Pedometer-driven Walking for Chronic Low Back Pain: A Feasibility Randomized Controlled Trial

Objectives:To evaluate the feasibility of an RCT of a pedometer-driven walking program and education/advice to remain active compared with education/advice only for treatment of chronic low back pain (CLBP). Methods:Fifty-seven participants with CLBP recruited from primary care were randomly allocated to either: (1) education/advice (E, n=17) or (2) education/advice plus an 8-week pedometer-driven walking program (EWP, n=40). Step targets, actual daily step counts, and adverse events were recorded in a walking diary over the 8 weeks of intervention for the EWP group only. All other outcomes (eg, functional disability using the Oswestry Disability Questionnaire (ODQ), pain scores, physical activity (PA) measurement etc.) were recorded at baseline, week 9 (immediately post-intervention), and 6 months in both groups. Results:The recruitment rate was 22% and the dropout rate was lower than anticipated (13% to 18% at 6 mo). Adherence with the EWP was high, 93% (n=37/40) walked for ≥6 weeks, and increased their steps/day (mean absolute increase in steps/d, 2776, 95% confidence interval [CI], 1996-3557) by 59% (95% CI, 40.73%-76.25%) from baseline. Mean percentage adherence with weekly step targets was 70% (95% CI, 62%-77%). Eight (20%) minor-related adverse events were observed in 13% (5/40) of the participants. The EWP group participants demonstrated an 8.2% point improvement (95% CI, −13 to −3.4) on the ODQ at 6 months compared with 1.6% points (95% CI, –9.3 to 6.1) for the E group (between group d=0.44). There was also a larger mean improvement in pain (d=0.4) and a larger increase in PA (d=0.59) at 6 months in EWP. Discussion:This preliminary study demonstrated that a main RCT is feasible. EWP was safe and produced a real increase in walking; CLBP function and pain improved, and participants perceived a greater improvement in their PA levels. These improvements require confirmation in a fully powered RCT.

[1]  A. Gray,et al.  The economic burden of back pain in the UK , 1999, Pain.

[2]  M. Tully,et al.  Functional management of ankle sprains: what volume and intensity of walking is undertaken in the first week postinjury , 2012, British Journal of Sports Medicine.

[3]  Zhang Jing,et al.  Guideline on missing data in confirmatory clinical trials , 2012 .

[4]  David E. Goodrich,et al.  Adverse events among high-risk participants in a home-based walking study: a descriptive study , 2007, The international journal of behavioral nutrition and physical activity.

[5]  J. D. Childs,et al.  A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale , 2010, BMC musculoskeletal disorders.

[6]  C. Tudor-Locke,et al.  The Back 2 Activity Trial: education and advice versus education and advice plus a structured walking programme for chronic low back pain , 2010, BMC musculoskeletal disorders.

[7]  N. Ntoumanis,et al.  Communication style and exercise compliance in physiotherapy (CONNECT). A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods , 2012, BMC Musculoskeletal Disorders.

[8]  Jacob Cohen Statistical Power Analysis for the Behavioral Sciences , 1969, The SAGE Encyclopedia of Research Design.

[9]  Ilse de Bourdeaudhuij,et al.  How many steps/day are enough? For older adults and special populations , 2011, The international journal of behavioral nutrition and physical activity.

[10]  G. Waddell,et al.  The Back Book: the best way to deal with back pain , 2002 .

[11]  S. Milosavljevic,et al.  The effectiveness of walking as an intervention for low back pain: a systematic review , 2010, European Spine Journal.

[12]  Catrine Tudor-Locke,et al.  How Many Steps/Day Are Enough? Preliminary Pedometer Indices for Public Health , 2004 .

[13]  I. Olkin,et al.  Using pedometers to increase physical activity and improve health: a systematic review. , 2007, JAMA.

[14]  M. Tully,et al.  UNISTEP (university students exercise and physical activity) study: a pilot study of the effects of accumulating 10,000 steps on health and fitness among university students. , 2011, Journal of physical activity & health.

[15]  Peter Croft,et al.  Interpreting Change Scores for Pain and Functional Status in Low Back Pain: Towards International Consensus Regarding Minimal Important Change , 2008, Spine.

[16]  S. McDonough,et al.  Exercise and Auricular Acupuncture for Chronic Low-back Pain: A Feasibility Randomized-controlled Trial , 2012, The Clinical journal of pain.

[17]  Martin Underwood,et al.  Early management of persistent non-specific low back pain: summary of NICE guidance , 2009, BMJ : British Medical Journal.

[18]  M. Thorogood,et al.  Interventions for promoting physical activity. , 2005, The Cochrane database of systematic reviews.

[19]  Walking and measurement. , 2008, Medicine and science in sports and exercise.

[20]  Stephan Milosavljevic,et al.  Utility of the RT3 triaxial accelerometer in free living: an investigation of adherence and data loss. , 2010, Applied ergonomics.

[21]  P. Freedson,et al.  Amount of time spent in sedentary behaviors in the United States, 2003-2004. , 2008, American journal of epidemiology.

[22]  C. T. Orleans,et al.  Evaluating primary care behavioral counseling interventions: an evidence-based approach. , 2002, American journal of preventive medicine.

[23]  M. Tully,et al.  A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial) , 2009, BMC musculoskeletal disorders.

[24]  C. Tudor-Locke Promoting Lifestyle Physical Activity: Experiences With the First Step Program , 2009, American journal of lifestyle medicine.

[25]  W F Velicer,et al.  Stage distributions for five health behaviors in the United States and Australia. , 1999, Preventive medicine.

[26]  C. Tudor-Locke,et al.  Pedometer-determined step count guidelines for classifying walking intensity in a young ostensibly healthy population. , 2005, Canadian journal of applied physiology = Revue canadienne de physiologie appliquee.