title: Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial.
abstract: BACKGROUND
  Low-level laser therapy (LLLT) has been widely used as adjuvant strategy for treatment of musculoskeletal disorders. The light-tissue interaction (photobiostimulation) promotes analgesic and anti-inflammatory effects and improves tissue healing, which could justify the recommendation of this therapy for patients with fibromyalgia, leading to an improvement in pain and possibly minimizing social impact related to this disease. The present study proposes to evaluate the effect of LLLT on tender points in patients with fibromyalgia, correlating this outcome with quality of life and sleep.
  
  
  METHODS
  One hundred and twenty patients with fibromyalgia will be treated at the Integrated Health Center and the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University located in the city of Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied. The 120 volunteers will be randomly allocated to an intervention group (LLLT, n = 60) or control group (CLLLT, n = 60). Patients from both groups will be treated three times per week for four weeks, totaling twelve sessions. However, only the LLLT group will receive an energy dose of 6 J per tender point. A standardized 50-minute exercise program will be performed after the laser application. The patients will be evaluated regarding the primary outcome (pain) using the following instruments: visual analog scale, McGill Pain Questionnaire and pressure algometry. The secondary outcome (quality of life and sleep) will be assessed with the following instruments: Medical Outcomes Study 36-item Short-Form Health Survey, Fibromyalgia Impact Questionnaire, Berlin Questionnaire, Epworth Sleepiness Scale and polysomnography. ANOVA test with repeated measurements for the time factor will be performed to test between-groups differences (followed by the Tukey-Kramer post hoc test), and a paired t test will be performed to test within-group differences. The level of significance for the statistical analysis will be set at 5% (P ≤ .05).
  
  
  BACKGROUND
  The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-42gkzt).
authors.affiliation: Post Graduate Program in Rehabilitation Sciences, Nove de Julho University UNINOVE, Rua Vergueiro, 235, São Paulo, SP, 01504-001, Brazil. paulo.tarso@uninove.br
authors.forename: Paulo de Tarso Camillo
authors.initials: Pde T
authors.lastname: de Carvalho
authors.forename: Ernesto Cesar Pinto
authors.initials: EC
authors.lastname: Leal-Junior
authors.forename: Ana Carolina Araruna
authors.initials: AC
authors.lastname: Alves
authors.forename: Caroline Sobral de Melo
authors.initials: CS
authors.lastname: Rambo
authors.forename: Luciana Maria Malosa
authors.initials: LM
authors.lastname: Sampaio
authors.forename: Claudia Santos
authors.initials: CS
authors.lastname: Oliveira
authors.forename: Regiane
authors.initials: R
authors.lastname: Albertini
authors.forename: Luis Vicente Franco
authors.initials: LV
authors.lastname: de Oliveira
mesh_terms: D001938:Brazil; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005081:Exercise Therapy; D005356:Fibromyalgia / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000532:radiotherapy*; D006801:Humans; D028022:Low-Level Light Therapy; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000523:psychology / Q000532:radiotherapy*; D010147:Pain Measurement; D017288:Pain Threshold; D017286:Polysomnography; D011788:Quality of Life; D012107:Research Design; D012890:Sleep; D012893:Sleep Wake Disorders / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000523:psychology / Q000532:radiotherapy*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome