Clinical trial NCT03328689: Back2LiveWell: Community Based Prevention of Back Pain Flare-ups
Official title: Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Recurrent
Low Back Pain
Keywords: prevention
exercise
randomized controlled trial
physical activity
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Macquarie University, Australia
name: University of Alberta
name: Universidade Federal do Ceara
First posted: 2017-11-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Activity limiting flare-up
timeFrame: 12 months
Secondary outcomes:
measure: Activity limiting flare-up
timeFrame: 3 and 6 months
measure: Personal Impact of low back pain
timeFrame: 3, 6, 12 months
measure: Pain intensity _NRS pain
timeFrame: 3, 6, 12 months
measure: Disability
timeFrame: 3, 6, 12 months
measure: Function
timeFrame: 3, 6, 12 months
measure: Health related Quality of Life: EQ-5D-5L
timeFrame: 3, 6, 12 months (0-100)
measure: Physical activity questionnaire
timeFrame: 3, 6, 12 months
measure: Physical activity level
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: YMCA Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Luciana Macedo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macedo LG, Richardson J, Battie MC, Hancock M, Kwan M, Hladysh G, Zhuo L. Back to living well: community-based management of low back pain: a feasibility study. Pilot Feasibility Stud. 2021 Jun 24;7(1):134. doi: 10.1186/s40814-021-00863-7.