Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

McMaster University

Status: Completed

Conditions: Low Back Pain, Recurrent; Low Back Pain

Treatments: Other: Physical activity program; Other: Control group standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03328689

Back2LiveWell2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Physical activity in the community

Experimental group

Description:

The physical activity program will include an individualized exercise program delivered in community exercise facility plus education..

Treatment:

Other: Physical activity program

Control group standard care

Active Comparator group

Description:

Participants from the control group will receive no additional intervention other than being encouraged to continue with their physiotherapists or chiropractor recommendation which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity.

Treatment:

Other: Control group standard care