Low Back Pain
Conditions
Keywords
nonspecific low back pain, chronic pain
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.
Interventions
OTHERPhysical Activity Intervention
Participants will receive a group exercise program, health coaching sessions and an activity monitor.
OTHERControl group
Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.
Sponsors
University of Sydney
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity levels - Counts per minute | Post-intervention (i.e. 3 months after randomisation) | Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). |
| Pain intensity | Post-intervention (i.e. 3 months after randomisation) | Numerical Rating Scale for Pain assessment (NRS) (0-10) |
| Disability | Post-intervention (i.e. 3 months after randomisation) | Roland Morris Disability Questionnaire (RMDQ) (0-24) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity levels - light physical activity | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Time spent in light physical activity will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). |
| Physical activity levels - moderate-to-vigorous physical activity | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Time spent in moderate-to-vigorous physical activity will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). |
| Physical activity levels - steps | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Number of steps will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). |
| Sedentary behavior | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Time spent in sedentary behavior will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). |
| Self-reported physical activity level | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Baecke Habitual Physical Activity Questionnaire |
| Self-reported sedentary behavior | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Questions about the time spent in sedentary behavior |
| Physical activity levels - Counts per minute | 6 and 12-month assessment after randomisation | Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). |
| General quality of life | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | EuroQol visual analogue scale (EQ-VAS) (0-100) |
| Pain self-efficacy | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Pain Self-Efficacy Questionnaire (PSEQ) (0-60) |
| Weight-related outcomes - Body mass index | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Body mass index |
| Weight-related outcomes - Waist-to-hip circumference | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | Waist-to-hip circumference |
| Global Perceived Effect Scale (GPES) | Post-intervention (i.e. 3 months after randomisation) | Perception of recovery |
| Depression | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | The Center for Epidemiological Studies - Depression (CES-D) scale (0-60) |
| Pain intensity | 6 and 12-month assessment after randomisation | Numerical Rating Scale for Pain assessment (NRS) (0-10) |
| Disability | 6 and 12-month assessment after randomisation | Roland Morris Disability Questionnaire (RMDQ) (0-24) |
Countries
Brazil
Outcome results
None listed