The Effect of Chiropractor-informed Triage on Low Back Pain Patient Outcomes and Trajectories

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923308
• Other study ID #: UQTR-2021-triage
• Status: Recruiting
• Start date: July 6, 2021
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Université du Québec à Trois-Rivières
• Contact: Martin Descarreaux, PhD
• Phone: 819-376-5011
• Email: martin.descarreaux[@]uqtr.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Triage

Intervention

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

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivieres	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	up to 4 weeks post-baseline assessment
Secondary	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.	over a one year period
Secondary	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.	over a one year period
Secondary	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.	over a one year period
Secondary	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.	over a one year period
Secondary	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.	over a one year period
Secondary	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	baseline, week 1, week 12, week 24 and 12 months follow-up
Secondary	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.	over a one year period
Secondary	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	baseline, week 1, week 12, week 24 and 12 months follow-up
Secondary	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''	baseline
Secondary	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	week 1, week 12, week 24 and 12 months follow-up
Secondary	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.	After the baseline assessment