Back to Living Well: Implementation of a Community-based Program for Low Back Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Identify program barriers and facilitators from the perspective of the patients,
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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,
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Identify factors influencing participants to select an in-person or e-health program,
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Evaluation program specific implementation barriers and facilitators from the perspectives of the organization and care delivery perspectives.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) . |
Other: 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 independet exercise at least 1x per week. All participants will be encouraged to complete an action plan and watch online education videos weekly.
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| 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. |
Other: 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 independet exercise at least 1x per week. All participants will be encouraged to complete an action plan and watch online education videos weekly.
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Outcome Measures
Primary Outcome Measures
- Roland Morris Disability Questionnaire [12-months]
RMDQ is for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. The score ranges from 0 (no disability) to 24 (maximum disability)
Secondary Outcome Measures
- Pain NRS [Baseline, 3, 6 & 12 months]
Average pain over the last week on a scale of 0 (no pain) to 10 (extreme pain)
- Self Report Flare [Once a week for 12 months (week 0-week 52)]
Participants will meet the criteria for activity-limiting flare if pain has increased at least 2 points on a NRS- 10 point scale (MCID) over the previous week
- Activity Limitation [Once a week for 12 months (week 0-week 52)]
Scale from 1-5 about the level in which pain interfered with day to day activities
- EQ-5D-5L [Once a week for 12 months (week 0-week 52)]
Anxiety and Depression dimensions only. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
- TAMPA Scale of Kinesiophobia [Baseline, 3, 6 & 12 months]
a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
- Pain Self-Efficacy Questionnaire [Baseline, 3, 6 & 12 months]
10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain.
- Coping Strategies Questionnaire [Baseline, 3, 6 & 12 months]
5 item scale to measure ability to cope with pain.
- Pain Catastrophizing [Baseline, 3, 6 & 12 months]
13-item self report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.
- EQ-5D-5L [Baseline, 3, 6 & 12 months]
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
- IPAQ [Baseline, 3, 6 & 12 months]
27-item self-reported measure of physical activity for use with individual adult patients
- Patient Specific Functional Scale [Baseline, 3, 6 & 12 months]
The PSFS is a self-reported valid, reliable, and responsive outcome measure for patients with back, neck, knee and upper extremity problems.
- PROMIS IMPACT [Baseline, 3, 6 & 12 months]
An adapted version of this survey will collect data on back pain.
- Treatment Self Regulation Questionnaire [Baseline, 3, 6 & 12 months]
This self-reported questionnaire assesses the degree to which a person's motivation for the health behaviors
- Center for Epidemiologic Studies Depression Scale [Baseline, 3, 6 & 12 months]
A 20-item measure self reported scale to measure depressive symptoms. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
- Exercise Adherence Rating Scale [3, 6 & 12 months]
A 6-item questionnaire aimed at measuring adherence behavior and exploring reasons for nonadherence
- Adherence exercise [3 months]
Number of exercise session attended or exercise videos watched as per online program
- Adherence education [3 months]
Number of virtual education videos watched
- Roland Morris Disability Questionnaire [baseline, 3 and 6 months.]
RMDQ to assess pain related disability in low back pain. 0 is no disbility 24 is max disability.
Other Outcome Measures
- Long term physical activity [12 months]
Length of YMCA membership
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Have non-specific LBP
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History of persistent LBP for 3 or more months that is mild, moderate, or severe
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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.
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18 years old or older
Exclusion Criteria:
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Co-morbidity preventing participation in exercise based on screening using the Physical Activity Readiness Questionnaire and later not cleared by their family physician
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Inadequate English to complete questionnaires and interviews
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Participants who are currently seeking care for LBP
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McMaster University | Hamilton | Ontario | Canada | L8S 1C7 |
Sponsors and Collaborators
- McMaster University
Investigators
- Principal Investigator: Luciana Macedo, PhD, McMaster University
- Principal Investigator: Julie Richardson, PhD, McMaster University
- Principal Investigator: Joy MacDermid, PhD, McMaster University
- Principal Investigator: Mark Hancock, PhD, Macquarie University
- Principal Investigator: Michele Crites Battie, Western University
- Principal Investigator: Bruno Saragiotto, PhD, Universidade Cidade de Sao Paulo
- Principal Investigator: Jill Hayden, PhD, Dalhousie University
- Principal Investigator: Alison Rushton, EdD, Western University
- Principal Investigator: Tara Packham, PhD, McMaster University
- Principal Investigator: Steven Bray, PhD, McMaster University
- Principal Investigator: Meridith Griffin, PhD, McMaster University
- Principal Investigator: Diego Silva, PhD, McMaster University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15354