Quebec Low Back Pain Study: Core Dataset

NCT ID: NCT04791891

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Low Back Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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?

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quebec Pain Research Network

OTHER

Sponsor Role: collaborator

Réseau provincial de recherche en adaptation réadaptation

UNKNOWN

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Sebastien Roy, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

McGill University

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jean-Sebastien Roy, PhD, PT

Role: CONTACT

jean-sebastien.roy@fmed.ulaval.ca

1-418-529-9141 ext. 6005

Hugo Massé-Alarie, PhD, PT

Role: CONTACT

hugo.masse-alarie@fmed.ulaval.ca

1-418-529-9141 ext. 6642

Facility Contacts

Iulia Tufa, BSc

Role: primary

iulia.tufa@mail.mcgill.ca

1-844-494-8376

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

A06-M22-18A

Identifier Type: -

Identifier Source: org_study_id