Back to Living Well: Implementation of a Community-based Program for Low Back Pain

McMaster University

Status: Active, not recruiting

Conditions: Low Back Pain

Treatments: Other: Back to Living Well Program

Study type: Observational

Funder types: Other

Identifiers

NCT05929846

15354

Details and patient eligibility

About

Low back pain (LBP) is usually a long-term condition with episodes of improvement, remission, and recurrence. There is evidence that long term exercise combined with education and self-management is effective at reducing the negative consequences of LBP. However, problems with uptake and long-term adherence to such programs are often reported in the literature. Using best available evidence, the implementation of the BackToLivingWell (BLW) will be evaluated, a community-based online or in-person program for the prevention long term disability due to LBP through exercise and self management.

Full description

The study will evaluate the implementation of The Back to Living Well program (BLW), a sustainable community-based program for persons with persistent mild to moderate LBP. The goal of the intervention is to provide an opportunity for community dwelling persons with persistent mild to moderate LBP to learn how to safely engage in exercise and become active self-managers. Through the engagement in exercise and healthy lifestyle behaviours, the program aims to prevent activity-limiting flares as well as minimize the ongoing impact of the condition with improvements in function and quality of life.

Persons with LBP will be invited to participate in either the in-person or e-health program based on their choices. We will conduct a mixed-method study with a quantitative and a qualitative portion. This will include participants completing the program and questionnaires at baseline, 3-, 6- and 12- months, as well as longitudinal qualitative interviews at the same time points to assess: 1) barriers and facilitators to the program, 2) factors that contribute to negative and positive responses to the program. This may include how intervention outcomes are related to the program, personal and societal factors, and 3) factors that influence the selection of in-person versus online intervention.

In addition, to evaluate symptom trajectories, an ecological Momentary Assessment (EMA) will be collecting data over the same time points (baseline, 3-, 6- and 12- months). Weekly outcomes will be collected for 1-year using a smartphone application. The results of this study will provide evidence to inform future implementation of the program including strategies that could lead to better outcomes. Additionally, LiveWell specialists delivering the program and YMCA staff will be interviewed at the end of the program.

Overall, the RE-AIM framework will be used to guide our implementation. Additionally, using the Theoretical Domains Framework, the Technology Acceptance Model and the Neuromatrix Model of Pain we will construct a theory-based approach to:

1. Identify program barriers and facilitators from the perspective of the patients,
2. Identify factors contributing to negative and positive outcomes as well as outcome trajectories, including how outcomes are related to the program, personal and contextual factors and,
3. Identify factors influencing participants to select an in-person or e-health program,
4. Evaluation program specific implementation barriers and facilitators from the perspectives of the organization and care delivery perspectives.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Currently starting or enrolled in the Back to Living Well program at a YMCA in Downtown Hamilton, Les Chater, Ron Edwards, Laurier Brantford or Flamborough
• Have non-specific LBP
• History of persistent LBP for 3 or more months that is mild, moderate, or severe
• If moderate levels of pain or less (pain <6) they must have a history of flares or at least one flare within the previous year, if pain >=6, flare is not necessary.
• 18 years old or older

Exclusion criteria

• Co-morbidity preventing participation in exercise based on screening using the Physical Activity Readiness Questionnaire and later not cleared by their family physician
• Inadequate English to complete questionnaires and interviews
• Participants who are currently seeking care for LBP

Trial design

90 participants in 2 patient groups

In-Person

Description:

Participants will be assessed by a LiveWell specialist to assess functional goals and baseline capacity and design an individualized program. LiveWell specialist may also refer participants for an assessment with a physiotherapist based on a pre-defined criteria including redflag for serious conditions. Participants will engage in a 12-week program consisting of 45 minute sessions 3 times a week. Day 1 will include individualized program at the fitness center, Day 2 will include a group class exercises ending with mindfulness activities, action planning and education. Day 3 will consist of an independent day when participants can attend other classes at the YMCA or repeat the fitness center. In addition, there will be 12 virtual videos of education on self-management that will be discussed during the group activity day (Day 2) .

Treatment:

Other: Back to Living Well Program

e-Health

Description:

Participants will be assessed by a LiveWell specialist to assess functional goals and baseline capacity and provide recommendation on exercise modifications and the program. LiveWell specialist may also refer participants for an assessment with a physiotherapist based on a pre-defined criteria including redflag for serious conditions. Participants will engage in a 12-week program consisting of 45 minute sessions 3 times a week. They will be provided with 3 exercise videos (including 3 levels of exercises per video) and will also have access to the on-demand YMCA platform for additional videos. In addition, there will be 12 virtual videos of education on self-management that will be discussed during follow-up phone calls. Participants will also be provided with an action planning document to complete at home. All online participants will have a phone call with the LiveWell specialist at 3 and 7 weeks to discuss the program, action planning and the education materials.

Treatment:

Other: Back to Living Well Program