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Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial

INTRODUCTION: Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that...

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Autores principales: Robson, Emma K, Kamper, Steven J, Davidson, Simon, Viana da Silva, Priscilla, Williams, Amanda, Hodder, Rebecca K, Lee, Hopin, Hall, Alix, Gleadhill, Connor, Williams, Christopher M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6731930/
https://www.ncbi.nlm.nih.gov/pubmed/31481555
http://dx.doi.org/10.1136/bmjopen-2019-029290
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author Robson, Emma K
Kamper, Steven J
Davidson, Simon
Viana da Silva, Priscilla
Williams, Amanda
Hodder, Rebecca K
Lee, Hopin
Hall, Alix
Gleadhill, Connor
Williams, Christopher M
author_facet Robson, Emma K
Kamper, Steven J
Davidson, Simon
Viana da Silva, Priscilla
Williams, Amanda
Hodder, Rebecca K
Lee, Hopin
Hall, Alix
Gleadhill, Connor
Williams, Christopher M
author_sort Robson, Emma K
collection PubMed
description INTRODUCTION: Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS: The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION: This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12617001288314.
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spelling pubmed-67319302019-09-20 Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial Robson, Emma K Kamper, Steven J Davidson, Simon Viana da Silva, Priscilla Williams, Amanda Hodder, Rebecca K Lee, Hopin Hall, Alix Gleadhill, Connor Williams, Christopher M BMJ Open Public Health INTRODUCTION: Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS: The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION: This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12617001288314. BMJ Publishing Group 2019-09-03 /pmc/articles/PMC6731930/ /pubmed/31481555 http://dx.doi.org/10.1136/bmjopen-2019-029290 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Public Health
Robson, Emma K
Kamper, Steven J
Davidson, Simon
Viana da Silva, Priscilla
Williams, Amanda
Hodder, Rebecca K
Lee, Hopin
Hall, Alix
Gleadhill, Connor
Williams, Christopher M
Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial
title Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial
title_full Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial
title_fullStr Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial
title_full_unstemmed Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial
title_short Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial
title_sort healthy lifestyle program (help) for low back pain: protocol for a randomised controlled trial
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6731930/
https://www.ncbi.nlm.nih.gov/pubmed/31481555
http://dx.doi.org/10.1136/bmjopen-2019-029290
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