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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
Other: Triage results undisclosed
Following the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will not be communicated to the specialist.
Intervention group
Other: Triage results disclosed
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université du Québec à Trois-Rivières

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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