ABCp for Lower Back Pain

(ABCp Trial)

Overseen By Jennifer 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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ABCp for lower back pain?

The research suggests that clinical pathways, like the Alberta Back Care Pathway (ABCp), can improve outcomes for low back pain by coordinating care and involving patients in decision-making, which may enhance treatment effectiveness. ^{1 2 3 4 5}

Is the ABCp treatment for lower back pain safe for humans?

The available research does not provide specific safety data for the ABCp treatment for lower back pain. However, injection therapies for chronic pain, which may be similar, are generally considered safe but can have risks of adverse events. ^{6 7 8 9 10}

How is the ABCp treatment for lower back pain different from other treatments?

The Alberta Back Care Pathway (ABCp) is unique because it integrates multiple clinical practice guidelines into a single, comprehensive care pathway that spans from prevention and diagnosis to treatment, emphasizing a multidisciplinary approach and mutual decision-making between patients and clinicians. ^{1 2 3 4 5}

Research Team

Brandyn Powelske, MScPT

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Clinical pathways for the management of low back pain from primary to specialised care: a systematic review. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

International comparative study of low back pain care pathways and analysis of key interventions. [2021]

3. Italy 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. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Patient perspectives of care pathways for people with low back pain: A qualitative study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Adapting low back pain guidelines within a multidisciplinary context: a process evaluation. [2022]

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

Lessons learned from examination of Canadian medico-legal cases related to interventional therapies for chronic pain management. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Drug-related problems in prescribed medicines in Germany at the time of dispensing. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Report of an adverse incident in a randomized clinical trial. [2013]

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

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Implementation of a renal pharmacist consultant service - Information sharing in paper versus digital form. [2021]