Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial

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.

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.

Inclusion criteria:

Participants will be included if they meet the following criteria

• Have been discharged <3 months from physiotherapy, chiropractic or osteopathic care following a course of treatment for LBP (pain in the area between the 12th rib and buttock crease)
• Have non-specific LBP which is pain not attributed to a specific diagnosis such as sciatica, ankylosing spondylitis, vertebral fracture, etc.
• Non-specific LBP sometimes called mechanical LBP accounts for ~85% of LBP diagnosis.
• Between 18 and 80 years of age

Exclusion criteria:

Participants will be excluded if they meet the following criteria:

• Ongoing high pain intensity, defined as pain intensity of 6 or more on a 0-10 point scale. The cut off of 6/10 is used in the literature to dichotomise low/moderate to high pain intensity.
• Co-morbidity preventing participation in physical activity evaluated using the Physical Activity Readiness Questionnaire (PAR-Q) from the American College of Sports Medicine guidelines
• Inadequate English to complete outcome measures
• Currently participating in an exercise program similar to the one we will evaluate.
• History of spine surgery