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Primary Spine Provider Model for Low Back Pain (IMPACt-LBP Trial)

Phase 4
Recruiting
Led By Christine Goertz, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

IMPACt-LBP Trial Summary

This trial tests if a new care-model for treating low back pain leads to better outcomes in patients than usual care.

Who is the study for?
This trial is for adults over 18 who are starting outpatient treatment for low back pain at a participating clinic. They must be able to give consent and fill out a baseline questionnaire. People with severe symptoms like loss of bowel/bladder control or worsening muscle weakness cannot join.Check my eligibility
What is being tested?
The study compares two ways to treat low back pain: the Primary Spine Provider Model, which focuses on spine care specialists, versus Usual Care, where patients see general healthcare providers. It measures changes in how much pain affects their life and physical function after three months.See study design
What are the potential side effects?
Since this trial involves different models of care rather than medication, side effects are not typical as with drug trials. However, there may be differences in satisfaction or effectiveness between the two approaches.

IMPACt-LBP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months 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 as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Secondary outcome measures
NIH Low Back Pain Questions
Patient Experience
Patient Satisfaction
+1 more
Other outcome measures
Number of Emergency Room Visits
Number of Hospital Admissions
Number of LBP-related Imaging and Diagnostic Tests
+7 more

IMPACt-LBP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Primary Spine Provider ModelExperimental Treatment1 Intervention
This group will consist of patients who contact clinics that have been randomized to the primary spine provider (PSP) model (intervention clinics). Patients seeking care at intervention clinics will be given the option of seeing either a DC or a PT as their first contact clinician for an initial trial of PSP care.
Group II: Usual Medical CareActive Control1 Intervention
This group will consist of patients who contact clinics that have been randomized to usual medical care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,355 Previous Clinical Trials
3,407,219 Total Patients Enrolled
15 Trials studying Back Pain
5,523 Patients Enrolled for Back Pain
Dartmouth-Hitchcock Medical CenterOTHER
522 Previous Clinical Trials
2,540,694 Total Patients Enrolled
4 Trials studying Back Pain
1,196 Patients Enrolled for Back Pain
University of IowaOTHER
444 Previous Clinical Trials
876,910 Total Patients Enrolled
5 Trials studying Back Pain
1,069 Patients Enrolled for Back Pain

Media Library

Primary Spine Provider Model Clinical Trial Eligibility Overview. Trial Name: NCT05626049 — Phase 4
Back Pain Research Study Groups: Usual Medical Care, Primary Spine Provider Model
Back Pain Clinical Trial 2023: Primary Spine Provider Model Highlights & Side Effects. Trial Name: NCT05626049 — Phase 4
Primary Spine Provider Model 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626049 — Phase 4
Back Pain Patient Testimony for trial: Trial Name: NCT05626049 — Phase 4

Frequently Asked Questions

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

What are the fundamental aims of this research project?

"This clinical trial's primary outcome will be to gauge the Change in Physical Function via PROMIS (Patient-Reported Outcomes Measurement Information System) over a Baseline, 3 Months period. Secondary metrics include counting LBP-related Medical Prescriptions extracted from electronic health records using standard codes, gauging Patient Satisfaction with care through a single item survey query and NIH Low Back pain Questions consisting of two items used to determine chronicity."

Answered by AI

Are there any available slots remaining in this trial?

"Data on clinicaltrials.gov reveals that this research project, which was initially published in November 1st 2022, is not currently seeking patients. However, there are 332 other trials accepting volunteers at the moment."

Answered by AI

Is the Primary Spine Provider Model conducive to patient safety?

"Our assessment of the Primary Spine Provider Model ranked its safety as a 3 on our 1-3 scale, owing to it being in Phase 4 trials and thus approved for use."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Constant pain no relief.
PatientReceived 1 prior treatment
~900 spots leftby Apr 2025