Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial

Sarah L Krein, Reema Kadri, Maria Hughes, Eve A Kerr, John D Piette, Rob Holleman, Hyungjin Myra Kim, Caroline R Richardson, Sarah L Krein, Reema Kadri, Maria Hughes, Eve A Kerr, John D Piette, Rob Holleman, Hyungjin Myra Kim, Caroline R Richardson

Abstract

Background: Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program.

Objective: The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability.

Methods: A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points.

Results: Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant.

Conclusions: Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements.

Trial registration: ClinicalTrials.gov NCT00694018; https://ichgcp.net/clinical-trials-registry/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E).

Keywords: Internet; chronic pain; exercise therapy; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Mean RDQ scores (top) and MOS functional interference scores (bottom). A and B: full sample, C and D: patients with baseline RDQ scores ≥ 4.

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