- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923308
The Effect of Chiropractor-informed Triage on Low Back Pain Patient Outcomes and Trajectories
March 24, 2025 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
The Effect of Chiropractor-informed Triage Versus Usual Medical Management on Low Back Pain Patient Outcomes and Trajectories in Tertiary Care Settings: a Controlled Clinical Study.
Almost everyone will have low back pain (LBP) at some point in their lives.
LBP is a complex multifactorial condition for which diagnosis and clinical management remains a challenge.
Factors such as wait times, delays in diagnosis or proper referral can result in Canadian patients having difficulty getting the care that they need.
The overall objective of this project is to explore how chiropractors, who specialize in the diagnosis and clinical management of spinal conditions, can transform healthcare trajectories and improve the health of patients with LBP by integrating medical specialist team.To do so, patients with low back pain seeking medical care within the public health system will be first seen by chiropractors.
Chiropractors will play a key role in identifying the type of low back pain and subsequently offering guidance to medical specialists with regard to the best treatment and management options that are currently recommended.
Participating patients will be followed over a year while extensive health-related data will be collected and compared to non-triage patients with LBP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
118
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Trois-Rivieres, Quebec, Canada, G9A 5H7
- Universite du Quebec à Trois-Rivieres
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This study will involve individuals seeking medical consultation in the tertiary care public health system for an episode of LBP.
The study will be conducted at the neurosurgery outpatient clinic affiliated to the Centre Intégré Universitaire de Santé et de Services Sociaux- Mauricie Centre du Québec (CIUSSS-MCQ; Trois-Rivières' regional healthcare organization).
The CIUSSS-MCQ, established in 2015 as a result of the merger of 12 health and social services public institutions, totals 974 physicians, including 515 GPs.
It serves a population of over 510,000 inhabitants, of which 83% are over 18 years of age (17).
Description
Inclusion Criteria:
- Being ≥ 18 years of age
- Being scheduled in the outpatient clinics with a primary complaint of LBP (either acute, chronic or recurring episodes), consistent with LBP definition (pain between the lower rib margins and the buttock creases, with or without associated symptoms in the lower limb(s)).
- Being able to comprehend and express oneself in French
Exclusion Criteria:
- Patients involved in litigation related to their LBP condition (i.e., worker's compensation, public automobile insurance plan or other litigations)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
|
Following the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will not be communicated to the specialist.
|
|
Intervention group
|
Following the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will be communicated to the specialist using a standardized clinical note, prior to the patient's consultation and without further discussion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in back and leg pain intensity (current and past week)
Time Frame: baseline, week 1, week 12, week 24 and 12 months follow-up
|
11-point numerical rating scale (NRS) :global measure of pain intensity anchored by two extremes of pain intensity ranging from 0 ('no pain') to 10 ('pain as bad as it could be').
|
baseline, week 1, week 12, week 24 and 12 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis made by the specialist
Time Frame: up to 4 weeks post-baseline assessment
|
The diagnosis and clinical management (i.e.
self-management; including advice or brief intervention/medication), referral to other first line care practitioner (chiropractor, physiotherapist, etc.) or medical specialist, injection, leave of absence, etc.) decided by the specialist will be retrieved immediately after the initial encounter and compared to the chiropractor's working diagnosis, risk stratification or referral need according to current evidenced-bases practice guidelines
|
up to 4 weeks post-baseline assessment
|
|
Number of requests for medical imaging
Time Frame: over a one year period
|
Will be monitored through the patient's electronic clinical record (ECR), which is used in all health and social services across the Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS-MCQ) institutions.
|
over a one year period
|
|
Number of requests for laboratory tests
Time Frame: over a one year period
|
Will be monitored through the patient's electronic clinical record (ECR), which is used in all health and social services across the CIUSSS-MCQ institutions.
|
over a one year period
|
|
Number of requests for medication prescriptions
Time Frame: over a one year period
|
Will be monitored through the patient's electronic clinical record (ECR), which is used in all health and social services across the CIUSSS-MCQ institutions.
|
over a one year period
|
|
Number of subsequent visits to the outpatient clinic or medical specialist
Time Frame: over a one year period
|
Will be monitored (including date of visit, type of professional, number of visit, prescribe medication, referrals) through the patient's electronic clinical record (ECR), which is used in all health and social services across the CIUSSS-MCQ institutions.
|
over a one year period
|
|
Number of visit to non-publicity funded care
Time Frame: over a one year period
|
Non-publicity funded care include any care that was fully paid out of pocket or reimbursed by a personal insurance coverage.
This will be tracked by asking patients at follow-up if they sought first line care for their current LBP episode since the last assessment time point.
|
over a one year period
|
|
Disability
Time Frame: baseline, week 1, week 12, week 24 and 12 months follow-up
|
Oswestry Disability Index (ODI): regroups ten questions related to different domains including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling.
Each question is rated on a scale of 0 to 5 points with a maximum score of 50.
Higher scores indicate greater disability
|
baseline, week 1, week 12, week 24 and 12 months follow-up
|
|
Number of significant pain episodes of LBP
Time Frame: over a one year period
|
Defined as LBP episode lasting more than 24 h, preceded and separated by a period of at least 1 month without LBP; will be tracked with a personal diary.
|
over a one year period
|
|
Change from baseline Health-related quality of life
Time Frame: baseline, week 1, week 12, week 24 and 12 months follow-up
|
WHO Quality of Life-BREF questionnaire: assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
The instrument comprises 26 items, which measure the following four domains: physical health, psychological health, social relationships, and environment.
Higher scores denote higher quality of life
|
baseline, week 1, week 12, week 24 and 12 months follow-up
|
|
General expectations of recovery
Time Frame: baseline
|
11-point NRS for which the patients will be asked the following question: How likely do you think it is that you will have a complete recovery?
Possible answers ranging from -5= "very unlikely" to +5="very likely", with 0 being "I don't know''
|
baseline
|
|
Perceived Global Rating of Change
Time Frame: week 1, week 12, week 24 and 12 months follow-up
|
Will be measured using the following question: With respect to your low back pain, how would you describe yourself now compared to the initial onset of symptoms?
Participants will select between one of the seven following choices: 1) completely better; 2) much improved; 3) slightly improved; 4) no change; 5) slightly worse; 6) much worse and 7) worse than ever
|
week 1, week 12, week 24 and 12 months follow-up
|
|
Patient satisfaction
Time Frame: After the baseline assessment
|
Patients will be asked to rate their experience with the chiropractor on a 5-point Likert scale (0=poor to 5=excellent) for each of the following items: 5-Time spent with the healthcare professional you saw; 6-Explanation of what was done for you; 7-Technical skills (thoroughness, carefulness, competence) of the healthcare professional you saw; 8-The personal (courtesy, respect, sensitivity, friendliness) of the person you saw; 9-The visit overall.
|
After the baseline assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2021
Primary Completion (Actual)
November 27, 2024
Study Completion (Actual)
November 27, 2024
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
June 8, 2021
First Posted (Actual)
June 11, 2021
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQTR-2021-triage
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.