Avaliação dos efeitos do dispositivo MR5® Lasershower no alívio temporário da dor em pacientes com fibromialgia: ensaio clínico randomizado, placebo controlado e triplo-cego

Abstract

INTRODUCTION: Fibromyalgia is a syndrome defined by the American College of Rheumatology (ACR) as a diffuse pain in at least 11 of 18 specific tender points. It is related to deficiency in pain regulation and to symptoms such as fatigue, sleep disturbance and cognitive alterations, which negatively interfere in the patients' quality of life. Studies suggest that the combination of Photobiomodulation Therapy (PBMT) and static Magnetic Field (sMF) seems to have a positive interaction in decreasing the intensity of musculoskeletal pain in patients with fibromyalgia. However, more studies need to be carried out in order to establish a pattern of use of PBMT/sMF for the management of fibromyalgia. OBJECTIVE: Investigate the effectiveness of MR5® LaserShower in temporary pain relief in patients with fibromyalgia. METHODS: A randomized, placebo-controlled and triple-blind clinical trial was carried out, with the voluntary participation of 90 female patients diagnosed with fibromyalgia, divided into two groups (n=45) who underwent PBMT/sMF with the device MR5® LaserShower, active and placebo, on alternate days, 3 times a week, for 3 weeks. The following parameters were analyzed, the Generalized Pain Index (GPI), the Fibromyalgia Impact Questionnaire (FIQ), the Visual Analog Scale (VAS) and the Satisfaction Scale (LIKERT). The tests were applied before and after the treatment protocol, and 30 days after the last treatment. RESULTS: The PBMT/sMF active group showed a decrease in the GPI in the last treatment and 30 days after (p <0.0001) in relation to the placebo. There was also a decrease in the number of total FIQ scores in the active PBMT/sMF group compared to the placebo group in the last treatment (p <0.001) and 30 days after (p <0.05). VAS demonstrated a decrease in pain intensity in the PBMT/sMF active group compared to placebo in the last treatment (p <0.0001) and 30 days after (p <0.001). The evaluation of the patients' contentment (LIKERT) with the result of the treatment showed that the majority of the patients in the active PBMT/sMF group were satisfied in the two evaluated moments. CONCLUSION: The treatment of PBMT/sMF with the MR5® LaserShower device is effective in reducing the number of tender points and the intensity of the pain, also providing the reduction of symptoms and improving the quality of life of patients with fibromyalgia.