Low Back Pain, RecurrentBack2LiveWelNCT03328689
Back2LiveWell: Community Based Prevention of Back Pain Flare-ups
A study testing Physical activity program in people with Low Back Pain, Recurrent and Low Back Pain, run by McMaster University at 1 site in Canada.
Trial summary
The primary objective of this study is to compare the effectiveness and cost-effectiveness of an individualized group based exercise and education program supported in the community to a control group of usual care in preventing back pain flare-ups and to mitigate the negative consequences of subsequent episodes if… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Recurrent, Low Back Pain
- What is being tested?
- Physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be included if they meet the following criteria
- Have been discharged <3 months from physiotherapy, chiropractic or osteopathic care following a course of treatment for LBP (pain in the area between the 12th rib and buttock crease)
- Have non-specific LBP which is pain not attributed to a specific diagnosis such as sciatica, ankylosing spondylitis, vertebral fracture, etc.
- Non-specific LBP sometimes called mechanical LBP accounts for ~85% of LBP diagnosis.
- Between 18 and 80 years of age
Who cannot join
- Participants will be excluded if they meet the following criteria:
- Ongoing high pain intensity, defined as pain intensity of 6 or more on a 0-10 point scale. The cut off of 6/10 is used in the literature to dichotomise low/moderate to high pain intensity.
- Co-morbidity preventing participation in physical activity evaluated using the Physical Activity Readiness Questionnaire (PAR-Q) from the American College of Sports Medicine guidelines
- Inadequate English to complete outcome measures
- Currently participating in an exercise program similar to the one we will evaluate.
- History of spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial
The primary objective of this study is to compare the effectiveness and cost-effectiveness of an individualized group based exercise and education program supported in the community to a control group of usual care in preventing back pain flare-ups and to mitigate the negative consequences of subsequent episodes if they occur.
Read the detailed description
Secondary objectives are to:
- To compare the effectiveness of the two interventions in preventing an activity-limiting LBP flare up at 12 and 24 months.
Secondary objectives are to:
- To compare the effectiveness of the interventions in mitigating the negative consequences of LBP.
- To evaluate the cost-effectiveness of the interventions in preventing activity-limiting LBP flare-up.
- To identify subgroups of individuals that may best respond to each one of the two interventions.
Exploratory objectives include:
- evaluate the fluctuating nature of back pain using a smart phone application to collect pain measures once a week for 1 year (trajectories will also be evaluated to compare between group effects)
- assess adherence to physical activity using activity monitors.
- evaluate the relationship between activity levels and flare-ups as a method for understanding pain triggers and impact of activity pacing.
- Conditions
- Low Back Pain, Recurrent, Low Back Pain
- Being tested
- Physical activity program, Control group standard care
- Keywords
- prevention, exercise, randomized controlled trial, physical activity
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programOther
This arm will begin with PT assessment. Following this, participants will meet with a specialist who will design an individualized physical activity program. Classes will include warm up, 40 minutes of individualized exercises and a cool down that will include back pain specific exercises including core strengthening. The first 4 weeks of exercise will include a 30-minute education program. Education comprise information on back pain, efficient use of the back during daily activities, self-management, self-efficacy and pain neurophysiology. Classes will run for a 12-week period. Participants will be encouraged to attend the exercise facility at least 3 times a week. An activity monitor will be provided to all participants. We will use group classes to facilitate the development of social support.
Control group standard careOther
Participants from the control group will receive usual care which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity.
Participants in the control group will also receive and activity monitor for collection of physical activity data. This activity monitor may also be used for positive feedback and activity reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Physical activity in the community | Experimental | The physical activity program will include an individualized exercise program delivered in community exercise facility plus education.. Receives: Other: Physical activity program |
| Control group standard care | Active comparator | Participants from the control group will receive no additional intervention other than being encouraged to continue with their physiotherapists or chiropractor recommendation which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity. Receives: Other: Control group standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity limiting flare-up
- flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15
- activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation.
Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above.
Flare-up will be collected once a week for 1 year
Measured: 12 months
Secondary outcomes (8)
Activity limiting flare-up
- flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15
- activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation.
Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above.
Flare-up will be collected once a week for 1 year
Measured: 3 and 6 months
Personal Impact of low back pain
the outcome combines 9 items from the Patient Reported Outcome Measurement Information System (PROMIS) short form and covers the domains of pain intensity, pain interference with normal activities and functional status widely recommended in consensus documents on outcome measures for back pain
Measured: 3, 6, 12 months
Pain intensity _NRS pain
Pain intensity over the last week will be measured using a numeric rating scale 0-10 where 0 is not pain and 10 is worse pain
Measured: 3, 6, 12 months
Disability
Roland Morris Disability Questionnaire is a scale from 0-24 assessing pain related disability where 0 is no disability and 24 is significant disability
Measured: 3, 6, 12 months
Function
Patient Specific Functional Scale is a self reported scale assessing function on a scale from 0-10 where 0 is not able to perform the activity and 10 is able without pain
Measured: 3, 6, 12 months
Health related Quality of Life: EQ-5D-5L
EQ-5D-5L
Measured: 3, 6, 12 months (0-100)
Physical activity questionnaire
IPAQ_short form
Measured: 3, 6, 12 months
Physical activity level
Activity level measured using Garmin physical activity monitor
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start25 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Pain, RecurrentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Macquarie University, Australia, University of Alberta, Universidade Federal do Ceara
- Responsible party
- Principal investigator, Luciana Macedo, McMaster University
- Investigators
- Luciana Macedo, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328689
- Sponsor's protocol ID
- Back2LiveWell2017
- Acronym
- Back2LiveWel
- Status last verified
- Feb 2020
- First submitted
- 23 Oct 2017
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macedo LG, Richardson J, Battie MC, Hancock M, Kwan M, Hladysh G, Zhuo L. Back to living well: community-based management of low back pain: a feasibility study. Pilot Feasibility Stud. 2021 Jun 24;7(1):134. doi: 10.1186/s40814-021-00863-7.
PubMed 34167584
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03328689
- Acronym / sponsor ID
- Back2LiveWel / Back2LiveWell2017
- Conditions
- Low Back Pain, Recurrent, Low Back Pain
- Keywords
- prevention, exercise, randomized controlled trial, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Macquarie University, Australia, University of Alberta, Universidade Federal do Ceara
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Nov 2017 (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.
The primary objective of this study is to compare the effectiveness and cost-effectiveness of an individualized group based exercise and education program supported in the community to a control group of usual care in preventing back pain flare-ups and to mitigate the negative consequences of subsequent episodes if they occur.
Detailed description
Secondary objectives are to:
- To compare the effectiveness of the two interventions in preventing an activity-limiting LBP flare up at 12 and 24 months.
Secondary objectives are to:
- To compare the effectiveness of the interventions in mitigating the negative consequences of LBP.
- To evaluate the cost-effectiveness of the interventions in preventing activity-limiting LBP flare-up.
- To identify subgroups of individuals that may best respond to each one of the two interventions.
Exploratory objectives include:
- evaluate the fluctuating nature of back pain using a smart phone application to collect pain measures once a week for 1 year (trajectories will also be evaluated to compare between group effects)
- assess adherence to physical activity using activity monitors.
- evaluate the relationship between activity levels and flare-ups as a method for understanding pain triggers and impact of activity pacing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity in the community | Experimental | Other: Physical activity programThe physical activity program will include an individualized exercise program delivered in community exercise facility plus education.. |
| Control group standard care | Active comparator | Other: Control group standard careParticipants from the control group will receive no additional intervention other than being encouraged to continue with their physiotherapists or chiropractor recommendation which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be included if they meet the following criteria
- Have been discharged <3 months from physiotherapy, chiropractic or osteopathic care following a course of treatment for LBP (pain in the area between the 12th rib and buttock crease)
- Have non-specific LBP which is pain not attributed to a specific diagnosis such as sciatica, ankylosing spondylitis, vertebral fracture, etc.
- Non-specific LBP sometimes called mechanical LBP accounts for ~85% of LBP diagnosis.
- Between 18 and 80 years of age
Key exclusion criteria (6 listed)
- Ongoing high pain intensity, defined as pain intensity of 6 or more on a 0-10 point scale. The cut off of 6/10 is used in the literature to dichotomise low/moderate to high pain intensity.
- Co-morbidity preventing participation in physical activity evaluated using the Physical Activity Readiness Questionnaire (PAR-Q) from the American College of Sports Medicine guidelines
- Inadequate English to complete outcome measures
- Currently participating in an exercise program similar to the one we will evaluate.
- History of spine surgery
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 |
|---|---|---|
| Physical activity programThis arm will begin with PT assessment. Following this, participants will meet with a specialist who will design an individualized physical activity program. Classes will include warm up, 40 minutes of individualized exercises and a cool down that will include back pain specific exercises including core strengthening. The first 4 weeks of exercise will include a 30-minute education program. Education comprise information on back pain, efficient use of the back during daily activities, self-management, self-efficacy and pain neurophysiology. Classes will run for a 12-week period. Participants will be encouraged to attend the exercise facility at least 3 times a week. An activity monitor will be provided to all participants. We will use group classes to facilitate the development of social support. | Other | Physical activity in the community |
| Control group standard careParticipants from the control group will receive usual care which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity. Participants in the control group will also receive and activity monitor for collection of physical activity data. This activity monitor may also be used for positive feedback and activity reinforcement | Other | Control group standard care |
Primary outcome
Activity limiting flare-up
Time frame: 12 months
* flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15 * activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation. Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above. Flare-up will be collected once a week for 1 year
8 secondary outcomes
Activity limiting flare-up
Time frame: 3 and 6 months
Personal Impact of low back pain
Time frame: 3, 6, 12 months
Pain intensity _NRS pain
Time frame: 3, 6, 12 months
Disability
Time frame: 3, 6, 12 months
Function
Time frame: 3, 6, 12 months
Health related Quality of Life: EQ-5D-5L
Time frame: 3, 6, 12 months (0-100)
Physical activity questionnaire
Time frame: 3, 6, 12 months
Physical activity level
Time frame: 3, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 34167584Macedo LG, Richardson J, Battie MC, Hancock M, Kwan M, Hladysh G, Zhuo L. Back to living well: community-based management of low back pain: a feasibility study. Pilot Feasibility Stud. 2021 Jun 24;7(1):134. doi: 10.1186/s40814-021-00863-7.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Low Back Pain, Recurrent and 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 6 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: finished, as of the sponsor's last update on 21 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Activity limiting flare-up (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 NCT03328689, 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 21 Feb 2020.