NCT05452876 Alberta Back Care Pathway (ABCp)
| NCT ID | NCT05452876 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alberta |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2021-03-31 |
| Primary Completion | 2027-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2021-03-31 with a primary completion date of 2027-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Every year, the pain, disability, addiction, and expense associated with LBP increase in Alberta. This escalation is largely because most people with LBP seek care from family physicians who are unable to provide effective, guideline-based interventions due to three recognized barriers: 1) a lack of training, 2) a lack of no (or low) cost access to these interventions and 3) a lack of physician time and reimbursement to deliver these interventions. As a result, most LBP care provided in Alberta is "low-value". With input from Alberta patients, healthcare providers, administrators and international scientists, the Alberta Back Carepathway (ABCp) was designed to overcome these barriers by giving family physicians a common, guideline-based approach to coordinate, assess and manage LBP patients in day-to-day practice. The ABCp trains family physicians to quickly and easily place patients into 5 categories each having evidence-based interventions that can be provided by physicians at no or low cost to patients and no net cost to the healthcare system. By designing the ABCp to resolve barriers related to training, access and delivery, the ABCp will "pull" rather than "prod" patients and clinicians toward sustained, long-term implementation of this cost-effective solution. This study is based on a multi-clinic, controlled, non-randomized stepped-wedge study designed for urban and rural primary care networks (PCNs). The primary outcome will be decreased healthcare resource utilization with secondary improvements in quality of life and opioid consumption. Overall, the savings realized through ABCp will create a self-sustaining, scalable solution for LBP care in Alberta.
Eligibility Criteria
Inclusion Criteria: * Licensed physicians in the Edmonton West Primary Care Network (EWPCN) and the Calgary Chronic Pain Centre (CPC) * Age ≥18 years; (no upper age limit) * English speaking and a resident of Alberta who have cognition and language sufficient to understand written information, and to provide consent. * Cauda equina syndrome or infection, fracture * Single or multiple items such as age over 70, female, significant trauma, and prolonged corticosteroid use) * Cancer (single or multiple items such as older age, and previous history of cancer) * For the CPC site specifically: additional requirement of depression and anxiety as rated using the PHQ4 exclusion will include score of 3 or greater on the first two questions combined and/or score of 3 or greater on the third and 4th question combined Exclusion Criteria: * Low back pain is caused by a recent motor vehicle accident * WCB case * Any known contraindication to exercise (i.e., unstable angina, uncontrolled arrhythmia, severe aortic stenosis). * Current participation in a supervised exercise or rehabilitation program or enrolled in another interventional clinical trial. * Plans for, or undergoing, surgery that would involve the spine directly or indirectly or place them into a position where any of the interventions in this trial would be contraindicated as a result of the surgery.
Contact & Investigator
Brandyn Powelske, MScPT
STUDY DIRECTOR
University of Alberta
Frequently Asked Questions
Who can join the NCT05452876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05452876 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05452876 currently recruiting?
Yes, NCT05452876 is actively recruiting participants. Contact the research team at jjcampbe@ualberta.ca for enrollment information.
Where is the NCT05452876 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05452876 clinical trial?
NCT05452876 is sponsored by University of Alberta. The principal investigator is Brandyn Powelske, MScPT at University of Alberta. The trial plans to enroll 240 participants.