Back2LiveWell: Community Based Prevention of Back Pain Flare-ups
Condition: Low Back Pain, Recurrent; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the effectiveness and cost-effectiveness of
      an individualized group based exercise and education program supported in the community to a
      control group of usual care in preventing back pain flare-ups and to mitigate the negative
      consequences of subsequent episodes if they occur.
    

Detailed description: 
      Secondary objectives are to:

      • To compare the effectiveness of the two interventions in preventing an activity-limiting
      LBP flare up at 12 and 24 months.

      Secondary objectives are to:

        -  To compare the effectiveness of the interventions in mitigating the negative
           consequences of LBP.

        -  To evaluate the cost-effectiveness of the interventions in preventing activity-limiting
           LBP flare-up.

        -  To identify subgroups of individuals that may best respond to each one of the two
           interventions.

      Exploratory objectives include:

        -  evaluate the fluctuating nature of back pain using a smart phone application to collect
           pain measures once a week for 1 year (trajectories will also be evaluated to compare
           between group effects)

        -  assess adherence to physical activity using activity monitors.

        -  evaluate the relationship between activity levels and flare-ups as a method for
           understanding pain triggers and impact of activity pacing.
    

Intervention name(s): Physical activity program; Control group standard care
Intervention type(s): Other; Other
Intervention description(s): This arm will begin with PT assessment. Following this, participants will meet with a specialist who will design an individualized physical activity program. Classes will include warm up, 40 minutes of individualized exercises and a cool down that will include back pain specific exercises including core strengthening. The first 4 weeks of exercise will include a 30-minute education program. Education comprise information on back pain, efficient use of the back during daily activities, self-management, self-efficacy and pain neurophysiology. Classes will run for a 12-week period. Participants will be encouraged to attend the exercise facility at least 3 times a week. An activity monitor will be provided to all participants. We will use group classes to facilitate the development of social support.; Participants from the control group will receive usual care which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity.
Participants in the control group will also receive and activity monitor for collection of physical activity data. This activity monitor may also be used for positive feedback and activity reinforcement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; exercise; randomized controlled trial; physical activity