NCT04923308

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

3.4 years

First QC Date

June 2, 2021

Last Update Submit

March 24, 2025

Conditions

Keywords

Low back paintriagecare pathwayschiropractorpaindisabilityhealth resources

Outcome Measures

Primary Outcomes (1)

  • 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').

    baseline, week 1, week 12, week 24 and 12 months follow-up

Secondary Outcomes (12)

  • Diagnosis made by the specialist

    up to 4 weeks post-baseline assessment

  • Number of requests for medical imaging

    over a one year period

  • Number of requests for laboratory tests

    over a one year period

  • Number of requests for medication prescriptions

    over a one year period

  • Number of subsequent visits to the outpatient clinic or medical specialist

    over a one year period

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

Other: Triage results disclosed

Control group

Other: Triage results undisclosed

Interventions

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.

Intervention group

Following the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will not be communicated to the specialist.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Patients involved in litigation related to their LBP condition (i.e., worker's compensation, public automobile insurance plan or other litigations)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 11, 2021

Study Start

July 6, 2021

Primary Completion

November 27, 2024

Study Completion

November 27, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations