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.
*Centre for Health and Rehabilitation Technologies, University of Ulster, Newtownabbey, County Antrim, UK
‡School of Psychology, University of Ulster, Londonderry, Co Londonderry, UK
†UKCRC Centre of Excellence for Public Health (NI), Queens’ University Belfast, UK
∥Frontier Science Scotland, Kingussie, UK
§School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA
¶Walking Behavior Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA
#Centre for Physiotherapy Research, University of Otago, North Dunedin, New Zealand
**School of Public Health, Physiotherapy and Population Science, University College Dublin, Dublin, Ireland
Trial Registration: [ISRCTN67030896].
The authors declare no conflict of interest. Supported by the Physiotherapy Research Foundation (PRF/08/1), Chartered Society of Physiotherapy, London, UK and funding for a PhD studentship from the Department of Employment and Learning, Belfast, Co. Antrim, Northern Ireland.
M.A.T. and S.Mc.D. conceived the idea for this study. S.Mc.D., M.A.T., G.D.B., D.A.H., A.D., S.O.N., and I.B. were involved in developing the original idea for funding and were coapplicants on the successful funding proposal. M.A.T., C.T.-L., and S.Mc.D. devised a detailed walking program.
Reprints: Suzanne M. McDonough, PhD, Health and Rehabilitation Sciences Research Centre, University of Ulster, Shore Road, Newtownabbey, Co Antrim, BT37 0QB, UK (e-mail: email@example.com).
Received May 8, 2012
Accepted November 23, 2012