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Primary Spine Provider Model for Low Back Pain (IMPACt-LBP Trial)
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.
IMPACt-LBP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IMPACt-LBP Trial Design
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Who is running the clinical trial?
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- I am starting treatment for lower back pain at a clinic.I am 18 years old or older.I have lost total control of my bowel or bladder with this back pain episode.
- Group 1: Usual Medical Care
- Group 2: Primary Spine Provider Model
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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