Physiotherapist-Led Care for Back Pain

Not currently recruiting at 1 trial location

Overseen By Kevin Varette, Msc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jordan Miller, PT, PhD

Disqualifiers: Non-consent, Language barrier, Cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a new approach to treating back pain, led by physiotherapists, with the usual care provided by doctors. The researchers seek to determine if having a physiotherapist as the first point of contact for back pain can enhance individual health and benefit Canada's healthcare system. Participants will receive either this new physiotherapist-led care or the usual doctor-led care. Ideal candidates are adults experiencing low back pain and seeking primary care assistance.

As an unphased trial, this study allows patients to contribute to innovative healthcare solutions and potentially improve their own treatment outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this physiotherapist-led primary care model for back pain is safe?

Research shows that the physiotherapist-led care model for back pain is generally safe. Although specific safety data for this model is lacking, physiotherapy is a well-known treatment. It typically involves exercises and techniques considered low-risk.

Most people tolerate physiotherapy well, and negative reactions are rare. Many participants report positive experiences, and both patients and care team members have noted good outcomes. This suggests that the treatment is generally safe and well-accepted.

Since this is not a drug treatment, there are no concerns about medication side effects. Those with specific medical conditions or concerns should consult a healthcare provider before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the physiotherapist-led primary care model for back pain because it introduces a new way to manage this common condition right from the first point of contact. Unlike traditional care, which typically involves a physician assessing and prescribing medication or imaging, this model integrates a physiotherapist into the primary care team. Key features include an initial assessment and screening by a physiotherapist, followed by a tailored intervention and guidance through health services. This approach could improve access to specialized care and potentially address unmet needs, especially for those lacking insurance coverage for physiotherapy.

What evidence suggests that the physiotherapist-led primary care model is effective for back pain?

This trial will compare a physiotherapist-led primary care model for back pain with usual care. Research has shown that physiotherapist-led care can effectively treat low back pain. Studies have found that when physiotherapists join primary care teams, patients experience positive outcomes and improved health. This approach is considered a clinically effective, quick, and cost-saving method for managing back pain. Patients often receive personalized care promptly, which can better manage their symptoms. However, while some results are encouraging, the overall certainty of the evidence remains low, necessitating further research to confirm these benefits. ^{1 3 4 6 7}

Who Is on the Research Team?

Jordan Miller, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for adults over 19 with low back pain seeking primary care at a participating site. It's not for those who can't consent, don't understand English, or have cancer-related back pain.

Inclusion Criteria

I am an adult seeking care for low back pain at a participating site.

Exclusion Criteria

My back pain is caused by cancer.

Patients who report being unable to understand, read, and write English

Patients who do not consent to participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Screening

Initial assessment and screening by a physiotherapist as part of the primary care model

1 visit

1 visit (in-person)

Treatment

Participants receive a brief individualized intervention at the first visit, health services navigation, and additional PT care if needed

12 months

Multiple visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 6-week, 12-week, 6-month, 9-month, and 12-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• Physiotherapist-led primary care model for back pain
• Usual care

Trial Overview The study compares a new physiotherapist-led primary care model against usual care to see how it affects individuals and the healthcare system in managing low back pain.

How Is the Trial Designed?

Group I: Physiotherapist-led primary care model for back pain Experimental Treatment 1 Intervention

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 II: Usual care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Jordan Miller, PT, PhD

Lead Sponsor

Trials

4

Recruited

1,800+

Jordan Miller, PT, PhD

Lead Sponsor

Trials

4

Recruited

1,800+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study of 126 women treated with taxane-based chemotherapy for breast cancer, 73% reported experiencing chemotherapy-induced peripheral neuropathy (CIPN), which significantly affected their quality of life and physical functioning.

CIPN severity was notably higher in Black or African American women, indicating a need for targeted screening and intervention strategies to address this disparity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. Simon, NB., Danso, MA., Alberico, TA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5680754/

Determining the impact of a new physiotherapist-led ... This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain.

2. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-022-01817-5

Implementing a new physiotherapist-led primary care model ... A new physiotherapist-led primary care model for LBP was described by patients and primary care team members as contributing to positive experiences and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04287413

Determining the Impact of a New Physiotherapist-led ... 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39328010/

Physiotherapy-led care versus physician ... Physiotherapy-led care is a clinically, time- and cost-effective care pathway for low back pain, although the certainty of evidence was overall very low.

5. trialx.com trialx.com/clinical-trials/listings/217066/determining-the-impact-of-a-new-physiotherapist-led-primary-care-model-for-low-back-pain/

Determining the Impact of a New Physiotherapist-led ... This study aims to evaluate the individual health outcomes and health system impacts of implementing a new physiotherapist-led primary care ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35948876/

a qualitative study of patient and primary care team ... Implementing a new physiotherapist-led primary care model for low back pain: a qualitative study of patient and primary care team perspectives.

7. withpower.com withpower.com/trial/phase-back-pain-9-2021-dc8d4

Physiotherapist-Led Care for Back Pain · Info for Participants The research does not provide specific safety data for physiotherapist-led care for back ... Physiotherapist-led primary care model for back pain; Usual care.