Low Back PainQLBPSNCT04791891
Quebec Low Back Pain Study: Core Dataset
An observational study of Low Back Pain, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- How many people
- 10,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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?
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec
Iulia Tufa, BSc, 1-844-494-8376, iulia.tufa@mail.mcgill.ca
About this study
Official 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.
Read the 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
- Keywords
- Acute, Chronic, Persistence, Inception cohort, Two-stage sampling
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Nov 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Pain Research Network, Réseau provincial de recherche en adaptation réadaptation
- Responsible party
- Sponsor
- Investigators
- Jean-Sebastien Roy, PhD, PT, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791891
- Sponsor's protocol ID
- A06-M22-18A
- Acronym
- QLBPS
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quebec Low Back Pain Study (QLBPS): A Platform for the Continuous Enrolment and Longitudinal Epidemiological Evaluation of Individuals With LBP.
- ClinicalTrials.gov ID
- NCT04791891
- Acronym / sponsor ID
- QLBPS / A06-M22-18A
- Conditions
- Low Back Pain
- Keywords
- Acute, Chronic, Persistence, Inception cohort, Two-stage sampling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Quebec Pain Research Network, Réseau provincial de recherche en adaptation réadaptation
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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?
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronicity: Number of participants who transition from acute to chronic LBP
Time frame: 6 months
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.
4 secondary outcomes
Work status: number of participants on sick leave
Time frame: 6 months
Functional limitations: level of function
Time frame: 6 months
Health-related quality of life: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) score
Time frame: 6 months
Global impression of change of participants' conditions
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Sebastien Roy, PhD, PT principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Sebastien Roy, PhD, PT (1-418-529-9141 ext. 6005, jean-sebastien.roy@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronicity: Number of participants who transition from acute to chronic LBP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.