Randomized Controlled Trial

. 2016 Feb 11:17:70.

doi: 10.1186/s12891-016-0922-1.

A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol

Amanda Williams^{1

2

3}, John Wiggers^{4

5

6}, Kate M O'Brien^{7

8

9}, Luke Wolfenden^{10

11

12}, Serene Yoong^{13

14

15}, Elizabeth Campbell^{16

17

18}, Emma Robson¹⁹, James McAuley^{20

21}, Robin Haskins²², Steven J Kamper²³, Christopher M Williams^{24

25

26

27}

Affiliations

¹ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Amanda.J.Williams@hnehealth.nsw.gov.au.
² Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Amanda.J.Williams@hnehealth.nsw.gov.au.
³ University of Newcastle, Newcastle, 2308, Australia. Amanda.J.Williams@hnehealth.nsw.gov.au.
⁴ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. John.Wiggers@hnehealth.nsw.gov.au.
⁵ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. John.Wiggers@hnehealth.nsw.gov.au.
⁶ University of Newcastle, Newcastle, 2308, Australia. John.Wiggers@hnehealth.nsw.gov.au.
⁷ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Kate.OBrien@hnehealth.nsw.gov.au.
⁸ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Kate.OBrien@hnehealth.nsw.gov.au.
⁹ University of Newcastle, Newcastle, 2308, Australia. Kate.OBrien@hnehealth.nsw.gov.au.
¹⁰ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Luke.Wolfenden@hnehealth.nsw.gov.au.
¹¹ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Luke.Wolfenden@hnehealth.nsw.gov.au.
¹² University of Newcastle, Newcastle, 2308, Australia. Luke.Wolfenden@hnehealth.nsw.gov.au.
¹³ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Serene.Yoong@hnehealth.nsw.gov.au.
¹⁴ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Serene.Yoong@hnehealth.nsw.gov.au.
¹⁵ University of Newcastle, Newcastle, 2308, Australia. Serene.Yoong@hnehealth.nsw.gov.au.
¹⁶ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Libby.Campbell@hnehealth.nsw.gov.au.
¹⁷ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Libby.Campbell@hnehealth.nsw.gov.au.
¹⁸ University of Newcastle, Newcastle, 2308, Australia. Libby.Campbell@hnehealth.nsw.gov.au.
¹⁹ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Emma.Robson@hnehealth.nsw.gov.au.
²⁰ Neuroscience Research Australia, PO Box 1170, Randwick, NSW 2031, Australia. j.mcauley@neura.edu.au.
²¹ Prince of Wales Clinical School, University of New South Wales, Randwick, 2031, Australia. j.mcauley@neura.edu.au.
²² Ambulatory Care Centre, John Hunter Hospital, Hunter New England Local Health District, Locked Bag 664 J, Newcastle, NSW 2300, Australia. Robin.Haskins@hnehealth.nsw.gov.au.
²³ The George Institute for Global Health, University of Sydney, PO Box M201, Sydney, NSW 2050, Australia. skamper@george.org.au.
²⁴ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.
²⁵ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.
²⁶ University of Newcastle, Newcastle, 2308, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.
²⁷ The George Institute for Global Health, University of Sydney, PO Box M201, Sydney, NSW 2050, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.

PMID: 26864851
PMCID: PMC4750252
DOI: 10.1186/s12891-016-0922-1

Randomized Controlled Trial

A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol

Amanda Williams et al. BMC Musculoskelet Disord. 2016.

. 2016 Feb 11:17:70.

doi: 10.1186/s12891-016-0922-1.

Authors

Affiliations

¹ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Amanda.J.Williams@hnehealth.nsw.gov.au.
² Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Amanda.J.Williams@hnehealth.nsw.gov.au.
³ University of Newcastle, Newcastle, 2308, Australia. Amanda.J.Williams@hnehealth.nsw.gov.au.
⁴ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. John.Wiggers@hnehealth.nsw.gov.au.
⁵ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. John.Wiggers@hnehealth.nsw.gov.au.
⁶ University of Newcastle, Newcastle, 2308, Australia. John.Wiggers@hnehealth.nsw.gov.au.
⁷ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Kate.OBrien@hnehealth.nsw.gov.au.
⁸ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Kate.OBrien@hnehealth.nsw.gov.au.
⁹ University of Newcastle, Newcastle, 2308, Australia. Kate.OBrien@hnehealth.nsw.gov.au.
¹⁰ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Luke.Wolfenden@hnehealth.nsw.gov.au.
¹¹ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Luke.Wolfenden@hnehealth.nsw.gov.au.
¹² University of Newcastle, Newcastle, 2308, Australia. Luke.Wolfenden@hnehealth.nsw.gov.au.
¹³ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Serene.Yoong@hnehealth.nsw.gov.au.
¹⁴ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Serene.Yoong@hnehealth.nsw.gov.au.
¹⁵ University of Newcastle, Newcastle, 2308, Australia. Serene.Yoong@hnehealth.nsw.gov.au.
¹⁶ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Libby.Campbell@hnehealth.nsw.gov.au.
¹⁷ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Libby.Campbell@hnehealth.nsw.gov.au.
¹⁸ University of Newcastle, Newcastle, 2308, Australia. Libby.Campbell@hnehealth.nsw.gov.au.
¹⁹ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Emma.Robson@hnehealth.nsw.gov.au.
²⁰ Neuroscience Research Australia, PO Box 1170, Randwick, NSW 2031, Australia. j.mcauley@neura.edu.au.
²¹ Prince of Wales Clinical School, University of New South Wales, Randwick, 2031, Australia. j.mcauley@neura.edu.au.
²² Ambulatory Care Centre, John Hunter Hospital, Hunter New England Local Health District, Locked Bag 664 J, Newcastle, NSW 2300, Australia. Robin.Haskins@hnehealth.nsw.gov.au.
²³ The George Institute for Global Health, University of Sydney, PO Box M201, Sydney, NSW 2050, Australia. skamper@george.org.au.
²⁴ Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.
²⁵ Hunter Medical Research Institute, Locked Bag 1, Hunter Region Mc, NSW 2310, Newcastle, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.
²⁶ University of Newcastle, Newcastle, 2308, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.
²⁷ The George Institute for Global Health, University of Sydney, PO Box M201, Sydney, NSW 2050, Australia. Christopher.M.Williams@hnehealth.nsw.gov.au.

PMID: 26864851
PMCID: PMC4750252
DOI: 10.1186/s12891-016-0922-1

Abstract

Background: Low back pain is a highly prevalent condition with a significant global burden. Management of lifestyle factors such as overweight and obesity may improve low back pain patient outcomes. Currently there are no randomised controlled trials that have been conducted to assess the effectiveness of lifestyle behavioural interventions in managing low back pain. The aim of this trial is to determine if a telephone-based lifestyle behavioural intervention is effective in reducing pain intensity in overweight or obese patients with low back pain, compared to usual care.

Methods/design: A randomised controlled trial will be conducted with patients waiting for an outpatient consultation with an orthopaedic surgeon at a public tertiary referral hospital within New South Wales, Australia for chronic low back pain. Patients will be randomly allocated in a 1:1 ratio to receive a lifestyle behavioural intervention (intervention group) or continue with usual care (control group). After baseline data collection, patients in the intervention group will receive a clinical consultation followed by a 6-month telephone-based lifestyle behavioural intervention (10 individually tailored sessions over a 6-month period) and patients in the control group will continue with usual care. Participants will be followed for 26 weeks and asked to undertake three self-reported questionnaires at baseline (pre-randomisation), week 6 and 26 post randomisation to collect primary and secondary outcome data. The study requires a sample of 80 participants per group to detect a 1.5 point difference in pain intensity (primary outcome) 26 weeks post randomisation. The primary outcome, pain intensity, will be measured using a 0-10 numerical rating scale.

Discussion: The study will provide robust evidence regarding the effectiveness of a lifestyle behavioural intervention in reducing pain intensity in overweight or obese patients with low back pain and inform management of these patients.

Trial registration number: Australian New Zealand Clinical Trials Registry, ACTRN12615000478516 , Registered 14/05/2015.

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Figures

**Fig. 1**
Progress of participants through the study

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A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol

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A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol

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