Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain

NCT ID: NCT04287413

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2025-12-19

Brief Summary

This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for back pain in Canada.

Detailed Description

This study aims to evaluate the individual health outcomes and health system impacts of implementing a new physiotherapist-led primary care model for people with low back pain (LBP).

The overarching goal of this study is to determine the impact of integrating a physiotherapist (PT) within primary care teams for people with LBP and making them available to patients as the first point of contact. The specific aims of the research are to determine:

1. Whether a PT-led primary care model for LBP is effective at improving function (primary outcome), pain intensity, quality of life, global rating of change, and adverse events in comparison to usual physician led primary care.

2. The impact of a PT led primary care model for LBP on the healthcare system and society (healthcare access, primary care physician workload, healthcare utilization, missed work, and cost-effectiveness). A process evaluation will assess the healthcare delivered, potential mechanisms, context of implementation, and perspectives of patients and primary care providers towards the PT-led primary care model.

Conditions

Back Pain, Low

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapist-led primary care model for back pain

The index intervention will incorporate a PT within the primary care team and make them available at the first point of contact for people with low back pain. There will be 4 key components of this intervention: 1) Initial assessment and screening; 2) Brief individualized intervention at first visit; 3) Health services navigation; 4) Providing additional PT care for people with an unmet need (e.g., no insurance coverage for PT).

Group Type: EXPERIMENTAL

Physiotherapist-led primary care model for back pain

Intervention Type: BEHAVIORAL

Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination.

Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.

Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate).

Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans.

Usual care

The physician-led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. This usually includes a visit to a primary care physician, who would perform a history and physical examination, provide LBP education, order diagnostic imaging, prescribe medications and/or refer based on their assessment findings and patient preferences.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Interventions

Physiotherapist-led primary care model for back pain

Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination.

Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.

Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate).

Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans.

Intervention Type: BEHAVIORAL

Usual care

The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults (19 years and over) with low back pain of any duration who are seeking primary care for back pain at a participating site (primary care visit may be a first or repeat visit).

Exclusion Criteria

• Patients who do not consent to participation
• Patients who report being unable to understand, read, and write English
• Patients for whom the cause of their back pain is cancer

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Jordan Miller, PT, PhD

OTHER

Sponsor Role: lead

Responsible Party

Jordan Miller, PT, PhD

Assistant Professor, School of Rehabilitation Therapy, Queen's University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jordan Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Interior Health

Kelowna, British Columbia, Canada

Queen's University

Kingston, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REH-755-19

Identifier Type: -

Identifier Source: org_study_id