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Integrated vs. Coordinated Pain Management for Back Pain (AIM-BACK Trial)

N/A

Waitlist Available

Led By Steven Z George, PT, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18

Be older than 18 years old

Must not have

Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, three, six, and twelve months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an Integrated Care Pathway or a Coordinated Care Pathway is more effective in reducing pain and improving function for people with low back pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions include non-pharmacological treatments like behavioral therapy, physical treatment, self-management counseling, and referrals to pain resources, side effects are minimal but may include discomfort due to increased activity or psychological distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, three months post baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, three months post baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, three months post baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Interference Measure

Change in Physical Function Measure

Secondary study objectives

Change in Opioid Use--Chronic User

Change in Opioid Use--Morphine Dose

Change in Patient Reported Outcomes--PROMIS Pain Interference

+3 more

Other study objectives

Alcohol Use Disorder

Change in Patient Reported Outcomes--Catastrophizing

Change in Patient Reported Outcomes--Depressed Mood

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Coordinated Care Management PathwayActive Control3 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 PathwayActive Control3 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.

0 / 2Eligibility criteria met