title: Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin.
  
  
  METHODS
  A randomized controlled clinical trial will be conducted. It will involve 60 women ≥ 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay.
  
  
  CONCLUSIONS
  This is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. fisioterapeutamariana@gmail.com.
authors.forename: Mariana Moreira
authors.initials: MM
authors.lastname: da Silva
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. regianeequilibrare@yahoo.com.br.
authors.forename: Regiane
authors.initials: R
authors.lastname: Albertini
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. ernesto.leal.junior@gmail.com.
authors.forename: Ernesto Cesar Pinto
authors.initials: EC
authors.lastname: Leal-Junior
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. paulo.tarso@uninove.br.
authors.forename: Paulo
authors.initials: P
authors.lastname: de Tarso Camillo de Carvalho
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. josejr@uninove.br.
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Silva
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. sandra.skb@gmail.com.
authors.forename: Sandra Kalil
authors.initials: SK
authors.lastname: Bussadori
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. oliveira.lvf@uninove.br.
authors.forename: Luis Vicente Franco
authors.initials: LV
authors.lastname: de Oliveira
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. cezarcasarin@uninove.br.
authors.forename: Cezar Augusto Souza
authors.initials: CA
authors.lastname: Casarin
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. erinaldo_andrade@uol.com.br.
authors.forename: Erinaldo Luiz
authors.initials: EL
authors.lastname: Andrade
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. bocaliniht@hotmail.com.
authors.forename: Danilo Sales
authors.initials: DS
authors.lastname: Bocalini
authors.affiliation: Nove de Julho University, Rua Vergueiro, 235, Liberdade, São Paulo, SP, 01504-000, Brazil. andreyserra@gmail.com.
authors.forename: Andrey Jorge
authors.initials: AJ
authors.lastname: Serra
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000378:metabolism; D001938:Brazil; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004867:Equipment Design; D005081:Exercise Therapy / Q000009:adverse effects; D005260:Female; D005356:Fibromyalgia / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D054023:Lasers, Semiconductor; D028022:Low-Level Light Therapy / Q000009:adverse effects / Q000295:instrumentation; D010147:Pain Measurement; D011788:Quality of Life; D012107:Research Design; D012463:Saliva / Q000378:metabolism; D012701:Serotonin / Q000378:metabolism; D011795:Surveys and Questionnaires; D013705:Temporomandibular Joint Disorders / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D012701:Serotonin