Low Back Pain Clinical Trial
— QLBPSOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Quebec Pain Research Network, Réseau provincial de recherche en adaptation réadaptation |
Canada,
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 |
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