Bradbury, Katherine, Al-Abbadey, Miz, Carnes, Dawn, Dimitrov, Borislav, Eardley, Susan, Fawkes, Carol, Foster, Jo, Greville-Harris, Maddy, Harvey, J. Matthew, Leach, Janine, Lewith, George, MacPherson, Hugh, Roberts, Lisa, Parry, Laura, Yardley, Lucy and Bishop, Felicity L. (2016) Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study. BMJ Open, 6 (5), 1-31, [e012209]. (doi:10.1136/bmjopen-2016-012209).
Abstract
Introduction: 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.
Methods and analysis: 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 sub-sample 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 treatment-enhancing communication practices.
Ethics and dissemination: 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 review journal articles, conferences, and a stakeholder workshop.
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