ProtocolInternational Journal of Clinical Trials

Publication:
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

Int J Clin Trials. 2019;6(1):23-32.DOI10.18203/2349-3259.ijct20190258

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Abstract

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).

Keywords

Affiliations

  1. Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia Physiotherapy Department, College of Applied Medical Science, Taif University, Taif, Saudi Arabia
  2. Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia
  3. Charles Perkins Centre, Prevention Research Collaboration, School of Public Health, The University of Sydney, Sydney, Australia
  4. Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia School of Public Health, The University of Sydney, Sydney, Australia

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