Quebec Low Back Pain Study: Core Dataset (QLBPS)

January 28, 2022 updated by: Laval University

The Quebec Low Back Pain Study (QLBPS): A Platform for the Continuous Enrolment and Longitudinal Epidemiological Evaluation of Individuals With LBP.

Persistent back pain is the leading cause of years lived with disability worldwide. Current therapeutic interventions are often either not effective or are associated with undesired consequences. These concerns are further amplified by the current opioid epidemic, resulting in an enormous public health crisis. Experts from diverse disciplines including molecular/cellular biology, neuroscience, psychology and public health formed the Quebec Back Pain Consortium to address this challenge. The overall goal of this project is to facilitate research on factors that contribute to the persistence and recovery from back pain. To accomplish this goal, we will recruit individuals suffering from acute and chronic low back pain across the province of Quebec and follow their pain trajectories over two years using an online platform. During that period, satellite projects will investigate specific risk factors including genetics, diet and physical activity, and advanced statistical methods will be used to integrate and interpret the data. A better understanding of factors influencing back pain will eventually allow for improved early intervention, interruption and prevention.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Introduction The neurobiological mechanisms underlying recovery from or persistence of low back pain (LBP) remain misunderstood, limiting progress towards effective management.

We have developed an innovative two-tier design to study the transition from acute to chronic LBP. The objective of the first tier is to create a provincial web-based infrastructure to recruit and monitor the trajectory of individuals with acute LBP. The objective of the second tier is to fuel hypothesis-driven satellite data collection centers with specialized expertise to study the role of biomechanical, epigenetic, genetic, neuroanatomical, ontological, physiological, psychological, and socioeconomic factors in LBP chronicity.

Methods Adults with acute and chronic LBP will be recruited through networks, media and health care settings. A web-based interface will be used to collect self-reported variables at baseline and at 3, 6, 12 and 24 months. Acute LBP will be defined according to the Dionne 2008 consensus, while chronic LBP will be defined according to Deyo 2014. Measurements will include the Canadian minimum dataset for chronic low back pain research, DN4 for neuropathic pain, comorbidities, EQ-5D-5L for quality of life, and linkage with provincial medico-administrative databases. The primary outcome will be the transition to chronic LBP for the adults with acute LBP at baseline. Secondary outcomes (for both adults with acute and chronic LBP at baseline) include healthcare resource utilization, disability, sick leave, mood, and quality of life. This study brings together diverse research expertise to investigate the transition from acute to chronic LBP, characterize the progression to recovery or chronicity, and identify patterns associated with that progression.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The QLBPS will enroll adult women and men with self-reported LBP. The proposed cohort study will be population-based including individuals from urban, remote and rural areas and will not be restricted to patients consulting healthcare professionals substantially improving the generalisability of the results. Potential participants have to be at least 18 years, have internet or phone access, be fluent in either French or English, and have self-reported acute low back pain.

Description

Inclusion Criteria:

  • At least 18 years old;
  • Internet access;
  • Fluent in English or French;
  • Self-reported LBP. Presence of LBP will be based on the recommendations of the Standardized Delphi Definitions of Low Back Pain Prevalence. According to these recommendations, LBP is present if both the following questions are answered "yes": (1) In the past 4 weeks, have you had pain in your low back? (2) If yes, was this pain bad enough to limit your usual activities or change your daily routine for more than one day?

Exclusion Criteria:

- No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Low Back Pain (LBP)

Adult women and men with self-reported LBP.

Inclusion Criteria for potential LBP participants

  • At least 18 years old;
  • Internet access;
  • Fluent in English or French;
  • Self-reported LBP.

Exclusion Criteria: No exclusion criteria will be adopted in this study.

  • No exclusion criteria will be adopted in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronicity: Number of participants who transition from acute to chronic LBP
Time Frame: 6 months
Chronic LBP will be defined based on the NIH task force recommendations which define chronic LBP as an ongoing problem for at least 3 months and that has resulted in a problem on at least half of the days in the past 6 months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work status: number of participants on sick leave
Time Frame: 6 months
As measured by the self-reported core dataset questionnaire, which includes 2 questions on LBP-related workplace absenteeism and benefits.
6 months
Functional limitations: level of function
Time Frame: 6 months
As measured by the self reported core dataset questionnaire, which includes 4 questions on functional limitations from the Patient-Reported Outcomes Measurement Information System (PROMIS). The level of function is measured on a scale of ''without any difficulty/with little difficulty/ with some difficulty/with much difficulty/'unable to do''. A higher score indicates better outcome.
6 months
Health-related quality of life: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) score
Time Frame: 6 months
The EQ-5D-5L score measures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) scored on five levels (no, slight, moderate, severe, extreme problems/unable to). A higher score indicates worse outcome (min = 5, max = 25).
6 months
Global impression of change of participants' conditions
Time Frame: 6 months
As measured by the self-reported core dataset questionnaire. Participants rate the extent to which they feel their condition has changed in terms of pain symptoms, functioning and quality of life, in the past 3 months, using a 7-point Likert scale Patient Global Impression of Change (PGIC) (no change / almost the same / a little better / somewhat better / moderately better / better / a great deal better). A higher score indicates a better outcome.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Réseau provincial de recherche en adaptation réadaptation
Quebec Pain Research Network

Investigators

  • Principal Investigator: Jean-Sebastien Roy, PhD, PT, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A06-M22-18A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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