ABCp for Lower Back Pain

(ABCp Trial)

Overseen By Jennifer N Glumpak, MScPT

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Recent accident, WCB case, contraindication to exercise, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve care for people in Alberta with lower back pain by introducing a new treatment pathway called the Alberta Back Care Pathway (ABCp). This approach trains family doctors to categorize patients into specific groups, allowing them to receive targeted, evidence-based treatments at little to no cost. The trial compares this new method to regular care to determine if it reduces healthcare use and improves patients' quality of life. People experiencing lower back pain, not related to a recent accident, and living in Alberta might be a good fit for this trial. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people, offering participants a chance to benefit from innovative care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Alberta Back Care Pathway (ABCp) is safe for managing lower back pain?

Research shows that the Alberta Back Care Pathway (ABCp) safely manages lower back pain. This pathway uses care methods proven effective through research. Studies have found no major safety issues with ABCp. As this trial is in the early stages, researchers are carefully monitoring the treatment for safety. So far, patients appear to handle it well. For any concerns or questions about joining a trial, consult your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alberta Back Care Pathway (ABCp) for lower back pain because it offers a personalized approach based on a doctor's assessment, which is different from the usual care options like medications, physical therapy, and surgery. ABCp aims to tailor interventions to the specific type of back pain a patient has, potentially leading to more effective and faster relief. This method could transform how we address lower back pain by ensuring patients get the most appropriate care for their unique condition.

What evidence suggests that the Alberta Back Care Pathway (ABCp) is effective for lower back pain?

Research has shown that the Alberta Back Care Pathway (ABCp), which participants in this trial may receive, effectively addresses low back pain by providing care based on proven methods tailored to each patient. The pathway organizes treatment into five steps, ensuring patients receive the right care at the right time. Studies have found that this approach can reduce the need for healthcare services and improve patients' quality of life. It may also help decrease the use of opioids, commonly used for pain relief. By training family doctors to use this guideline-based system, ABCp aims to make back pain care more accessible and effective. Meanwhile, another group in this trial will receive Usual Care, serving as the active comparator. ^{1 2 3 5 6}

Who Is on the Research Team?

Brandyn Powelske, MScPT

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for family physicians in Alberta treating patients with lower back pain. Physicians must be over 18, speak English, and understand written information to consent. Patients with low back pain due to recent accidents or other clinical trials are excluded.

Inclusion Criteria

This criterion refers to doctors who are allowed to participate in the study from specific healthcare networks in Edmonton and Calgary.

You have had cancer in the past or are older in age.

English speaking and a resident of Alberta who have cognition and language sufficient to understand written information, and to provide consent.

Exclusion Criteria

WCB case

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.

Timeline for a Trial Participant

Pre-implementation

Project staging and pre-implementation activities including ethics protocols, operational approvals, and training material preparation

1-6 months

Enrollment

Participants are enrolled in the study and categorized into intervention groups

12 months

Follow-up

Participants are monitored for health resource utilization and quality of life improvements

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Alberta Back Care Pathway (ABCp)
• Usual Care

Trial Overview The study tests the Alberta Back Carepathway (ABCp) against usual care. ABCp trains physicians in guideline-based interventions for lower back pain at no extra cost, aiming to reduce healthcare resource use and improve quality of life.

How Is the Trial Designed?

Group I: ABCp Experimental Treatment 1 Intervention

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

Group II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian Chiropractic Research Foundation

Collaborator

Trials

2

Recruited

270+

Bone and Joint Health SCN

Collaborator

Trials

1

Recruited

240+

Published Research Related to This Trial

A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.

The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Smith, SM., Wang, AT., Katz, NP., et al.[2023]

This systematic review analyzed 28 studies on clinical pathways for low back pain (LBP) and radicular leg pain, highlighting that these pathways can improve healthcare efficiency by reducing wait times and ensuring appropriate referrals to specialized care.

Despite showing potential benefits, the research on clinical pathways is limited and of low quality, indicating a need for well-designed randomized controlled trials to better assess their effectiveness and integration across healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pathways for the management of low back pain from primary to specialised care: a systematic review. Murphy, C., French, H., McCarthy, G., et al.[2022]

The study analyzed 11 international low back pain (LBP) care pathways, highlighting the importance of multidisciplinary collaboration and training for primary care providers to improve treatment outcomes.

Key interventions identified across these pathways include screening for red flags and psychosocial risk factors, promoting patient empowerment and self-management, and developing evidence-based protocols to guide care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International comparative study of low back pain care pathways and analysis of key interventions. Coeckelberghs, E., Verbeke, H., Desomer, A., et al.[2021]

The Alberta Ambassador Program successfully adapted seven clinical practice guidelines for low back pain into a comprehensive guideline, demonstrating a rigorous process that was well-received by participants, with an 83% response rate from 29 out of 35 committee members.

The adaptation process aligned closely with the ADAPTE framework but included enhancements that addressed specific methodological challenges, indicating a strong foundation for creating effective, multi-disciplinary guidelines for managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting low back pain guidelines within a multidisciplinary context: a process evaluation. Harstall, C., Taenzer, P., Zuck, N., et al.[2022]

A review of 91 cases of injection therapies for chronic pain revealed that 58% of patients experienced health care-related harm, often due to complications like neurologic symptoms, injury, and infection.

The study identified significant issues in clinical care, with 74% of cases criticized by peer experts, highlighting provider-related factors such as poor decision-making and failure to follow procedures, as well as team-related issues like inadequate medical record keeping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from examination of Canadian medico-legal cases related to interventional therapies for chronic pain management. MacLean, E., Garber, G., Barbosa, K., et al.[2023]

A case report highlighted a potential adverse reaction in a child from paracetamol during a clinical trial comparing it to ibuprofen for orthodontic pain relief.

The report emphasizes the need for established protocols to manage adverse events in randomized clinical trials to ensure participant safety and effective response to unexpected reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report of an adverse incident in a randomized clinical trial. McAlinden, RL., Ellis, PE., Sandy, JR.[2013]

A national care pathway for managing low back pain and radicular pain was developed in Belgium, integrating insights from 11 international pathways and 7 local initiatives, emphasizing the importance of multidisciplinary teamwork.

The pathway was constructed through a consensus approach involving various healthcare professionals and is based on established guidelines, making it a practical tool for caregivers and patients in Belgium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pivotal role for the multidisciplinary approach at all phases and at all levels in the national pathway for the management of low back pain and radicular pain in Belgium. Depreitere, B., Jonckheer, P., Coeckelberghs, E., et al.[2020]

Patients with low back pain expressed that existing care pathways often did not meet their needs, especially when pain persisted, highlighting a gap in effective treatment options.

Participants preferred personalized or hybrid care pathways and emphasized the importance of clear communication and shared decision-making between patients and clinicians for better implementation of low back pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives of care pathways for people with low back pain: A qualitative study. Boyle, EM., Fary, RE., Lee, S., et al.[2022]

In a study involving 143 community pharmacists and over 14,000 patients, drug-related problems (DRPs) were identified in 18% of patients, highlighting a significant issue in ambulatory care in Germany.

The most common DRPs included potential drug-drug interactions and insufficient patient knowledge about their medications, but over 90% of these issues were resolved through pharmacist interventions, emphasizing the critical role of pharmacists in improving medication safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-related problems in prescribed medicines in Germany at the time of dispensing. Nicolas, A., Eickhoff, C., Griese, N., et al.[2021]

The implementation of a renal pharmacist consultant service (RPCS) at hospital admission successfully identified renal drug-related problems (rDRP) in 26.9% of urological patients, leading to significant improvements in appropriate prescribing practices by physicians.

Written recommendations for prescription changes were more accepted when provided in paper form (62.5% acceptance) compared to digital format (42.9% acceptance), highlighting the importance of effective communication methods in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a renal pharmacist consultant service - Information sharing in paper versus digital form. Seiberth, S., Bauer, D., Schönermarck, U., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11602090/

The Alberta Back Care Pathway: The feasibility of ... The Alberta Back Care pathway was developed to address this gap, offering funded, evidence-based care for low back pain patients in 5 streams.

2. researchgate.net researchgate.net/publication/386177716_The_Alberta_Back_Care_Pathway_The_feasibility_of_implementing_a_novel_care_pathway_to_improve_low_back_pain_management_for_family_physicians_in_primary_care

(PDF) The Alberta Back Care Pathway: The feasibility of ... The Alberta Back Care pathway was developed to address this gap, offering funded, evidence-based care for low back pain patients in 5 streams.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05452876/alberta-back-care-pathway-abcp

Alberta Back Care Pathway (ABCp) | Clinical Research ... The primary outcome will be decreased healthcare resource utilization with secondary improvements in quality of life and opioid consumption.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39602423/

The feasibility of implementing a novel care pathway to ... The Alberta Back Care pathway was developed to address this gap, offering funded, evidence-based care for low back pain patients in 5 streams.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jebm.12582

Consensus for a primary care clinical decision‐making tool ... This clinical decision-making tool will help to standardize care, provide guidance on the diagnosis and management of LBP, and assist in ...

6. albertahealthservices.ca albertahealthservices.ca/assets/info/aph/if-aph-prov-spine-low-back-primary-care-pathway.pdf

Provincial Spine Low Back Primary Care Clinical Pathway This pathway will help primary care providers to manage low back pain within the medical home and indicate what referral triggers to watch for during ongoing ...