Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain, Recurrent
- Sponsor
- McMaster University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Activity limiting flare-up
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Luciana Macedo
Assistant Professor
McMaster University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Activity limiting flare-up
Time Frame: 12 months
* flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15 * activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation. Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above. Flare-up will be collected once a week for 1 year
Secondary Outcomes
- Activity limiting flare-up(3 and 6 months)
- Personal Impact of low back pain(3, 6, 12 months)
- Pain intensity _NRS pain(3, 6, 12 months)
- Disability(3, 6, 12 months)
- Function(3, 6, 12 months)
- Health related Quality of Life: EQ-5D-5L(3, 6, 12 months (0-100))
- Physical activity questionnaire(3, 6, 12 months)
- Physical activity level(3, 6, 12 months)