Quebec Low Back Pain Study: Core Dataset

NCT04791891 | Recruiting

• 1 other identifier: A06-M22-18A
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Acute; Chronic; Persistence; Inception cohort; Two-stage sampling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Work status: number of participants on sick leave

  6 months

• Functional limitations: level of function

  6 months

• Health-related quality of life: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) score

  6 months

• Global impression of change of participants' conditions

  6 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female, Male, Other
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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?

Sponsors & Collaborators

• Laval University: lead
• Quebec Pain Research Network: collaborator
• Réseau provincial de recherche en adaptation réadaptation: collaborator

Study Sites (1)

McGill University

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jean-Sebastien Roy, PhD, PT

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Sebastien Roy, PhD, PT

CONTACT

1-418-529-9141; jean-sebastien.roy@fmed.ulaval.ca

Hugo Massé-Alarie, PhD, PT

CONTACT

1-418-529-9141; hugo.masse-alarie@fmed.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 10, 2021
• Study Start: November 1, 2018
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2022

Record last verified: 2021-03

Locations

CA (1)