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Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

NCT03328689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-02-21

No results posted yet for this study

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.

Conditions

  • Low Back Pain, Recurrent
  • Low Back Pain

Interventions

OTHER

Physical activity program

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.

OTHER

Control group standard care

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

Sponsors & Collaborators

  • Macquarie University, Australia

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Universidade Federal do Ceara

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Luciana Macedo, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-25
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03328689 on ClinicalTrials.gov