title: Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study.
abstract: Components other than the active ingredients of treatment can have substantial effects on pain and disability. Such 'non-specific' components include: the therapeutic relationship, the healthcare environment, incidental treatment characteristics, patients' beliefs and practitioners' beliefs. This study aims to: identify the most powerful non-specific treatment components for low back pain (LBP), compare their effects on patient outcomes across orthodox (physiotherapy) and complementary (osteopathy, acupuncture) therapies, test which theoretically derived mechanistic pathways explain the effects of non-specific components and identify similarities and differences between the therapies on patient-practitioner interactions.
  
  
  
  This research comprises a prospective questionnaire-based cohort study with a nested mixed-methods study. A minimum of 144 practitioners will be recruited from public and private sector settings (48 physiotherapists, 48 osteopaths and 48 acupuncturists). Practitioners are asked to recruit 10-30 patients each, by handing out invitation packs to adult patients presenting with a new episode of LBP. The planned multilevel analysis requires a final sample size of 690 patients to detect correlations between predictors, hypothesised mediators and the primary outcome (self-reported back-related disability on the Roland-Morris Disability Questionnaire). Practitioners and patients complete questionnaires measuring non-specific treatment components, mediators and outcomes at: baseline (time 1: after the first consultation for a new episode of LBP), during treatment (time 2: 2 weeks post-baseline) and short-term outcome (time 3: 3 months post-baseline). A randomly selected subsample of participants in the questionnaire study will be invited to take part in a nested mixed-methods study of patient-practitioner interactions. In the nested study, 63 consultations (21/therapy) will be audio-recorded and analysed quantitatively and qualitatively, to identify communication practices associated with patient outcomes.
  
  
  
  The protocol is approved by the host institution's ethics committee and the NHS Health Research Authority Research Ethics Committee. Results will be disseminated via peer-reviewed journal articles, conferences and a stakeholder workshop.
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: Katherine
authors.initials: K
authors.lastname: Bradbury
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: Miznah
authors.initials: M
authors.lastname: Al-Abbadey
authors.affiliation: Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Dawn
authors.initials: D
authors.lastname: Carnes
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Borislav D
authors.initials: BD
authors.lastname: Dimitrov
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Eardley
authors.affiliation: Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Carol
authors.initials: C
authors.lastname: Fawkes
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Foster
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: Maddy
authors.initials: M
authors.lastname: Greville-Harris
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: J Matthew
authors.initials: JM
authors.lastname: Harvey
authors.affiliation: Clinical Research Centre for Health Professions, University of Brighton, Brighton, UK.
authors.forename: Janine
authors.initials: J
authors.lastname: Leach
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.
authors.forename: George
authors.initials: G
authors.lastname: Lewith
authors.affiliation: Health Sciences, University of York, New York, UK.
authors.forename: Hugh
authors.identifier: 0000-0003-4255-4768
authors.initials: H
authors.lastname: MacPherson
authors.affiliation: Health Sciences, University of Southampton, Southampton, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Roberts
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Parry
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Yardley
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: Felicity L
authors.initials: FL
authors.lastname: Bishop
mesh_terms: D026881:Acupuncture; D001291:Attitude of Health Personnel; D004185:Disability Evaluation; D006272:Health Facility Environment; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D010021:Osteopathic Medicine; D059408:Pain Management / Q000379:methods*; D026741:Physical Therapy Modalities; D010817:Physician-Patient Relations; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome
keywords: COMPLEMENTARY MEDICINE; PAIN MANAGEMENT; PRIMARY CARE; RHEUMATOLOGY