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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, three, six, and twelve months
Awards & highlights

AIM-BACK Trial 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.Check my eligibility
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.See study design
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.

AIM-BACK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

AIM-BACK Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pain Interference Measure
Change in Physical Function Measure
Secondary outcome measures
Change in Opioid Use--Chronic User
Change in Opioid Use--Morphine Dose
Change in Patient Reported Outcomes--PROMIS Pain Interference
+3 more
Other outcome measures
Alcohol Use Disorder
Change in Patient Reported Outcomes--Catastrophizing
Change in Patient Reported Outcomes--Depressed Mood
+3 more

AIM-BACK 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.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,504 Previous Clinical Trials
4,185,847 Total Patients Enrolled
Durham VA Medical CenterFED
38 Previous Clinical Trials
7,509 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
667,118 Total Patients Enrolled

Media Library

Nonpharmacological guideline adherent treatment protocol Clinical Trial Eligibility Overview. Trial Name: NCT04411420 — N/A
Lower Back Pain Research Study Groups: Coordinated Care Management Pathway, Integrated Care Pathway
Lower Back Pain Clinical Trial 2023: Nonpharmacological guideline adherent treatment protocol Highlights & Side Effects. Trial Name: NCT04411420 — N/A
Nonpharmacological guideline adherent treatment protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT04411420 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the overarching goals of this clinical endeavor?

"This clinical trial, which will be assessed at two intervals (baseline and three months post baseline), aims to measure Change in Physical Function Measure. Secondary objectives involve evaluating the Change in Opioid Use--Morphine Dose with morphine equivalents for opioid dose at both baseline and twelve months as a continuous variable, gauging the Change in Patient reported Outcomes--PROMIS Sleep Disturbance with PROMIS Short form scores taken by interviewers over five different time points on a scale of 1-5 where one indicates an improved outcome, and assessing the Change in Patient Reported Outcomes--PROMIS Pain Interference via PR"

Answered by AI

Is enrollment still open for the current clinical trial?

"Affirmative. According to the clinicaltrials.gov portal, this medical examination is actively seeking participants. It was first advertised on 8th March 2021 and subsequently updated 21st February 2022 with a target of 1,680 patients from one location."

Answered by AI

How many participants are being evaluated in this clinical experiment?

"Affirmative, the clinicaltrials.gov findings show this trial is open for enrollment and was initially posted on 8th of March 2021. The last update occurred on 21st February 2022 and 1680 patients are needed in one location."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Improving Veteran Access to Integrated Management of Back Pain
2021. "Improving Veteran Access to Integrated Management of Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04411420.
All > Low Back Pain > Lower Back Pain
~444 spots leftby Apr 2025
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