Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study

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.

More information

Identifiers

ORCID for Katherine Bradbury: orcid.org/0000-0001-5513-7571

ORCID for Miz Al-Abbadey: orcid.org/0000-0002-6307-9196

ORCID for Maddy Greville-Harris: orcid.org/0000-0001-8191-9614

ORCID for Lisa Roberts: orcid.org/0000-0003-2662-6696

ORCID for Lucy Yardley: orcid.org/0000-0002-3853-883X

ORCID for Felicity L. Bishop: orcid.org/0000-0002-8737-6662

Catalogue record

Export record

Altmetrics