Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Amanda Williams, John Wiggers, Kate M. O’Brien, Luke Wolfenden, Serene Yoong, Elizabeth Campbell, Emma Robson, James McAuley, Robin Haskins, Steven J. Kamper, Christopher M. Williams

Published in: BMC Musculoskeletal Disorders | Issue 1/2016

Login to get access

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, ACTRN12615000478​516, Registered 14/05/2015.
Literature
1.
Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64:2028–37.CrossRefPubMed
2.
Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012;379:482–91.CrossRefPubMed
3.
Vos T, Barber RM, Bell B, Bertozzi-Villa A, Biryukov S, Bolliger I, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386:743–800.CrossRef
4.
Arthritis and Osteoporosis Victoria. A Problem worth solving - The rising cost of musculoskeletal conditions in Australia. Elsternwick: Arthritis and Osteoporosis Victoria; 2013.
5.
Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8:8–20. Off. J. North Am. Spine Soc.CrossRefPubMed
6.
Leboeuf-Yde C. Body weight and low back pain. A systematic literature review of 56 journal articles reporting on 65 epidemiologic studies. Spine. 2000;25:226–37.CrossRefPubMed
7.
Shiri R, Karppinen J, Leino-Arjas P, Solovieva S, Viikari-Juntura E. The association between obesity and low back pain: a meta-analysis. Am J Epidemiol. 2010;171:135–54.CrossRefPubMed
8.
Heuch II, Hagen K, Zwart J-A. Body mass index as a risk factor for developing chronic low back pain: a follow-up in the Nord-Trø ndelag Health Study. Spine. 2013;38:133–9.CrossRefPubMed
9.
National Health and Medical Research Council. Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults, Adolescents and Children in Australia. National Health and Medical Research Council; 2013.
10.
Wai EK, Rodriguez S, Dagenais S, Hall H. Evidence-informed management of chronic low back pain with physical activity, smoking cessation, and weight loss. Spine J. 2008;8:195–202. Off. J. North Am. Spine Soc.CrossRefPubMed
11.
Roffey DM, Budiansky A, Coyle MJ, Wai EK. Obesity and Low Back Pain: Is There a Weight of Evidence to Support a Positive Relationship? Curr Obes Rep. 2013;2:241–50.CrossRef
12.
Linton SJ, van Tulder MW. Preventive interventions for back and neck pain problems: what is the evidence? Spine. 2001;26:778–87.CrossRefPubMed
13.
Roffey DM, Ashdown LC, Dornan HD, Creech MJ, Dagenais S, Dent RM, et al. Pilot evaluation of a multidisciplinary, medically supervised, nonsurgical weight loss program on the severity of low back pain in obese adults. Spine J. 2011;11:197–204.CrossRefPubMed
14.
Graves N, Barnett AG, Halton KA, Veerman JL, Winkler E, Owen N, et al. Cost-effectiveness of a telephone-delivered intervention for physical activity and diet. PLoS One. 2009;4:e7135.PubMedCentralCrossRefPubMed
15.
Goode AD, Reeves MM, Eakin EG. Telephone-delivered interventions for physical activity and dietary behavior change: an updated systematic review. Am J Prev Med. 2012;42:81–8.CrossRefPubMed
16.
Appel LJ, Clark JM, Yeh H-C, Wang N-Y, Coughlin JW, Daumit G, et al. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011;365:1959–68.PubMedCentralCrossRefPubMed
17.
Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the ‘cohort multiple randomised controlled trial’ design. BMJ. 2010;340:963–7.CrossRef
18.
Krismer M, van Tulder M. Strategies for prevention and management of musculoskeletal conditions. Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007;21:77–91.CrossRefPubMed
19.
O’Hara BJ, Bauman AE, Eakin EG, King L, Haas M, Allman-Farinelli M, et al. Evaluation Framework for Translational Research: Case Study of Australia’s Get Healthy Information and Coaching Service®. Health Promot Pract. 2013;14(3):380–9.CrossRefPubMed
20.
O’Hara BJ, Phongsavan P, Venugopal K, Eakin EG, Eggins D, Caterson H, et al. Effectiveness of Australia’s Get Healthy Information and Coaching Service®: translational research with population wide impact. Prev Med. 2012;55:292–8.CrossRefPubMed
21.
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000;55:68–78.CrossRefPubMed
22.
Silva MN, Markland D, Minderico CS, Vieira PN, Castro MM, Coutinho SR, et al. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description. BMC Public Health. 2008;8:234.PubMedCentralCrossRefPubMed
23.
24.
Rollnick S, Miller WR. What is motivational interviewing? Behav Cogn Psychother. 1995;23:325–34.CrossRef
25.
Palmer S, Tubbs I, Whybrow A. Health coaching to facilitate the promotion of healthy behaviour and achievement of health-related goals. Int J Health Promot Educ. 2003;41:91–3.CrossRef
26.
Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain. 1992;50:133–49.CrossRef
27.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res. 2011;63:240–52.CrossRef
28.
Roland M, Morris R. A study of the natural history of back pain: part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983;8:141–4.CrossRefPubMed
29.
International Society for the Advancement of Kinanthropometry. International Standards for Antrhopometric Assessment. Underdale: ISAK; 2001.
30.
Ware JE, Kosinski M, Turner-bowker DM, Gandek B. User’s Manual for the SF-12v2 Health Survey (With a Supplement Documenting SF-12 Health Survey). Lincoln: QualityMetric Incorporated; 2002.
31.
Lovibond PF, Lovibond SH. The structure of negative emotional states: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995;33:335–43.CrossRefPubMed
32.
Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213.CrossRefPubMed
33.
Australian Institute of Health and Welfare (AIHW). The Active Australia Survey: a guide and manual for implementation, analysis and reporting. Canberra: AIHW; 2003.
34.
Centre for Epidemiology and Research. NSW Population Health Survey. Sydney: NSW Department of Health; 2014.
35.
Babor T, Higgins-Biddle J, Saunders J, Monteiro M. AUDIT. The alcohol use disorders identification test: guidelines for use in primary care (2nd Ed). Geneva: World Health Organisation; 1992.
36.
Shiri R, Karppinen J, Leino-Arjas P, Solovieva S, Viikari-Juntura E. The association between smoking and low back pain: a meta-analysis. Am J Med. 2010;123:87. e7–35.CrossRefPubMed
37.
Williams CM, Latimer J, Maher CG, McLachlan AJ, Cooper CW, Hancock MJ, et al. PACE–the first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2010;11:169.PubMedCentralCrossRefPubMed
38.
Jensen MP, Karoly P, Huger R. The development and preliminary validation of an instrument to assess patients’ attitudes toward pain. J Psychosom Res. 1987;31:393–400.CrossRefPubMed
39.
Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–68.CrossRefPubMed
40.
41.
Proschan MA, Waclawiw MA. Practical guidelines for multiplicity adjustment in clinical trials. Control Clin Trials. 2000;21:527–39.CrossRefPubMed
42.
Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007;66:433–9.PubMedCentralCrossRefPubMed
43.
Kamper SJ, Ostelo RWJG, Knol DL, Maher CG, de Vet HCW, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010;63:760–6.CrossRefPubMed
Metadata
Title
A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol
Authors
Amanda Williams
John Wiggers
Kate M. O’Brien
Luke Wolfenden
Serene Yoong
Elizabeth Campbell
Emma Robson
James McAuley
Robin Haskins
Steven J. Kamper
Christopher M. Williams
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2016
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-016-0922-1

Other articles of this Issue 1/2016

BMC Musculoskeletal Disorders 1/2016 Go to the issue

Research article

The Munich Wrist Questionnaire (MWQ) – development and validation of a new patient-reported outcome measurement tool for wrist disorders

Research article

Associations of LBX1 gene and adolescent idiopathic scoliosis susceptibility: a meta-analysis based on 34,626 subjects

Study protocol

Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial)

Research article

Osteoarthritic changes rather than age predict outcome following arthroscopic treatment of femoroacetabular impingement in middle-aged patients

Research article

Reductions in co-contraction following neuromuscular re-education in people with knee osteoarthritis

Research article

Clinical results of endoscopic sciatic nerve decompression for deep gluteal syndrome: mean 2-year follow-up