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Physiotherapist-Led Care for Back Pain
N/A
Recruiting
Led By Jordan Miller, PhD
Research Sponsored by Jordan Miller, PT, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Patients for whom the cause of their back pain is cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new primary care model for back pain that involves physiotherapists. It will evaluate the impacts of this model on individuals and the healthcare system in Canada.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves physiotherapy rather than medication, side effects may include temporary increased discomfort or muscle soreness following treatment.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My back pain is caused by cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Catastrophic Thinking
Depressive Symptoms
+8 moreSecondary study objectives
Access to Physiotherapy Services
Costs
Education Provided by Health Care Provider
+12 moreOther study objectives
Baseline characteristics
Comorbidity
Participant Treatment Fidelity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Physiotherapist-led primary care model for back painExperimental Treatment1 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 careActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physiotherapist-led primary care model for back pain
2017
N/A
~100
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Who is running the clinical trial?
Jordan Miller, PT, PhDLead Sponsor
2 Previous Clinical Trials
308 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,516,513 Total Patients Enrolled
Jordan Miller, PhDPrincipal InvestigatorQueen's University
7 Previous Clinical Trials
1,273 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My back pain is caused by cancer.I am an adult seeking care for low back pain at a participating site.
Research Study Groups:
This trial has the following groups:- Group 1: Physiotherapist-led primary care model for back pain
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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