Low Back PainNCT04923308
The Effect of Chiropractor-informed Triage on Low Back Pain Patient Outcomes and Trajectories
An observational study of Low Back Pain and Triage, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Triage
- What is being tested?
- Triage results disclosed and Triage results undisclosed
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2021to 27 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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).
Who may be able to join
- 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
Who cannot join
- Patients involved in litigation related to their LBP condition (i.e., worker's compensation, public automobile insurance plan or other litigations)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7
About this study
Official title: 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.
- Conditions
- Low Back Pain, Triage
- Being tested
- Triage results disclosed, Triage results undisclosed
- Keywords
- Low back pain, triage, care pathways, chiropractor, pain, disability, health resources
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triage results disclosedOther
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.
Triage results undisclosedOther
Following the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will not be communicated to the specialist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Not described Receives: Other: Triage results disclosed | |
| Control group | Not described Receives: Other: Triage results undisclosed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in back and leg pain intensity (current and past week)
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').
Measured: baseline, week 1, week 12, week 24 and 12 months follow-up
Secondary outcomes (12)
Diagnosis made by the specialist
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
Measured: up to 4 weeks post-baseline assessment
Number of requests for medical imaging
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.
Measured: over a one year period
Number of requests for laboratory tests
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.
Measured: over a one year period
Number of requests for medication prescriptions
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.
Measured: over a one year period
Number of subsequent visits to the outpatient clinic or medical specialist
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.
Measured: over a one year period
Number of visit to non-publicity funded care
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.
Measured: over a one year period
Disability
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
Measured: baseline, week 1, week 12, week 24 and 12 months follow-up
Number of significant pain episodes of LBP
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.
Measured: over a one year period
Change from baseline Health-related quality of life
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
Measured: baseline, week 1, week 12, week 24 and 12 months follow-up
General expectations of recovery
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''
Measured: baseline
Perceived Global Rating of Change
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
Measured: week 1, week 12, week 24 and 12 months follow-up
Patient satisfaction
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.
Measured: After the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start6 Jul 2021
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923308
- Sponsor's protocol ID
- UQTR-2021-triage
- Status last verified
- Mar 2025
- First submitted
- 2 Jun 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04923308
- Acronym / sponsor ID
- UQTR-2021-triage
- Conditions
- Low Back Pain, Triage
- Keywords
- Low back pain, triage, care pathways, chiropractor, pain, disability, health resources
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 11 Jun 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: Triage results disclosed |
| Control group | – | Other: Triage results undisclosed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients involved in litigation related to their LBP condition (i.e., worker's compensation, public automobile insurance plan or other litigations)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triage results disclosedFollowing 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. | Other | Intervention group |
| Triage results undisclosedFollowing the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will not be communicated to the specialist. | Other | Control group |
Primary outcome
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').
12 secondary outcomes
Diagnosis made by the specialist
Time frame: up to 4 weeks post-baseline assessment
Number of requests for medical imaging
Time frame: over a one year period
Number of requests for laboratory tests
Time frame: over a one year period
Number of requests for medication prescriptions
Time frame: over a one year period
Number of subsequent visits to the outpatient clinic or medical specialist
Time frame: over a one year period
Number of visit to non-publicity funded care
Time frame: over a one year period
Disability
Time frame: 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
Change from baseline Health-related quality of life
Time frame: baseline, week 1, week 12, week 24 and 12 months follow-up
General expectations of recovery
Time frame: baseline
Perceived Global Rating of Change
Time frame: week 1, week 12, week 24 and 12 months follow-up
Patient satisfaction
Time frame: After the baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Triage, run by Université du Québec à Trois-Rivières 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 3 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: finished, as of the sponsor's last update on 28 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 28 Mar 2025.