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.
Highlights
Physical activity plays an important role in the management of chronic low back pain (LBP)
The participants allocated to the control group will receive sham health coaching and a sham activity monitor
This 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 Low back pain (LBP)
Summary
Design This study will be a parallel randomised controlled trial (RCT) conducted at two outpatient physical therapy clinics in Presidente Prudente, Brazil. This protocol conforms to the Consolidated Standard of Reporting Trials (CONSORT) Statement and is registered at ClinicalTrials.gov (NCT03200509). Multimodal physical activity intervention group Participants randomised to the intervention group will receive, in addition to the exercise programme, a health coaching programme together with an activity monitor. The activity monitor data will be uploaded while the participants are attending the group exercise classes and the physiotherapist will use these data to provide feedback on the amount of physical activity during the health coaching sessions. Control group The participants allocated to the control group will receive, in addition to the exercise programme, sham health coaching and a sham activity monitor.
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