Integrated vs. Coordinated Pain Management for Back Pain

(AIM-BACK Trial)

Overseen By Leo Brothers, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Hospice, Palliative care, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to manage back pain without medication. One approach involves working with a pain navigator at a local clinic, while the other combines on-site physical therapy with remote services via phone or video. The trial aims to determine which method more effectively reduces pain and improves daily function. Individuals experiencing low back pain and seeking care at participating VA clinics may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative pain management solutions.

Do I need to stop my current medications for the trial?

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

What prior data suggests that these care pathways are safe for managing low back pain?

Research has shown that non-drug treatments for low back pain are generally safe and manageable. Studies have found that these treatments can reduce pain and improve movement without causing serious side effects. The American College of Physicians recommends these non-drug methods as the first choice for managing low back pain, highlighting their safety for regular use.

Participants in past studies reported few negative effects from these treatments. These methods primarily work by altering behaviors and brain processes to manage pain, utilizing the body's natural systems and reducing the risk of harmful side effects. Overall, non-drug treatments offer a safe option for effectively managing low back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative pathways for managing back pain without relying on drugs. The Coordinated Care Management Pathway stands out by using a pain navigator at local VA facilities, ensuring that patients receive guidance based on the latest treatment guidelines. Meanwhile, the Integrated Care Pathway offers a blend of on-site physical therapy and remote services via phone or video, providing flexibility and accessibility for patients. This approach is promising because it could enhance the effectiveness and convenience of back pain treatments compared to traditional methods that often rely heavily on medication.

What evidence suggests that this trial's treatments could be effective for low back pain?

Research has shown that non-medication treatments, such as exercise and physical therapy, can effectively reduce long-term low back pain. Studies have found that moderate exercise lessens pain and improves mobility. Guidelines often recommend staying active and exercising as the first choice for managing ongoing pain. In this trial, the Integrated Care Pathway offers both on-site physical therapy services and centrally-delivered services via telephone or video. The Coordinated Care Management Pathway involves referrals to a pain navigator knowledgeable in current recommended treatment guidelines. Both treatment plans focus on non-drug methods proven to reduce pain and enhance daily activities. ^{2 3 4 6 7}

Who Is on the Research Team?

Steven Z George, PT, PhD

Principal Investigator

Duke University

Susan N Hastings, MD

Principal Investigator

Duke University / Durham VA

Are You a Good Fit for This Trial?

This trial is for veterans aged 18 or older seeking conservative management for low back pain at participating VA clinics. They must not be in hospice/palliative care and need to have a documented phone number. Clinics should have distinct staff and locations from other enrolled clinics.

Inclusion Criteria

My healthcare team is ready to provide the required treatment.

My healthcare team is available to provide the required treatment.

My doctor thinks my lower back pain can be managed without surgery.

Exclusion Criteria

No documented phone number in the electronic health record

I am currently receiving or have been referred for end-of-life care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either the Integrated Care Pathway (ICP) or the Coordinated Care Management Pathway (CCP) for low back pain management

12 months

Regular visits as per care pathway protocol

Follow-up

Participants are monitored for changes in physical function, pain interference, and other outcomes using PROMIS and other questionnaires

12 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Facilitated referrals to existing VA or non-VA pain management resources
• Nonpharmacological guideline adherent treatment protocol
• Pain modulation with physical pain treatment
• Patient preference treatment protocol
• Telephone delivered behavioral treatment for participants with high risk for continued disability
• Telephone delivered self-management counseling for increasing physical activity

Trial Overview The trial tests two quality improvement pathways for managing low back pain: an Integrated Care Pathway (ICP) with sequenced treatments, and a Coordinated Care Management Pathway (CCP). It aims to see which pathway better reduces pain interference with activities and improves physical function.

How Is the Trial Designed?

Group I: Coordinated Care Management Pathway Active Control 3 Interventions

The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.

Group II: Integrated Care Pathway Active Control 3 Interventions

The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Durham VA Medical Center

Collaborator

Trials

40

Recruited

9,300+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8088811/

Pharmacological and non-pharmacological treatment ... In this review, we discuss pharmacological and non-pharmacological treatment approaches for chronic low back pain in the light of current data and guidelines.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11950946/

College of Physicians Guideline for Low Back Pain (IMPACt ... This trial will compare the effectiveness of offering non-pharmacological care options with physical therapists and doctors of chiropractic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666379125000138

An update on non-pharmacological interventions for pain ... Moderate-intensity exercise, such as muscle performance exercise and muscle strength training, is effective in reducing chronic low back pain ...

4. jospt.org jospt.org/doi/10.2519/jospt.2021.0304

Interventions for the Management of Acute and Chronic ... Since the 2012 CPG, recommendations have been made for nonpharmacologic interventions as first-choice treatments for chronic pain conditions ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-07468-0

Recent clinical practice guidelines for the management of low ... Key recommendations are placed on active treatments, including education, exercise, staying active, avoiding bed rest, and self-management.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40139265/

Non-pharmacological and non-surgical treatments for low ... Major outcomes were pain intensity, function and safety. Two authors independently assessed eligibility, extracted data and assessed the ...

7. bjsm.bmj.com bjsm.bmj.com/content/56/1/41

a systematic review with network meta-analysis With uncertainty of evidence, NS-LBP should be managed with non-pharmacological treatments which seem to mitigate pain and disability at immediate-term.