The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial

Abstract

BackgroundPhysical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programmes for chronic LBP is that these programmes are not designed to change patients’ behaviour toward an active lifestyle. Therefore, we will investigate the short- and long-term efficacy of a multimodal intervention, consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability, in patients with chronic, nonspecific LBP.MethodsThis study will be a two-group, single-blind, randomised controlled trial. One hundred and sixty adults with chronic, nonspecific LBP will be recruited. Participants allocated to both groups will receive a group exercise programme. In addition, the intervention group will receive health coaching sessions (i.e. assisting the participants to achieve their physical activity goals) and an activity monitor (i.e. Fitbit Flex). The participants allocated to the control group will receive sham health coaching (i.e. encouraged to talk about their LBP or other problems, but without any therapeutic advice from the physiotherapist) and a sham activity monitor. Outcome measures will be assessed at baseline and at 3, 6 and 12 months post randomisation. The primary outcomes will be physical activity, measured objectively with an accelerometer, as well as pain intensity and disability at 3 months post randomisation. Secondary outcomes will be physical activity, pain intensity and disability at 6 and 12 months post randomisation as well as other self-report measures of physical activity and sedentary behaviour, depression, quality of life, pain self-efficacy and weight-related outcomes at 3, 6, and 12 months post randomisation.DiscussionThis study is significant as it will be the first study to investigate whether a multimodal intervention designed to increase physical activity levels reduces pain and disability, and increases physical activity levels compared to a control intervention in patients with chronic LBP.Trial registrationClinicalTrials.gov, ID: NCT03200509. Registered on 28 June 2017.Electronic supplementary materialThe online version of this article 10.1186/s13063-017-2436-z) contains supplementary material, which is available to authorized users.

Physical activity as a prognostic factor of pain intensity and disability in patients with low back pain: A systematic review

“…The importance of physical activity among patients with LBP has been increasingly investigated in recent times (Morelhao et al, ; Oliveira, Franco, et al, ). However, the overall quality of evidence was low‐quality evidence which suggests that better designed studies are still needed to draw definitive conclusions on this topic.…”

Physical activity and disability measures in chronic non-specific low back pain: a study of responsiveness

“…Nevertheless, since the publication of this systematic review, we identified at least four randomized controlled trials investigating the efficacy of interventions specifically designed to improve physical activity levels in patients with CLBP. Of these, one published trial 37 used a self-reported physical activity measure as an outcome but did not provide information on disability measures and three trial protocols 38–40 collecting concomitant information on self-reported and/or objective physical activity and disability measures. The results of these trials will help understanding the value of this type of intervention on physical activity measures as well as on clinical outcome, such as disability and pain intensity.…”

Self‐Report Measures of Physical Activity

“…No randomized controlled trials (RCTs) in MSK populations that used the BPAQ questionnaire could be identified; only one protocol was identified .…”

“…No RCTs in MSK populations that used the BPAQ could be identified, and only one protocol was identified . The BPAQ was designed for use in epidemiological studies only.…”