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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929846
• Other study ID #: 15354
• Status: Recruiting
• Start date: June 10, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: McMaster University
• Contact: Stephanie Di Pelino, MPH
• Phone: 9055259140
• Email: dipelins[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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 independent exercise at least 1x per week. All participants will be encouraged to complete an action plan and watch online education videos weekly.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long term physical activity	Length of YMCA membership	12 months after baseline
Primary	Roland Morris Disability Questionnaire	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).	12-months
Secondary	Pain NRS	Average pain over the last week on a scale of 0 (no pain) to 10 (extreme pain).	Baseline, 3 months, 6 months & 12 months
Secondary	Self Report Flare	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	Once a week for 12 months (week 0-week 52)
Secondary	Activity Limitation	Scale from 1-5 about the level in which pain interfered with day to day activities	Once a week for 12 months (week 0-week 52)
Secondary	EQ-5D-5L	Anxiety and Depression dimensions only. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.; Depending on the level, a number is assigned to each dimension, so that a 5-digit number combination is obtained into a EQ5D Health State.	Once a week for 12 months (week 0-week 52)
Secondary	TAMPA Scale of Kinesiophobia	a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.	Baseline, 3 months, 6 months & 12 months
Secondary	Pain Self-Efficacy Questionnaire	10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.	Baseline, 3 months, 6 months & 12 months
Secondary	Coping Strategies Questionnaire	5 item scale to measure ability to cope with pain. Minimum score of 0 and maximum score of 36, with higher scores indicating greater use of a particular coping strategy.	Baseline, 3 months, 6 months & 12 months
Secondary	Pain Catastrophizing Scale	13-item self report measure designed to assess catastrophic thinking related to pain A total score ranges from 0-52, with higher scales representing higher pain catastrophizing for individuals with chronic pain.	Baseline, 3 months, 6 months & 12 months
Secondary	EQ-5D-5L	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.; Depending on the level, a number is assigned to each dimension, so that a 5-digit number combination is obtained into a EQ5D Health State.; The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.	Baseline, 3 months, 6 months & 12 months
Secondary	International Physical Activity Questionnaires	27-item self-reported measure of physical activity for use with individual adult patients. There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.	Baseline, 3 months, 6 months & 12 months
Secondary	Patient Specific Functional Scale	The PSFS is a self-reported valid, reliable, and responsive outcome measure for patients with back, neck, knee and upper extremity problems. Participants identify 3 important activities that you are unable to do or have difficulty performing. Patients are asked to rate (on an 11-point scale) the current level of difficulty associated with each activity. 0" represents "unable to perform" and "10" represents "able to perform at prior level"	Baseline, 3 months, 6 months & 12 months
Secondary	PROMIS IMPACT	An adapted version of this survey will collect data on back pain.	Baseline, 3 months, 6 months & 12 months
Secondary	Treatment Self Regulation Questionnaire	This self-reported questionnaire assesses the degree to which a person's motivation for the health behaviors. Likert typescale ranging from 1 (not at all true) to 7 (very true). There are three subscales to the scale: the autonomous regulatory style; the controlled regulatory style; and amotivation (which refers to being unmotivated).	Baseline, 3 months, 6 months & 12 months
Secondary	Center for Epidemiologic Studies Depression Scale	A 20-item measure self reported scale to measure depressive symptoms. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline, 3 months, 6 months & 12 months
Secondary	Exercise Adherence Rating Scale	A 6-item questionnaire aimed at measuring adherence behavior and exploring reasons for nonadherence. The six items are scored using an ordinal answer scale (0 = strongly agree to 4 = totally disagree), with higher scores indicating greater adherence (0 to 24).	Baseline, 3 months, 6 months & 12 months
Secondary	Adherence exercise	Number of exercise session attended or exercise videos watched as per online program	After completion of the program (3 months)
Secondary	Adherence education	Number of virtual education videos watched	After completion of the program (3 months)