Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial protocol

Hosam Alzahrani, Martin Mackey, Emmanuel Stamatakis, Marina B. Pinheiro, Debra Shirley



Background: The lifetime prevalence of low back pain (LBP) has been reported to be as high as 84% worldwide. Around 23% of the population has chronic non-specific LBP. Despite the potential health benefits of walking, few studies have investigated its effectiveness in people with non-specific LBP. The primary objective is to examine the efficacy of a Fitbit facilitated walking intervention in people with LBP with medium or high risk of chronicity in reducing disability and pain. The secondary objective is to investigate the efficacy of a Fitbit facilitated walking intervention in increasing physical activity levels in people with LBP.

Methods: This prospective, randomised controlled trial will involve 68 participants. This study will recruit participants who are aged 18 years or over, have been diagnosed with non-specific LBP with medium or high risk of chronicity and classified as physically inactive. Participants will be randomised into two groups: usual physiotherapy care (n=34) and usual physiotherapy care plus Fitbit facilitated walking intervention program (n=34). The treatment duration will be 8 weeks. Primary outcomes for this study are disability and pain. Secondary outcomes include physical activity level and walking steps, depression, fear of movement and pain catastrophising. The outcomes will be assessed at baseline, post-intervention and 26 weeks post-randomisation follow-up.

Conclusions: The results of this study will provide empirical evidence on the efficacy of a Fitbit facilitated walking intervention program, when added to usual care, in a clinical setting for improving disability and pain, and other clinical outcomes in people with LBP.

Trial Registration: Australian New Zealand clinical trials registry (Number ACTRN12617001404314).


Low back pain, Physical activity, Walking, Fitbit, Randomised controlled trial, Protocol

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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(6):2028-37.

Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000;13(3):205-17.

Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012;379(9814):482-91.

Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010;24(6):769-81.

Stefane T, dos Santos AM, Marinovic A, Hortense P. Chronic low back pain:pain intensity, disability and quality of life. Acta Paul Enferm. 2013;26(1):14-20.

Valat JP. Factors involved in progression to chronicity of mechanical low back pain. Joint Bone Spine. 2005;72(3):193-5.

Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain. 2000;84(1):95-103.

Leung L. Pain catastrophizing:an updated review. Indian J Psychol Med. 2012;34(3):204-17.

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(2):157-68.

Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain:systematic review. Rev Saude Publica. 2015;49.

Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, et al. A primary care back pain screening tool:identifying patient subgroups for initial treatment. Arthritis Rheum. 2008;59(5):632-41.

Robinson HS, Dagfinrud H. Reliability and screening ability of the StarT Back screening tool in patients with low back pain in physiotherapy practice, a cohort study. BMC Musculoskelet Disord. 2017;18(1):232.

Sowden G, Hill J, Konstantinou K, Khanna M, Main C, Salmon P, et al. Targeted treatment in primary care for low back pain:the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281)2011.

Foster NE, Mullis R, Hill JC, Lewis M, Whitehurst DG, Doyle C, et al. Effect of stratified care for low back pain in family practice (IMPaCT Back):a prospective population-based sequential comparison. Ann Fam Med. 2014;12(2):102-11.

O'Sullivan P. It's time for change with the management of non-specific chronic low back pain. Br J Sports Med. 2012;46(4):224-7.

Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006;332(7555):1430-1434.

Marshall PWM, Schabrun S, Knox MF. Physical activity and the mediating effect of fear, depression, anxiety, and catastrophizing on pain related disability in people with chronic low back pain. PloS one. 2017;12(7):e0180788.

Verbunt JA, Seelen HA, Vlaeyen JW, van der Heijden GJ, Knottnerus JA. Fear of injury and physical deconditioning in patients with chronic low back pain. Arch Phys Med Rehabil. 2003;84(8):1227-32.

Vlaeyen JW, Kole-Snijders AM, Boeren RG, van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain. 1995;62(3):363-72.

Lin CW, McAuley JH, Macedo L, Barnett DC, Smeets RJ, Verbunt JA. Relationship between physical activity and disability in low back pain:a systematic review and meta-analysis. Pain. 2011;152(3):607-13.

Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity:the evidence. Canadian Med Assoc J. 2006;174(6):801-9.

Hortobágyi T, Rutgers H. The Future of Health and Fitness. A plan for getting Europe active by 2025. 2014.

Siegel PZ, Brackbill RM, Heath GW. The Epidemiology of Walking for Exercise - Implications for Promoting Activity among Sedentary Groups. Am J Public Health. 1995;85(5):706-10.

Vanti C, Andreatta S, Borghi S, Guccione AA, Pillastrini P, Bertozzi L. The effectiveness of walking versus exercise on pain and function in chronic low back pain:a systematic review and meta-analysis of randomized trials. Disabil Rehabil. 2017: 1-11.

Sitthipornvorakul E, Klinsophon T, Sihawong R, Janwantanakul P. The effects of walking intervention in patients with chronic low back pain: A meta-analysis of randomized controlled trials. Musculoskelet Sci Pract. 2018;34:38-46.

Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, et al. Using pedometers to increase physical activity and improve health:a systematic review. JAMA. 2007;298(19):2296-304.

Ogilvie D, Foster CE, Rothnie H, Cavill N, Hamilton V, Fitzsimons CF, et al. Interventions to promote walking: systematic review. BMJ. 2007;334(7605):1204.

Diaz KM, Krupka DJ, Chang MJ, Peacock J, Ma Y, Goldsmith J, et al. FITBIT(®):An accurate and reliable device for wireless physical activity tracking. Int J Cardiol. 2015;185:138-40.

Evenson KR, Goto MM, Furberg RD. Systematic review of the validity and reliability of consumer-wearable activity trackers. Int J Behav Nutr Phys Act. 2015;12:159.

Cadmus-Bertram L, Marcus BH, Patterson RE, Parker BA, Morey BL. Use of the Fitbit to Measure Adherence to a Physical Activity Intervention Among Overweight or Obese, Postmenopausal Women: Self-Monitoring Trajectory During 16 Weeks. JMIR Mhealth Uhealth. 2015;3(4):e96.

Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726-32.

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire:12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381-95.

Canadian Society for Exercise Physiology. Physical Activity and Readiness Questionnaire (PAR-Q) and You; 2002. Available at: cmfiles/publications/parq/par-q.pdf. Accessed on 13 July 2018.

Murtezani A, Hundozi H, Orovcanec N, Sllamniku S, Osmani T. A comparison of high intensity aerobic exercise and passive modalities for the treatment of workers with chronic low back pain:a randomized, controlled trial. Eur J Phys Rehabil Med. 2011;47(3):359-66.

Sealed Envelope Ltd. Power calculator for continuous outcome superiority trial; 2012. Available at: continuous-superiority/. Accessed 26 September 2017.

Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?”. Med Sci Sports Exerc. 2008;40(7 Suppl):S537-43.

Tudor-Locke C, Bassett DR. How many steps/day are enough? Sports Med. 2004;34(1):1-8.

Rowe DA, Welk GJ, Heil DP, Mahar MT, Kemble CD, Calabro MA, et al. Stride rate recommendations for moderate-intensity walking. Med Sci Sports Exerc. 2011;43(2):312-8.

Abel M, Hannon J, Mullineaux D, Beighle A. Determination of step rate thresholds corresponding to physical activity intensity classifications in adults. J Physical Activity Health. 2011;8(1):45-51.

Borg G. Borg's perceived exertion and pain scales, Champaign, IL. Human Kinetics, 1998.

CQ University Australia. 10,000 Steps Website; 2016.

Koes BW, van Tulder M, Lin CW, Macedo LG, McAuley J, Maher C. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010;19(12):2075-94.

National Guideline C. National Institute for Health and Care Excellence: Clinical Guidelines. Low Back Pain and Sciatica in Over 16s:Assessment and Management. London: National Institute for Health and Care Excellence (UK) Copyright (c) NICE, 2016; 2016.

Davies C, Joyner K, Van Itallie A, Mummery K. Usefulness and usability of the 10,000 steps website within a sample of current step log users. J Sci Med Sport. 2010;12:151-2.

Fitbit. Make Fitness a Lifestyle with Flex. Available at: Accessed on 3 October 2018.

Sushames A, Edwards A, Thompson F, McDermott R, Gebel K. Validity and Reliability of Fitbit Flex for Step Count, Moderate to Vigorous Physical Activity and Activity Energy Expenditure. PLoS One. 2016;11(9):e0161224.

Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001;81(2):776-88.

Haas M, Jacobs GE, Raphael R, Petzing K. Low back pain outcome measurement assessment in chiropractic teaching clinics:responsiveness and applicability of two functional disability questionnaires. J Manipulative Physiol Ther. 1995;18(2):79-87.

Gould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: developing and using illustrated patient simulations to collect the data. J Clin Nurs. 2001;10(5):697-706.

Olaogun MOB, Adedoyin RA, Ikem IC, Anifaloba OR. Reliability of rating low back pain with a visual analogue scale and a semantic differential scale. Physiother Theory Pract. 2009;20(2):135-42.

Rowlands AV, Mirkes EM, Yates T, Clemes S, Davies M, Khunti K, et al. Accelerometer-assessed Physical Activity in Epidemiology:Are Monitors Equivalent? Medicine and science in sports and exercise. 2017.

Kongsvold AM. Validation of the AX3 accelerometer for detection of common daily activties and postures. NTNU; 2016.

Feng Y, Wong CK, Janeja V, Kuber R, Mentis HM. Comparison of tri-axial accelerometers step-count accuracy in slow walking conditions. Gait Posture. 2017;53:11-6.

Godfrey A, Del Din S, Barry G, Mathers JC, Rochester L. Within trial validation and reliability of a single tri-axial accelerometer for gait assessment. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:5892-5.

Hickey A, Del Din S, Rochester L, Godfrey A. Detecting free-living steps and walking bouts:validating an algorithm for macro gait analysis. Physiol Meas. 2017;38(1):N1-N15.

Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561-71.

Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8.

Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment. 1995;7(4):524-32.

Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997;20(6):589-605.

Osman A, Barrios FX, Gutierrez PM, Kopper BA, Merrifield T, Grittmann L. The Pain Catastrophizing Scale:further psychometric evaluation with adult samples. J Behav Med. 2000;23(4):351-65.

Miller RP, Kori S, D T. The Tampa Scale for Kinesiophobia. Clin J Pain. 1991;7(1):51-2.

Lundberg MKE, Styf J, Carlsson SG. A psychometric evaluation of the Tampa Scale for Kinesiophobia — from a physiotherapeutic perspective. Physiother Theory Pract. 2009;20(2):121-33.

Physical Activity Guidelines Advisory Committee. Physical activity guidelines advisory committee report, 2008. Washington, DC:US Department of Health and Human Services. 2008;2008:A1-H14.

Obeid JS, McGraw CA, Minor BL, Conde JG, Pawluk R, Lin M, et al. Procurement of shared data instruments for Research Electronic Data Capture (REDCap). J Biomed Inform. 2013;46(2):259-65.

Gupta SK. Intention-to-treat concept:A review. Perspect Clin Res. 2011;2(3):109-12.

Zale EL, Ditre JW. Pain-Related Fear, Disability, and the Fear-Avoidance Model of Chronic Pain. Curr Opin Psychol. 2015;5:24-30.

Meyer K, Tschopp A, Sprott H, Mannion AF. Association between catastrophizing and self-rated pain and disability in patients with chronic low back pain. J Rehabil Med. 2009;41(8):620-5.

Picavet HS, Vlaeyen JW, Schouten JS. Pain catastrophizing and kinesiophobia:predictors of chronic low back pain. Am J Epidemiol. 2002;156(11):1028-34.

Hanney WJ, Kolber MJ, Beekhuizen KS. Implications for Physical Activity in the Population With Low Back Pain. Am J Lifestyle Med. 2008;3(1):63-70.

Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain:current state of scientific evidence. J Behav Med. 2007;30(1):77-94.

Sluka KA, O'Donnell JM, Danielson J, Rasmussen LA. Regular physical activity prevents development of chronic pain and activation of central neurons. J Appl Physiol. 2013;114(6):725-33.

Elfving B, Andersson T, Grooten W. Low levels of physical activity in back pain patients are associated with high levels of fear-avoidance beliefs and pain catastrophizing. Physiother Res Int. 2007;12(1):14-24.

Alzahrani H, Shirley D, Cheng SWM, Mackey M, Stamatakis E. Physical activity and chronic back conditions: A population-based pooled study of 60,134 adults. J Sport Health Sci. 2019.

Nelson N, Churilla JR. Physical activity, fear avoidance, and chronic non-specific pain:A narrative review. J Bodyw Mov Ther. 2015;19(3):494-9.

Kremer EF, Block A, Gaylor MS. Behavioral approaches to treatment of chronic pain:the inaccuracy of patient self-report measures. Arch Phys Med Rehabil. 1981;62(4):188-91.