NCT05452876

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 low-back-pain

Timeline
20mo left

Started Mar 2021

Longer than P75 for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Mar 2021Dec 2027

Study Start

First participant enrolled

March 31, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

6.7 years

First QC Date

May 9, 2022

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary Care visits

    Number of GP revisits for LBP

    Through study completion, an average of 30 months

Secondary Outcomes (2)

  • GP ordered LBP imaging

    Through study completion, an average of 30 months

  • GP requested specialist consultations

    Through study completion, an average of 30 months

Study Arms (2)

ABCp

EXPERIMENTAL

The patient sees MD that follows ABCp, patient then enrolls in ABCp intervention based on MD's categorization of low back pain.

Other: ABCp

Usual Care

ACTIVE COMPARATOR

The patient receives "usual care" at the clinical site.

Other: Usual Care

Interventions

ABCpOTHER

Intervention is a care pathway that helps primary care physicians categorize back pain patients with each category having preferred interventions.

ABCp

Standard of care treatment

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brandyn Powelske, MScPT

    University of Alberta

    STUDY DIRECTOR

Central Study Contacts

Jennifer N Glumpak, MScPT

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: non-randomized, stepped-wedge, multi-clinic (cluster) prospective cohort design having multiple controls within a primary care setting
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

July 11, 2022

Study Start

March 31, 2021

Primary Completion (Estimated)

December 17, 2027

Study Completion (Estimated)

December 17, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations