Evaluating a new care model for low back pain management
Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)
This study is testing a new way to manage low back pain by comparing a special care model with regular doctor visits to see which helps patients feel better and move easier.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 3 sites (Iowa City, Iowa and 2 other locations) |
| Trial ID | NCT05626049 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness of the Primary Spine Practitioner (PSP) model of care for patients with low back pain (LBP) compared to usual care provided by primary care physicians. It is a multi-site, two-arm cluster-randomized trial that evaluates patient outcomes based on changes in pain interference and physical function over three months. Participants aged 18 and older will be recruited from outpatient visits at participating clinics, and their progress will be monitored through various patient-reported outcomes and secondary endpoints over a year. The study aims to implement the American College of Physicians guidelines for LBP management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are seeking outpatient care for low back pain.
Not a fit: Patients with severe symptoms indicating cauda equina syndrome or those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and physical function for patients suffering from low back pain.
How similar studies have performed: Other studies have shown promise in similar care models, suggesting potential for improved outcomes in low back pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged 18 years and older 2. initiating an outpatient visit for LBP at a participating PCP clinic 3. agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent) Exclusion Criteria: 1. inability to provide consent or complete outcome questionnaires 2. positive screening for cauda equina symptoms (loss of total control of bowel/bladder associated with this episode of LBP )
Where this trial is running
Iowa City, Iowa and 2 other locations
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Dartmouth Health — Lebanon, New Hampshire, United States (Recruiting)
- Duke Health — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christine Goertz, PhD — Duke Clinical Research Institute
- Study coordinator: Kelley Ryan
- Email: kelley.ryan@duke.edu
- Phone: 919-668-7519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.