Physiotherapist-Led Care for Back Pain

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

1560 Participants Needed

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the physiotherapist-led primary care model for back pain?

Research suggests that physiotherapy management can help improve quality of life for patients with chemotherapy-induced peripheral neuropathy (CIPN) by managing symptoms and enhancing function. This indicates that physiotherapy, as a treatment approach, may also be beneficial for managing back pain by improving patients' ability to participate in daily activities. ^{1 2 3 4 5}

Is physiotherapist-led care for back pain generally safe for humans?

The research does not provide specific safety data for physiotherapist-led care for back pain, but physiotherapy is generally considered safe for managing various conditions, including chemotherapy-induced peripheral neuropathy. ^{1 2 6 7 8}

How does the physiotherapist-led care model for back pain differ from usual care for chemotherapy-induced peripheral neuropathy?

The physiotherapist-led care model for back pain is unique because it focuses on improving physical function and quality of life through personalized exercises and activities, unlike usual care for chemotherapy-induced peripheral neuropathy, which primarily involves standard medications and symptom management. ^{1 6 9 10 11}

Research Team

Jordan Miller, PhD

Principal Investigator

Queen's University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. South Africa pubmed.ncbi.nlm.nih.gov

Physiotherapy management of chemotherapy-induced peripheral neuropathy in Pretoria, South Africa. [2022]

2. Netherlands 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. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Peripheral Neuropathy under Oncologic Therapies: A Literature Review on Pathogenetic Mechanisms. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term Peripheral Neuropathy in Breast Cancer Patients Treated With Adjuvant Chemotherapy: NRG Oncology/NSABP B-30. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A prospective study on the neurological complications of breast cancer and its treatment: Updated analysis three years after cancer diagnosis. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Characterization of Internal Validity Threats to Phase III Clinical Trials for Chemotherapy-Induced Peripheral Neuropathy Management: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy-induced peripheral neuropathy: where are we now? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy-induced peripheral neuropathy: an algorithm to guide nursing management. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy-Induced Peripheral Neuropathy: Use of an Electronic Care Planning System to Improve Adherence to Recommended Assessment and Management Practices. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Development of the consensus-based recommendations for Podiatry care of Neuropathy In Cancer Survivors (PodNICS): a Delphi consensus study of Australian podiatrists. [2023]