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| Name | Class |
|---|---|
| Macquarie University, Australia | OTHER |
| University of Alberta | OTHER |
| Universidade Federal do Ceara | OTHER |
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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.
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:
Exploratory objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity in the community | Experimental | The physical activity program will include an individualized exercise program delivered in community exercise facility plus education.. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Activity limiting flare-up |
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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Activity limiting flare-up |
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 |
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Inclusion criteria:
Participants will be included if they meet the following criteria
Exclusion criteria:
Participants will be excluded if they meet the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciana Macedo, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YMCA Hamilton | Hamilton | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34167584 | Derived | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Given that this is an exercise study blinding of participants and those delivering the exercise program will not be possible. Outcome measures will be collected by an investigator not aware of treatment allocation, but most outcome measures will be self-reported and thus, true assessor blinding will no be possible. All statistical analysis will be conducted by a blinded investigator.
|
| Control group standard care | Other | 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 |
|
| 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 | 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 | 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 | 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 | 3, 6, 12 months |
| Health related Quality of Life: EQ-5D-5L | EQ-5D-5L | 3, 6, 12 months (0-100) |
| Physical activity questionnaire | IPAQ_short form | 3, 6, 12 months |
| Physical activity level | Activity level measured using Garmin physical activity monitor | 3, 6, 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |