Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

Not Applicable

Completed

• Conditions: Low Back Pain, Recurrent; Low Back Pain
• Interventions: Other: Physical activity program; Other: Control group standard care

• Registration Number: NCT03328689
• Lead Sponsor: McMaster University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-11-01
• Study Start: 2018-11-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity in the community	Physical activity program	The physical activity program will include an individualized exercise program delivered in community exercise facility plus education..
Control group standard care	Control group standard care	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.

Primary Outcome Measures

Name	Time	Method
Activity limiting flare-up	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

Secondary Outcome Measures

Name	Time	Method
Activity limiting flare-up	3 and 6 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
Personal Impact of low back pain	3, 6, 12 months	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	3, 6, 12 months	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	3, 6, 12 months	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	3, 6, 12 months	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	3, 6, 12 months (0-100)	EQ-5D-5L
Physical activity questionnaire	3, 6, 12 months	IPAQ_short form
Physical activity level	3, 6, 12 months	Activity level measured using Garmin physical activity monitor

Trial Locations

Locations (1)

YMCA Hamilton; 🇨🇦 Hamilton, Ontario, Canada