Fibromyalgia
Conditions
Interventions
The intervention will be done by audiovisual neurostimulation with the Braintap device (headphone and light-emitting glasses). The control group (n = 61) will undergo the same procedures with the devi
E01.370.376.300.150
Sponsors
Universidade do Sul de Santa Catarina
Universidade do Sul de Santa Catarina
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women with a clinical diagnosis of FM; living in the greater Florianópolis SC; aged between 18 and 80 years and undergoing pharmacological treatment.
Exclusion criteria
Exclusion criteria: Women with diseases that can be stimulated by light; with immunodepressive diseases; with oncological diseases; with infectious diseases or in a febrile state, epileptics; pregnant women; lactating women; women with symptoms or confirmation of COVID-19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain will be assessed by EVA. The EVA consists of a horizontal line with 10 centimeters in length numbered from 0 to 10, marked at one end with the classification "WITHOUT PAIN" and at the other with the classification "MAXIMUM PAIN". Patients will mark with a dash at the point that represents the intensity of their pain. Pain will also be assessed using the McGill questionnaire, which qualitatively and quantitatively evaluates pain. It is arranged in four categories (sensory, affective, evaluative and mixed) and 20 subcategories for them. In these words are presented with a corresponding number, qualifying and quantifying the pain. The collection will be made on the first day, after fifteen days, after thirty days, after 45 days and after 60 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of serum measurements of cytokines, neurotrophic factors and melatonin. Method: Blood samples will be taken at the beginning and at the end of the intervention to measure the concentration of serum neurotrophic factors and cytokines, by PPGCS professors and / or pharmacists collaborating on the project. The blood collection site will be the skills laboratory of UNISUL-PB. Blood samples for measurement of melatonin and inflammatory cytokine concentrations will be collected by a nurse at HU-UFSC. The blood collection site will be the UNISUR skills laboratory. The collections will be carried out in two moments (pre and post-intervention) in the skills laboratory of UNISUL between 7 am and 9 am with the participants fasting for 12 hours. 10 ml of blood will be taken from the cubital vein of each participant. The participants' peripheral blood will be collected in 10 ml syringes (brand SR lot: 420 I) and needle 0.80 x 25mm (Brand SR Lot 5292198) and placed in 2.0 ml transparent microtubes - K30-1020. The samples will be processed at LaNEx, where the blood will be centrifuged at 5000 rpm, for 5 minutes and the serum removed in a sterile environment, will be stored in microcentrifuge tubes and kept in a freezer at -80ºC for further processing. The analyzes of TNF, IL-1ß, IL-10, IL-6, IL-8 and melatonin will be performed by the ELISA method (enzyme-linked immunosorbent assay) using the DuoSet ELISA kit (R&D Systems, Minnesota, MN, USA) for humans. The readings will be performed by a microplate reader set to 490 nanometers and correction (subtracting) of the wavelength read at 650 nm. Values will be expressed in pg / ml. The samples will be analyzed for the cytokines described in the project, right after the collections, both in the pre and post, and future measurements will not be performed. Collection period: the collection will be carried out before and after the end of the interventions. ;Heart rate variability The activity of the autonomic nervous sys | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Outcome results
None listed