← Back to Search

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

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

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

Primary study objectives

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 study objectives

NIH Low Back Pain Questions

Patient Experience

Patient Satisfaction

+1 more

Other study objectives

Number of Emergency Room Visits

Number of Hospital Admissions

Number of LBP-related Imaging and Diagnostic Tests

+7 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

Do I qualify?Apply below to find out