Low Back Pain Clinical Trial
— Back2LiveWelOfficial title:
Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial
Verified date | February 2020 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion criteria: 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 Exclusion criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Canada | YMCA Hamilton | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Macquarie University, Australia, Universidade Federal do Ceara, University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
12 months | |
Secondary | 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 |
3 and 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Health related Quality of Life: EQ-5D-5L | EQ-5D-5L | 3, 6, 12 months (0-100) | |
Secondary | Physical activity questionnaire | IPAQ_short form | 3, 6, 12 months | |
Secondary | Physical activity level | Activity level measured using Garmin physical activity monitor | 3, 6, 12 months |
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