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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03328689
Study type Interventional
Source McMaster University
Contact
Status Completed
Phase N/A
Start date November 25, 2018
Completion date December 31, 2019

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