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

Author(s)

Oliveira, Crystian B. ^[1] ; Franco, Marcia R. ^[1] ; Maher, Chris G. ^{[2, 3]} ; Tiedemann, Anne ^{[2, 3]} ; Silva, Fernanda G. ^[1] ; Damato, Tatiana M. ^[1] ; Nicholas, Michael K. ^[4] ; Christofaro, Diego G. D. ^[5] ; Pinto, Rafael Z. ^{[6, 1]}

Affiliation

^[1] Sao Paulo State Univ UNESP, Fac Sci & Technol, Dept Phys Therapy, Presidente Prudente, SP - Brazil

^[2] Univ Sydney, Sydney Med Sch, Sch Publ Hlth, Sydney, NSW - Australia

^[3] Sydney Local Hlth Dist, Inst Musculoskeletal Hlth, Sydney, NSW - Australia

^[4] Univ Sydney, Royal North Shore Hosp, Pain Management Res Inst, Sydney, NSW - Australia

^[5] Sao Paulo State Univ UNESP, Fac Sci & Technol, Dept Phys Educ, Presidente Prudente, SP - Brazil

^[6] Univ Fed Minas Gerais, Dept Phys Therapy, Belo Horizonte, MG - Brazil

• Document type: Journal article
• Source: Trials; v. 19, JAN 15 2018.
• Web of Science Citations: 5

Abstract

Background: Physical 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. Methods: This 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. Discussion: 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 LBP. (AU)

• FAPESP's process: 14/14077-8 - Investigating the role of physical activity domains in the prognosis of non-specific low back pain
• Grantee: Rafael Zambelli de Almeida Pinto
• Support Opportunities: Research Grants - Young Investigators Grants
• FAPESP's process: 15/07704-9 - Effects of senior dance on risk factors for falls in older adults: a randomised controlled clinical trial
• Grantee: Marcia Rodrigues Franco Zambelli
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• FAPESP's process: 16/03826-5 - Investigating the effect of a physical activity intervention enhanced with health coaching and FitBit on physical activity levels of patients with chronic low back pain: a randomized controlled trial
• Grantee: Crystian Bitencourt Soares de Oliveira
• Support Opportunities: Scholarships in Brazil - Doctorate