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

NCT ID: NCT05929846

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Low Back Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

In-Person

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) .

Back to Living Well Program

Intervention Type: OTHER

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. The 12-week program will engage participants in weekly exercise sessions, education and self management sessions, and encourage independent exercise at least 1x per week. All participants will be encouraged to complete an action plan and watch online education videos weekly.

e-Health

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.

Back to Living Well Program

Intervention Type: OTHER

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. The 12-week program will engage participants in weekly exercise sessions, education and self management sessions, and encourage independent exercise at least 1x per week. All participants will be encouraged to complete an action plan and watch online education videos weekly.

Interventions

Back to Living Well Program

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. The 12-week program will engage participants in weekly exercise sessions, education and self management sessions, and encourage independent exercise at least 1x per week. All participants will be encouraged to complete an action plan and watch online education videos weekly.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Luciana Macedo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana Macedo, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Julie Richardson, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Joy MacDermid, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Mark Hancock, PhD

Role: PRINCIPAL_INVESTIGATOR

Macquarie University

Michele Crites Battie

Role: PRINCIPAL_INVESTIGATOR

Western University

Bruno Saragiotto, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de Sao Paulo

Jill Hayden, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Alison Rushton, EdD

Role: PRINCIPAL_INVESTIGATOR

Western University

Tara Packham, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Steven Bray, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Meridith Griffin, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Diego Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stephanie Di Pelino, MPH

Role: CONTACT

dipelins@mcmaster.ca

9055259140 ext. 23811

Facility Contacts

Luciana Macedo, PhD

Role: primary

References

Macedo L, Di Pelino S, Santos VS, Richardson J, MacDermid J, Hancock M, Battie MC, Saragiotto BT, Hayden JA, Rushton A, Packham T, Freman M, Bray S, Griffin M, Hladysh G, Miller P, Attwell S. Implementation of back to living well, a community-based program for the tertiary prevention of low back pain: a study protocol. BMC Musculoskelet Disord. 2024 Jul 27;25(1):593. doi: 10.1186/s12891-024-07712-7.

Reference Type: DERIVED

PMID: 39068385 (View on PubMed)

Other Identifiers

15354

Identifier Type: -

Identifier Source: org_study_id