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

Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study
Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study
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.
health knowledge, attitudes, practice, low back pain, placebo effects, therapeutic relationship, complementary therapies
1-31
Bradbury, Katherine
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Al-Abbadey, Miz
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Carnes, Dawn
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Dimitrov, Borislav
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Eardley, Susan
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Fawkes, Carol
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Foster, Jo
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Greville-Harris, Maddy
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Harvey, J. Matthew
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Leach, Janine
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Lewith, George
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MacPherson, Hugh
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Roberts, Lisa
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Parry, Laura
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Yardley, Lucy
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Bishop, Felicity L.
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Bradbury, Katherine
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Al-Abbadey, Miz
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Carnes, Dawn
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Dimitrov, Borislav
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Eardley, Susan
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Fawkes, Carol
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Foster, Jo
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Greville-Harris, Maddy
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Harvey, J. Matthew
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Leach, Janine
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Lewith, George
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MacPherson, Hugh
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Roberts, Lisa
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Parry, Laura
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Yardley, Lucy
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Bishop, Felicity L.
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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. (doi:10.1136/bmjopen-2016-012209).

Record type: Article

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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More information

Accepted/In Press date: 13 April 2016
e-pub ahead of print date: 27 May 2016
Keywords: health knowledge, attitudes, practice, low back pain, placebo effects, therapeutic relationship, complementary therapies
Organisations: Faculty of Health Sciences, Primary Care & Population Sciences

Identifiers

Local EPrints ID: 392907
URI: https://eprints.soton.ac.uk/id/eprint/392907
PURE UUID: ccec0266-eae6-4359-b777-6084333bd98d
ORCID for Katherine Bradbury: ORCID iD orcid.org/0000-0001-5513-7571
ORCID for Miz Al-Abbadey: ORCID iD orcid.org/0000-0002-6307-9196
ORCID for Felicity L. Bishop: ORCID iD orcid.org/0000-0002-8737-6662

Catalogue record

Date deposited: 19 Apr 2016 09:05
Last modified: 06 Jun 2018 12:47

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Contributors

Author: Miz Al-Abbadey ORCID iD
Author: Dawn Carnes
Author: Borislav Dimitrov
Author: Susan Eardley
Author: Carol Fawkes
Author: Jo Foster
Author: Maddy Greville-Harris
Author: J. Matthew Harvey
Author: Janine Leach
Author: George Lewith
Author: Hugh MacPherson
Author: Lisa Roberts
Author: Laura Parry
Author: Lucy Yardley

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