the sensory 32 and affective is 14; the higher the score, the more intense the pain. Collection period: the collection will be done before and after the two sessions, as well as every 15 days and after 60 days will be held segment every 60 days, until completing 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome 3: quality of life assessment Method: to evaluate the quality of life will be applied 4 questionnaires / scales, such as: a) Questionnaire to evaluate the impact of fibromyalgia (FIQ): To evaluate the patients' quality of life, the FIQ questionnaire assessing the impact of fibromyalgia and the quality of patient's life, having questions about functional capacity, difficulties professionals, pain distributed in ten questions, with scales varying from zero to ten, where the higher the score the worse the prognosis. b) SF-36 questionnaire: is a questionnaire is generic in the evaluation of quality of life, since it consists of 36 items related to eight categories, such as such as: functional capacity (10 items), physical aspects (4 items), social aspects (2 items), emotional aspects (3 items), mental health (5 items) and a question of comparison between current and past health conditions. The score is zero to 100, and the lower the score the worse the prognosis. c) Hospital scale of anxiety and depression: seeks to evaluate aspects and anxiety associated with a score of 0 to 21, where the higher the The higher the score will be the limitations related to depression or anxiety. THE interpretation still indicates that scores of 8 to 11 indicate potential for anxiety or depressive disorder; score from 11 to 21 infers an anxious or depressive disorder present. d) Symptom assessment scale - 90 (SCL-90-R): it is a useful tool for follow-up or outcome of the intervention, since it analyzed aspects such as headache, feeling faint and dizzy, and other sensations that may be common to different pathologies. Collection period: the collection will be performed before and after the two sessions, as well as every 15 days and after the 60 days will be made segment every 60 days, until completing 3 months.;Outcome 4: Evaluation of serum levels of cytokines and neurotrophic factors Method: Individual blood will be collected at the beginning and at | — |
Countries
Brazil
Contacts
Universidade do Sul de Santa Catarina