Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

NCT ID: NCT03328689

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-25
• Study Completion Date: 2019-12-31

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.

Conditions

Low Back Pain, Recurrent; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Physical activity in the community

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

Group Type: EXPERIMENTAL

Physical activity program

Intervention Type: OTHER

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.

Control group standard care

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.

Group Type: ACTIVE_COMPARATOR

Control group standard care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Macquarie University, Australia

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Universidade Federal do Ceara

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Luciana Macedo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana Macedo, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

YMCA Hamilton

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34167584 (View on PubMed)

Other Identifiers

Back2LiveWell2017

Identifier Type: -

Identifier Source: org_study_id