Back Pain, LowNCT04287413
Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain
A study testing Physiotherapist-led primary care model for back pain in people with Back Pain, Low, run by Jordan Miller, PT, PhD at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Back Pain, Low
- What is being tested?
- Physiotherapist-led primary care model for back pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 2 sitesCanada
- Study dates
- 2 Oct 2023to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Interior Health
Kelowna, British Columbia, V1Y 0C5
Queen's University
Kingston, Ontario, K7L 3N6
About this study
Official title: Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain - a Cluster Randomized Controlled Trial
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.
Read the 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:
- 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.
- Conditions
- Back Pain, Low
- Being tested
- Physiotherapist-led primary care model for back pain, Usual care
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-led primary care model for back painBehavioural
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 careBehavioural
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Disability
Measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
Measured: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Secondary outcomes (24)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Access to Physiotherapy Services
Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
Measured: Baseline
Health Care Accessibility
Percentage of patients receiving care within 48 hours.
Measured: Baseline
Health care utilization - electronic medical record (EMR)
Measuring health care utilization, from the participant's EMR, of consultations with primary care team members and access to programs offered within primary care
Measured: 12 months
Health care utilization - self report
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.
Measured: 12 months
Health care utilization - self-report
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.
Measured: 12 months
Costs
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.
Measured: 12 months
Medications Prescribed for Back Pain
Measured as a process outcome - medications prescribed for back pain will be collected in table format from the EMR.
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Number of Diagnostic Imaging Tests Ordered
Measured as a process outcome - the number of diagnostic imaging tests ordered will be collected in table format from the EMR.
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Number of Referrals Made to Other Health Care Providers
Measured as a process outcome - the number of referrals made to other health care providers will be collected in table format from the EMR.
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Number of Notes Written to Employers or Insurers
Measured as a process outcome - the number of notes written to employers or insurers will be collected in table format from the EMR.
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Education Provided by Health Care Provider
Measured as a process outcome (yes or no) and collected in table format from from the EMR
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Exercises Prescribed
Measured as a process outcome and collected in table format from the EMR
Measured: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-Report Time Lost
Self-reported time lost from work, volunteering, homemaking, and educational activities
Measured: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-Report Assistance Needed for Activities of Daily Living
Self-reported assistance needed, due to LBP, for self-care, housework, shopping, or transportation. Participants indicates on survey what they needed assistance for.
Measured: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Extra Expenses
Any extra expenses incurred as a result of LBP. Self-report
Measured: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start2 Oct 2023
- Primary completion25 Nov 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Miller, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Jordan Miller, PT, PhD, Queen's University
- Investigators
- Jordan Miller, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287413
- Sponsor's protocol ID
- REH-755-19
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Publications
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.
PubMed 41747241
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain - a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04287413
- Acronym / sponsor ID
- REH-755-19
- Conditions
- Back Pain, Low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Jordan Miller, PT, PhDUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-led primary care model for back pain | Experimental | Behavioral: Physiotherapist-led primary care model for back painThe 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). |
| Usual care | Active comparator | Behavioral: Usual careThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-led primary care model for back painAssessment 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. | Behavioural | Physiotherapist-led primary care model for back pain |
| Usual careThe physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. | Behavioural | Usual care |
Primary outcome
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)
24 secondary outcomes
Self-reported Pain Intensity
Time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Pain Self Efficacy
Time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Health Related Quality of Life
Time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Global Rating of Change
Time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Satisfaction with Health Care
Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Fear of Movement
Time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Catastrophic Thinking
Time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Depressive Symptoms
Time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Adverse Events
Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Access to Physiotherapy Services
Time frame: Baseline
Health Care Accessibility
Time frame: Baseline
Health care utilization - electronic medical record (EMR)
Time frame: 12 months
Health care utilization - self report
Time frame: 12 months
Health care utilization - self-report
Time frame: 12 months
Costs
Time frame: 12 months
Medications Prescribed for Back Pain
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups
Number of Diagnostic Imaging Tests Ordered
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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
Number of Notes Written to Employers or Insurers
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Education Provided by Health Care Provider
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Exercises Prescribed
Time frame: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-Report Time Lost
Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-Report Assistance Needed for Activities of Daily Living
Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Extra Expenses
Time frame: 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 41747241Miller 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Miller, PhD principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-led primary care model for back pain in people with Back Pain, Low, run by Jordan Miller, PT, PhD at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Disability (time frame: Change from baseline at 6-week, 12-week, 6-month, 9-month, and 12-month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.