Fibromyalgia
Conditions
Interventions
INTERVENTION GROUP (TREATMENT):
a) Intervention: In each session a protocol of transcranial photobiomodulation (FBMt) will be applied through a device called NeuroLux whose internal space is composed
Sponsors
None listed
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women diagnosed with Fibromyalgia; residing in the Greater Florianópolis-SC; aged from 18 years; who are undergoing pharmacological treatment for Fibromyalgia.
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 and/or confirmation of COVID-19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome 1: Pain Assessment Visual Analogue Scale (VAS) will be the tool used to assess pain intensity. This scale consists of a horizontal line of 10 centimeters with a number from 0 to 10, where the minimum corresponds to “no pain” and the maximum “maximum pain”. Women will mark a line at the point that represents the intensity of their pain. Collection period: the collection will be carried out before and after all interventions days, as well as 3 and 6 months after the end of the protocol as well. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome 2: quality of life assessment To assess the quality of life, 6 questionnaires / scales will be applied, whose collections will be before the beginning of the protocol and at the end (day 0 and day 56), as well as 3 and 6 months after the last application. They will be: a) Revised Fibromyalgia Impact Questionnaire (FM) for Brazil (FIQR - Br). The questionnaire consists of twenty-one items divided into three groups. All questions have a numerical scale from 0 - 10, with 10 being the “most severe”. The first group consists of nine questions related to function, and the total score is given by the sum of the questions divided by three (0 - 30). The second group refers to the general impact and has two questions, with a score from 0 to 20. The last group consists of ten items related to the symptoms and their intensity, the score is the result of the sum of all divided by two (0 - 50 ). b) Short Form Health Survey 36 (SF - 36): the standardized Short Form Health Survey 36 (SF-36) questionnaire will be applied to assess the health status and the impact of the syndrome on women's daily quality of life. It is a multidimensional questionnaire that consists of 36 items subdivided into eight scales: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects and mental health. The final score is from zero to one hundred, where zero is the worst prognosis. c) Sleep quality: women's sleep quality will be assessed using the Pittsburgh Quality of Sleep Index (PSQI-BR) tool. The instrument consists of eighteen questions and each can score from 0 to 3. The overall score results from the sum of all and can vary from 0 to 18. The higher the score, the worse the quality of sleep. Scores> 5 are considered an indicator of poor sleep quality. The purpose of the tool is to assess sleep quality by the global score and by the domains: subjective quality; latency; duration; habitual efficiency; disorders; use of sleeping medications; d | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Outcome results
None listed