Effects of photobiomodulation with progressive dosing associated with an aerobic exercise protocol on the level of pain and quality of life of women with fibromyalgia: controlled, randomized and blind

Abstract

Fibromyalgia (FM) is characterized by chronic generalized muscle pain, which affects mainly women. Several studies have already shown that aerobic exercises are effective in improving the pain and quality of life of this population; other studies that photobiomodulation (FBM) is also effective in this regard. However, there is no consensus in the literature regarding the best parameters of FBM to treat patients with FM, as well as in progressive dosage throughout treatment. Thus, the objective of this study will be to verify the effect of the association of an aerobic exercise protocol and FBM, with progressive dosage, on the level of pain and the health-related quality of life of women with FM. The women will be randomized and divided into two groups: GEFA: exercise group and active FBM (n = 15), or GEFP: exercise group and placebo FBM (n = 15). Before the first session and after the last treatment session, the level of pain will be assessed as the primary outcome using the Visual Analogue Scale (VAS), and as secondary outcomes the Impact of Fibromyalgia on quality of life, quality of life by SF-36, Fatigue level by FSS, physical activity level by IPAQ, Timed Up-and-Go Test (TUG) and functional capacity by the 6-minute Walk Test (6MWT). The interventions will last for 12 weeks, twice a week with the performance of aerobic exercise on a stationary bicycle and progression of load through the maximum heart rate obtained by the cardiorespiratory test. This work will be submitted to the Brazilian Registry of Clinical Trials (ReBEC). The data of both the primary and secondary outcomes will be presented in the form of mean and standard deviation and submitted to parametric statistics, analysis of variance (ANOVA), to compare groups and treatment effect.