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NCT Number: NCT04287413

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interior Health, Kelowna, British Columbia, Canada

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Behavioral

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

Primary outcomes

  1. Self-reported Disability

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

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

  2. Self-reported Pain Intensity

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

    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)

  3. Health Related Quality of Life

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

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

  4. Pain Self Efficacy

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

    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)

  5. Global Rating of Change

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

    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)

  6. Satisfaction with Health Care

    Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

    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)

  7. Fear of Movement

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

    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.

  8. Catastrophic Thinking

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

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

  9. Depressive Symptoms

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

    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.

  10. Adverse Events

    Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

    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.

Secondary outcomes

  1. Health Care Accessibility

    Time frame: Baseline

    Percentage of patients receiving care within 48 hours.

  2. Access to Physiotherapy Services

    Time frame: Baseline

    Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.

  3. Health care utilization - electronic medical record (EMR)

    Time frame: 12 months

    Measuring health care utilization, from the participant's EMR, of consultations with primary care team members and access to programs offered within primary care

  4. Health care utilization - self report

    Time frame: 12 months

    Measuring health care utilization (self-report survey): visits to health professionals outside of the primary care team (e.g. chiropractors, massage therapists, occupational therapists, physiotherapists, social workers), medication use, and visits to walk-in clinics.

  5. Health care utilization - self-report

    Time frame: 12 months

    Measuring health care utilization from self-report survey: diagnostic imaging for the spine, pain injections or interventional procedures received, specialist visits for low back pain, hospital stays related to back pain and dysfunction, and emergency department visits for back pain. The collection of this healthcare utilization data changed from using health administrative data in Ontario accessed through the Institute for Clinical Evaluative Sience (IC/ES) to using a self-report survey prior to the initiation of patient recrutiment when we recruited sites in British Columbia.

  6. Costs

    Time frame: 12 months

    Includes all health care costs (including: primary care visits, emergency department visits, hospitalizations, surgeries, consultations with other health care providers, diagnostic imaging, medications, and other care received by the patient) plus societal costs using a human capital approach for loss of productivity.

  7. Medications Prescribed for Back Pain

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups

    Measured as a process outcome - medications prescribed for back pain will be collected in table format from the EMR.

  8. Number of Diagnostic Imaging Tests Ordered

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome - the number of diagnostic imaging tests ordered will be collected in table format from the EMR.

  9. Number of Referrals Made to Other Health Care Providers

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome - the number of referrals made to other health care providers will be collected in table format from the EMR.

  10. Number of Notes Written to Employers or Insurers

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome - the number of notes written to employers or insurers will be collected in table format from the EMR.

  11. Education Provided by Health Care Provider

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome (yes or no) and collected in table format from from the EMR

  12. Exercises Prescribed

    Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Measured as a process outcome and collected in table format from the EMR

  13. Self-Report Time Lost

    Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Self-reported time lost from work, volunteering, homemaking, and educational activities

  14. Self-Report Assistance Needed for Activities of Daily Living

    Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Self-reported assistance needed, due to LBP, for self-care, housework, shopping, or transportation. Participants indicates on survey what they needed assistance for.

  15. Extra Expenses

    Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

    Any extra expenses incurred as a result of LBP. Self-report

Other outcomes

  1. Comorbidities

    Time frame: Baseline

    Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).

  2. Baseline characteristics

    Time frame: Baseline

    To describe the study population, the investigators will capture the following through the survey: age, sex, gender, identification as indigenous (First Nations, Inuit, Métis), duration and history of LBP, level of education achieved, household income, and work status.

  3. Risk of persistent pain and disability

    Time frame: Baseline

    Measured using the STaRT Back tool to group participants into low, medium, and high risk groups

  4. Participant Treatment Fidelity

    Time frame: 6-weeks

    Self-report adherence to physiotherapy advice

Sponsors and collaborators

Lead sponsor

Jordan Miller, PT, PhD

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2020
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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