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

NCT04287413 | Active Not Recruiting

• 1 other identifier: REH-755-19
• Study Type: interventional
• Target: 1,560
• Locations: 1 country
• Sites: 2

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.

Conditions

Back Pain, Low

Outcome Measures

Primary Outcomes (10)

• Self-reported Disability

  Measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Self-reported Pain Intensity

  Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity (measured at rest, during walking, and during a lifting task)

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Health Related Quality of Life

  Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Pain Self Efficacy

  Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire (0-60 score with higher scores indicating higher level of confidence in dealing with pain)

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Global Rating of Change

  Measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning related to back pain and positive scores indicating an improvement of physical functioning related to back pain)

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Satisfaction with Health Care

  Measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)

  6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Fear of Movement

  Measured using the Tampa Scale of Kinesiophobia (TSK-11) \[an 11-item questionnaire\]. Score of 11-44 with lower scores indicating less pain-related fear. The initial protocol indicated our intention to use the TSK-17, but we changed to the TSK-11 to reduce response burden prior to initiating patient recruitment.

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Catastrophic Thinking

  Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Depressive Symptoms

  Measured using the 2-item Patient Health Questionnaire (PHQ-2) (0 to 6 with greater scores indicating increased depressive symptoms). This measure was changed from the PHQ-9 to PHQ-2 after initial trial registration but prior to initiating patient recruitment reduce response burden.

  Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

• Adverse Events

  Measured using an adverse events questionnaire that asks 1) if the patient has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.

  6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

Secondary Outcomes (15)

• Health Care Accessibility

  Baseline

• Access to Physiotherapy Services

  Baseline

• Health care utilization - electronic medical record (EMR)

  12 months

• Health care utilization - self report

  12 months

• Health care utilization - self-report

  12 months

Other Outcomes (4)

• Comorbidities

  Baseline

• Baseline characteristics

  Baseline

• Risk of persistent pain and disability

  Baseline

Study Arms (2)

Physiotherapist-led primary care model for back pain

EXPERIMENTAL

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).

Behavioral: Physiotherapist-led primary care model for back pain

Usual care

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

Physiotherapist-led primary care model for back pain 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.

Physiotherapist-led primary care model for back pain

Usual care BEHAVIORAL

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

Usual care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan Miller, PT, PhD: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Interior Health

Kelowna, British Columbia, V1Y 0C5, Canada

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• Miller J, Donnelly C, McClintock C, Varette K, Camargo Y, Marsh J, Taljaard M, Mamun MSA, Bacchus G, Barber D, Cooper L, French S, Hill J, Green M, MacDermid J, Norman K, Richardson J, Tranmer J, Wideman T. Determining the Impact of a Physiotherapist-Led Primary Care Model for Low Back Pain: Protocol and Analysis Plan for a Cluster Randomized Controlled Trial and Embedded Process Evaluation. JMIR Res Protoc. 2026 Feb 26;15:e89004. doi: 10.2196/89004.

  PMID: 41747241 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jordan Miller, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the new model of care and comparison, it is not possible to blind the patients or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, School of Rehabilitation Therapy, Queen's University

Model Details: This is a cluster randomized controlled trial randomizing 20 sites to the PT-led primary care model for back pain or to the usual care model

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: February 27, 2020
• Study Start: October 2, 2023
• Primary Completion: November 25, 2025
• Study Completion: December 19, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)