NCT03328689

Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain, Recurrent
• Low Back Pain

Interventions

Type	Name	Description
OTHER	Physical activity program	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.
OTHER	Control group standard care	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

Timeline

• Start date: 2018-11-25
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-11-01
• Last updated: 2020-02-21

Locations

1 site across 1 country: Canada