title: Efficacy of the McKenzie method in patients with chronic nonspecific low back pain: a protocol of randomized placebo-controlled trial.
abstract: BACKGROUND
  The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain. Although the McKenzie method has been compared with several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic low back pain.
  
  
  OBJECTIVE
  The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain.
  
  
  METHODS
  An assessor-blinded, 2-arm, randomized placebo-controlled trial will be conducted.
  
  
  METHODS
  This study will be conducted in physical therapy clinics in São Paulo, Brazil.
  
  
  METHODS
  The participants will be 148 patients seeking care for chronic nonspecific low back pain.
  
  
  METHODS
  Participants will be randomly allocated to 1 of 2 treatment groups: (1) McKenzie method or (2) placebo therapy (detuned ultrasound and shortwave therapy). Each group will receive 10 sessions of 30 minutes each (2 sessions per week over 5 weeks).
  
  
  METHODS
  The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The primary outcomes will be pain intensity (measured with the Pain Numerical Rating Scale) and disability (measured with the Roland-Morris Disability Questionnaire) at the completion of treatment. The secondary outcomes will be pain intensity; disability and function; kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization; and kinesiophobia and global perceived effect at completion of treatment. The data will be collected by a blinded assessor.
  
  
  CONCLUSIONS
  Therapists will not be blinded.
  
  
  CONCLUSIONS
  This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain. The results of this study will contribute to better management of this population.
authors.affiliation: A.N. Garcia, PT, PhD Candidate, Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.
authors.forename: Alessandra Narciso
authors.initials: AN
authors.lastname: Garcia
authors.affiliation: L.C.M. Costa, PT, PhD, Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo.
authors.forename: Lucíola da Cunha Menezes
authors.initials: Lda C
authors.lastname: Costa
authors.affiliation: M.J. Hancock, PT, PhD, Discipline of Physiotherapy, Faculty of Human Sciences, Macquarie University, Sydney, New South Wales, Australia.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Hancock
authors.affiliation: M.O. de Almeida, PT, PhD Candidate, Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo.
authors.forename: Matheus Oliveira
authors.initials: MO
authors.lastname: de Almeida
authors.affiliation: F.S. de Souza, PT, Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo.
authors.forename: Fabrício Soares
authors.initials: FS
authors.lastname: de Souza
authors.affiliation: L.O.P. Costa, PT, PhD, Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, and Musculoskeletal Division, The George Institute for Global Health, Sydney, New South Wales, Australia. Mailing address: Rua Cesário Galeno 448, Postcode 03071-100, Tatuapé, São Paulo, Brazil. lcos3060@gmail.com.
authors.forename: Leonardo Oliveira Pena
authors.initials: LO
authors.lastname: Costa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001938:Brazil; D059350:Chronic Pain / Q000534:rehabilitation; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000534:rehabilitation*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D026741:Physical Therapy Modalities; D010919:Placebos; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D010919:Placebos