Clinical trial NCT04791891: Quebec Low Back Pain Study: Core Dataset
Official title: The Quebec Low Back Pain Study (QLBPS): A Platform for the Continuous Enrolment and Longitudinal Epidemiological Evaluation of Individuals With LBP.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Keywords: Acute
Chronic
Persistence
Inception cohort
Two-stage sampling
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Quebec Pain Research Network
name: Réseau provincial de recherche en adaptation réadaptation
First posted: 2021-03-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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?

Exclusion Criteria:

- No exclusion criteria

Primary outcomes:
measure: Chronicity: Number of participants who transition from acute to chronic LBP
timeFrame: 6 months
Secondary outcomes:
measure: Work status: number of participants on sick leave
timeFrame: 6 months
measure: Functional limitations: level of function
timeFrame: 6 months
measure: Health-related quality of life: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) score
timeFrame: 6 months
measure: Global impression of change of participants' conditions
timeFrame: 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Laval University
name: Jean-Sebastien Roy, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: