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Pedometer-driven walking for chronic low back pain: a feasibility randomized controlled trial
McDonough SM, Tully MA, Boyd A, O'Connor SR, Kerr DP, O'Neill SM, Delitto A, Bradbury I, Tudor-Locke C, Baxter GD, Hurley DA
The Clinical Journal of Pain 2013 Nov;29(11):972-981
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 2,776, 95% confidence interval (CI) 1,996 to 3,557) by 59% (95% CI 40.73% to 76.25%) from baseline. Mean percentage adherence with weekly step targets was 70% (95% CI 62% to 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.

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