Quebec Low Back Pain Study: Core Dataset

Low Back Pain Clinical Trial

— QLBPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791891
• Other study ID #: A06-M22-18A
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2021
• Source: Laval University
• Contact: Jean-Sebastien Roy, PhD, PT
• Phone: 1-418-529-9141
• Email: jean-sebastien.roy[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Canada	McGill University	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Quebec Pain Research Network, Réseau provincial de recherche en adaptation réadaptation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronicity: Number of participants who transition from acute to chronic LBP	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	Work status: number of participants on sick leave	As measured by the self-reported core dataset questionnaire, which includes 2 questions on LBP-related workplace absenteeism and benefits.	6 months
Secondary	Functional limitations: level of function	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
Secondary	Health-related quality of life: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) score	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
Secondary	Global impression of change of participants' conditions	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