title: Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial).
abstract: The stratified model of care has been an effective approach for the treatment of low back pain. However, the treatment of patients with low risk of psychosocial-factor involvement is unclear. The addition of the therapeutic alliance to a minimal intervention may be an option for the treatment of low back pain. This paper reports on the rationale, design and protocol for a randomized controlled trial with blind assessor to assess the effectiveness of the addition of therapeutic alliance with minimal intervention on pain and disability in patients with chronic, nonspecific low back pain.
  
  
  
  Two hundred and twenty-two patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors will be assessed and randomly allocated into three groups (n = 74 patients per group). The Positive Therapeutic Alliance group will receive counseling and guidance with an emphasis on therapeutic alliance and empathy. The Usual Treatment group will receive the same information and counseling with limited interaction with the therapist. The Control group will not receive any intervention. The treatment will be composed by two intervention sessions with a 1-week interval. A blinded assessor will collect the following outcomes at baseline, 1 month, 6 months and 12 months after randomization: pain intensity (Pain Numerical Rating Scale), specific disability (Patient-specific Functional Scale), general disability (Oswestry Disability Index), global perceived effect (Global Perceived Effect Scale), empathy (Consultation and Relational Empathy Measure), credibility and expectations related to treatment. The analysis will be performed using linear mixed models.
  
  
  
  This will be the first study to understand the effect of combining enhanced therapeutic alliance to a treatment based on counseling, information and advice (minimal intervention). The addition of the therapeutic alliance to minimal intervention may improve the treatment of chronic, nonspecific low back pain.
  
  
  
  ClinicalTrials.gov, NCT 02497625. Registered on 10 July 2015.
authors.affiliation: Master's and Doctoral Programs in Physical Therapy of the Universidade Cidade de Sao Paulo, Rua Cesário Galeno 475, Tatuapé, São Paulo, SP, CEP: 03071-000, Brazil. felipercfagundes@gmail.com.
authors.forename: Felipe Ribeiro Cabral
authors.initials: FR
authors.lastname: Fagundes
authors.affiliation: Physical Therapy Department of the Universidade de Taubaté, Av. Marechal Arthur Costa e Silva 1055, Centro, Taubaté, SP, Brazil.
authors.forename: Caique
authors.initials: C
authors.lastname: de Melo do Espírito Santo
authors.affiliation: Master's and Doctoral Programs in Physical Therapy of the Universidade Cidade de Sao Paulo, Rua Cesário Galeno 475, Tatuapé, São Paulo, SP, CEP: 03071-000, Brazil.
authors.forename: Francine Mendonça
authors.initials: FM
authors.lastname: de Luna Teixeira
authors.affiliation: Physical Therapy Department of the Universidade de Taubaté, Av. Marechal Arthur Costa e Silva 1055, Centro, Taubaté, SP, Brazil.
authors.forename: Thaís Vanelli
authors.initials: TV
authors.lastname: Tonini
authors.affiliation: Master's and Doctoral Programs in Physical Therapy of the Universidade Cidade de Sao Paulo, Rua Cesário Galeno 475, Tatuapé, São Paulo, SP, CEP: 03071-000, Brazil.
authors.forename: Cristina Maria Nunes
authors.initials: CM
authors.lastname: Cabral
mesh_terms: D001938:Brazil; D059350:Chronic Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D004185:Disability Evaluation; D004645:Empathy; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010147:Pain Measurement; D010353:Patient Education as Topic; D010817:Physician-Patient Relations; D011613:Psychotherapy / Q000379:methods*; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
keywords: Empathy; Low back pain; Minimal intervention; Subgroups