Effects of Modified Intravascular Laser Irradiation of Blood in adults with Fibromyalgia: a randomized placebo-controlled clinical trial

niversidade Federal do Paraná0 个研究点开始时间: 2022年10月20日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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.

•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)

发起方

niversidade Federal do Paraná