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Back2LiveWell: Community Based Prevention of Back Pain Flare-ups (Back2LiveWel)

Primary Purpose

Low Back Pain, Recurrent, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical activity program
Control group standard care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain, Recurrent focused on measuring prevention, exercise, randomized controlled trial, physical activity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • YMCA Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical activity in the community

Control group standard care

Arm Description

The physical activity program will include an individualized exercise program delivered in community exercise facility plus education..

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
Health related Quality of Life: EQ-5D-5L
EQ-5D-5L
Physical activity questionnaire
IPAQ_short form
Physical activity level
Activity level measured using Garmin physical activity monitor

Full Information

First Posted
October 23, 2017
Last Updated
February 20, 2020
Sponsor
McMaster University
Collaborators
Macquarie University, Australia, University of Alberta, Universidade Federal do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT03328689
Brief Title
Back2LiveWell: Community Based Prevention of Back Pain Flare-ups
Acronym
Back2LiveWel
Official Title
Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 25, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Macquarie University, Australia, University of Alberta, Universidade Federal do Ceara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent, Low Back Pain
Keywords
prevention, exercise, randomized controlled trial, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity in the community
Arm Type
Experimental
Arm Description
The physical activity program will include an individualized exercise program delivered in community exercise facility plus education..
Arm Title
Control group standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical activity program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group standard care
Intervention Description
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
Primary Outcome Measure Information:
Title
Activity limiting flare-up
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Activity limiting flare-up
Description
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
Time Frame
3 and 6 months
Title
Personal Impact of low back pain
Description
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
Time Frame
3, 6, 12 months
Title
Pain intensity _NRS pain
Description
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
Time Frame
3, 6, 12 months
Title
Disability
Description
Roland Morris Disability Questionnaire is a scale from 0-24 assessing pain related disability where 0 is no disability and 24 is significant disability
Time Frame
3, 6, 12 months
Title
Function
Description
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
Time Frame
3, 6, 12 months
Title
Health related Quality of Life: EQ-5D-5L
Description
EQ-5D-5L
Time Frame
3, 6, 12 months (0-100)
Title
Physical activity questionnaire
Description
IPAQ_short form
Time Frame
3, 6, 12 months
Title
Physical activity level
Description
Activity level measured using Garmin physical activity monitor
Time Frame
3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana Macedo, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
YMCA Hamilton
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34167584
Citation
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.
Results Reference
derived

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Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

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