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

Low Back Pain Clinical Trial

Official title: Back to Living Well: Implementation of a Community-based Program for the Secondary and Tertiary Prevention of Low Back Pain

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

• NCT number: NCT05929846
• Study type: Observational
• Source: McMaster University
• Contact: Stephanie Di Pelino, MPH
• Phone: 9055259140
• Email: dipelins@mcmaster.ca
• Status: Recruiting
• Start date: June 10, 2023
• Completion date: December 31, 2025