Low Back PainNCT05929846
Back to Living Well: Implementation of a Community-based Program for Low Back Pain
An observational study of Low Back Pain, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Back to Living Well Program
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2023to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 ) .
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Back to Living Well: Implementation of a Community-based Program for the Secondary and Tertiary Prevention of Low Back Pain
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.
Read the 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:
- Identify program barriers and facilitators from the perspective of the patients,
- 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,
- Identify factors influencing participants to select an in-person or e-health program,
- Evaluation program specific implementation barriers and facilitators from the perspectives of the organization and care delivery perspectives.
- Conditions
- Low Back Pain
- Being tested
- Back to Living Well Program
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back to Living Well ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) . Receives: Other: Back to Living Well Program | |
| 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. Receives: Other: Back to Living Well Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12-months
Secondary outcomes (17)
Pain NRS
Average pain over the last week on a scale of 0 (no pain) to 10 (extreme pain).
Measured: Baseline, 3 months, 6 months & 12 months
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
Measured: Once a week for 12 months (week 0-week 52)
Activity Limitation
Scale from 1-5 about the level in which pain interfered with day to day activities
Measured: Once a week for 12 months (week 0-week 52)
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.
Measured: Once a week for 12 months (week 0-week 52)
TAMPA Scale of Kinesiophobia
a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
Measured: Baseline, 3 months, 6 months & 12 months
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.
Measured: Baseline, 3 months, 6 months & 12 months
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.
Measured: Baseline, 3 months, 6 months & 12 months
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.
Measured: Baseline, 3 months, 6 months & 12 months
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.
Measured: Baseline, 3 months, 6 months & 12 months
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.
Measured: Baseline, 3 months, 6 months & 12 months
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"
Measured: Baseline, 3 months, 6 months & 12 months
PROMIS IMPACT
An adapted version of this survey will collect data on back pain.
Measured: Baseline, 3 months, 6 months & 12 months
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).
Measured: Baseline, 3 months, 6 months & 12 months
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.
Measured: Baseline, 3 months, 6 months & 12 months
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).
Measured: Baseline, 3 months, 6 months & 12 months
Adherence exercise
Number of exercise session attended or exercise videos watched as per online program
Measured: After completion of the program (3 months)
Adherence education
Number of virtual education videos watched
Measured: After completion of the program (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Jun 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana Macedo, McMaster University
- Investigators
- Luciana Macedo, PhD, Principal investigator, McMaster UniversityJulie Richardson, PhD, Principal investigator, McMaster UniversityJoy MacDermid, PhD, Principal investigator, McMaster UniversityMark Hancock, PhD, Principal investigator, Macquarie UniversityMichele Crites Battie, Principal investigator, Western UniversityBruno Saragiotto, PhD, Principal investigator, Universidade Cidade de Sao PauloJill Hayden, PhD, Principal investigator, Dalhousie UniversityAlison Rushton, EdD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929846
- Sponsor's protocol ID
- 15354
- Status last verified
- Jan 2026
- First submitted
- 5 Jun 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39068385
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back to Living Well: Implementation of a Community-based Program for the Secondary and Tertiary Prevention of Low Back Pain
- ClinicalTrials.gov ID
- NCT05929846
- Acronym / sponsor ID
- 15354
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify program barriers and facilitators from the perspective of the patients,
- 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,
- Identify factors influencing participants to select an in-person or e-health program,
- Evaluation program specific implementation barriers and facilitators from the perspectives of the organization and care delivery perspectives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person | – | Other: Back to Living Well ProgramParticipants 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) . |
| e-Health | – | Other: Back to Living Well ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 ) .
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back to Living Well ProgramThe 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. | Other | In-Person, e-Health |
Primary outcome
Roland Morris Disability Questionnaire
Time frame: 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).
17 secondary outcomes
Pain NRS
Time frame: Baseline, 3 months, 6 months & 12 months
Self Report Flare
Time frame: Once a week for 12 months (week 0-week 52)
Activity Limitation
Time frame: Once a week for 12 months (week 0-week 52)
EQ-5D-5L
Time frame: Once a week for 12 months (week 0-week 52)
TAMPA Scale of Kinesiophobia
Time frame: Baseline, 3 months, 6 months & 12 months
Pain Self-Efficacy Questionnaire
Time frame: Baseline, 3 months, 6 months & 12 months
Coping Strategies Questionnaire
Time frame: Baseline, 3 months, 6 months & 12 months
Pain Catastrophizing Scale
Time frame: Baseline, 3 months, 6 months & 12 months
EQ-5D-5L
Time frame: Baseline, 3 months, 6 months & 12 months
International Physical Activity Questionnaires
Time frame: Baseline, 3 months, 6 months & 12 months
Patient Specific Functional Scale
Time frame: Baseline, 3 months, 6 months & 12 months
PROMIS IMPACT
Time frame: Baseline, 3 months, 6 months & 12 months
Treatment Self Regulation Questionnaire
Time frame: Baseline, 3 months, 6 months & 12 months
Center for Epidemiologic Studies Depression Scale
Time frame: Baseline, 3 months, 6 months & 12 months
Exercise Adherence Rating Scale
Time frame: Baseline, 3 months, 6 months & 12 months
Adherence exercise
Time frame: After completion of the program (3 months)
Adherence education
Time frame: After completion of the program (3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Derived from this study: PubMed 39068385Macedo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Macedo, PhD principal investigator
McMaster University
Julie Richardson, PhD principal investigator
McMaster University
Joy MacDermid, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Questionnaire (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.