Clinical trial NCT03200509: Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain
Official title: 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: PAyBACK Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: nonspecific low back pain
chronic pain
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2017-06-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 programs for chronic LBP is that these programs are not designed to change patient's behaviour toward an active lifestyle. Therefore, the objective of this study is to 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.


Eligibility criteria: Inclusion Criteria:

* Chronic nonspecific LBP, defined as pain and discomfort localised below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration

Exclusion Criteria:

* Serious spine pathology (e.g. tumors, fractures, and inflammatory diseases)
* Nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve)
* Spinal surgery
* Pregnancy
* Illiteracy
* Insufficient understanding of the Portuguese language
* Cardiorespiratory Diseases fibromyalgia or any other musculoskeletal condition that may affect activity and movement will be excluded

Primary outcomes:
measure: Physical activity levels - Counts per minute
timeFrame: Post-intervention (i.e. 3 months after randomisation)
measure: Pain intensity
timeFrame: Post-intervention (i.e. 3 months after randomisation)
measure: Disability
timeFrame: Post-intervention (i.e. 3 months after randomisation)
Secondary outcomes:
measure: Physical activity levels - Counts per minute
timeFrame: 6 and 12-month assessment after randomisation
measure: Pain intensity
timeFrame: 6 and 12-month assessment after randomisation
measure: Disability
timeFrame: 6 and 12-month assessment after randomisation
measure: Physical activity levels - light physical activity
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Physical activity levels - moderate-to-vigorous physical activity
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Physical activity levels - steps
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Sedentary behavior
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Self-reported physical activity level
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Self-reported sedentary behavior
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Depression
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: General quality of life
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Pain self-efficacy
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Weight-related outcomes - Body mass index
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Weight-related outcomes - Waist-to-hip circumference
timeFrame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
measure: Global Perceived Effect Scale (GPES)
timeFrame: Post-intervention (i.e. 3 months after randomisation)
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Sao Paulo State University
state: Sao Paulo
Study officials:
References:
citation: Oliveira CB, Franco MR, Maher CG, Tiedemann A, Silva FG, Damato TM, Nicholas MK, Christofaro DGD, Pinto RZ. 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. Trials. 2018 Jan 15;19(1):40. doi: 10.1186/s13063-017-2436-z.
citation: Oliveira CB, Christofaro DGD, Maher CG, Franco MR, Tiedemann A, Silva FG, Damato TM, Nicholas MK, Pinto RZ. Adding Physical Activity Coaching and an Activity Monitor Was No More Effective Than Adding an Attention Control Intervention to Group Exercise for Patients With Chronic Nonspecific Low Back Pain (PAyBACK Trial): A Randomized Trial. J Orthop Sports Phys Ther. 2022 May;52(5):287-299. doi: 10.2519/jospt.2022.10874.