Clinical trial NCT05929846: Back to Living Well: Implementation of a Community-based Program for Low Back Pain
Official title: Back to Living Well: Implementation of a Community-based Program for the Secondary and Tertiary Prevention of Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be individuals from the community suffering from LBP. We will recruit participants that have demonstrated interested on the Back to Living Well program and have reached out to the YMCA to learn more about the program and to register. Participants will be referred to the study by the YMCA at the time that they decide to enroll in the program in one of the YMCA available locations ( YMCA location in Downtown Hamilton, Les Chater, Ron Edwards, Laurier Brantford or Flamborough ) .

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.

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

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: 12-months
Secondary outcomes:
measure: Pain NRS
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Self Report Flare
timeFrame: Once a week for 12 months (week 0-week 52)
measure: Activity Limitation
timeFrame: Once a week for 12 months (week 0-week 52)
measure: EQ-5D-5L
timeFrame: Once a week for 12 months (week 0-week 52)
measure: TAMPA Scale of Kinesiophobia
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Pain Self-Efficacy Questionnaire
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Coping Strategies Questionnaire
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: EQ-5D-5L
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: International Physical Activity Questionnaires
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Patient Specific Functional Scale
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: PROMIS IMPACT
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Treatment Self Regulation Questionnaire
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Exercise Adherence Rating Scale
timeFrame: Baseline, 3 months, 6 months & 12 months
measure: Adherence exercise
timeFrame: After completion of the program (3 months)
measure: Adherence education
timeFrame: After completion of the program (3 months)
Other outcomes:
measure: Long term physical activity
timeFrame: 12 months after baseline
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Luciana Macedo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Julie Richardson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Joy MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Macquarie University
name: Mark Hancock, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University
name: Michele Crites Battie
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Cidade de Sao Paulo
name: Bruno Saragiotto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Jill Hayden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University
name: Alison Rushton, EdD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Tara Packham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Steven Bray, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Meridith Griffin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Diego Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: