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Spinal Manipulation + Self-Management for Back Pain (PACBACK Trial)
PACBACK Trial Summary
This trial is looking at ways to reduce the burden of low back pain by testing scalable, first-line, non-pharmacologic strategies that address the biopsychosocial aspects of acute/sub-acute LBP and prevent transition to chronic back pain.
PACBACK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPACBACK Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PACBACK Trial Design
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Who is running the clinical trial?
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- My low back pain is not due to a physical injury.I have no medical conditions that prevent me from receiving the study treatments.I am 18 years old or older.You are at medium or high risk for having long-lasting back pain based on the STarT Back screening tool.I am currently experiencing new or recent low back pain.You have a serious health condition that needs medical attention or could get worse in the next year.My average lower back pain is 3 or more on a scale of 0 to 10.You are currently getting treatment for your low back pain from another healthcare provider.
- Group 1: Supported-Self management (SSM)
- Group 2: Spinal Manipulation Therapy (SMT)
- Group 3: SMT + SSM
- Group 4: Standard Medical Care (SMC)
- 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
Are there any more patients needed for this research project?
"Correct, the online clinicaltrials.gov registry currently lists this trial as recruiting patients. This particular study was first made public on October 25th, 2018 and updated July 12th, 2020. They are hoping to enroll 1180 individuals at 2 locations."
Does the FDA condone Spinal Manipulation Therapy as an effective treatment?
"Spinal Manipulation Therapy (SMT) has some efficacy data supporting it and multiple rounds of safety trials, so it received a score of 3."
What are the goals that this medical research is aiming to achieve?
"The goal of this trial is to observe a reduction in pain levels over the course of 10-12 months. Additionally, researchers will be monitoring for changes in self-reported coping mechanisms, self-efficacy, and frequency of low back pain episodes."
How many guinea pigs are testing this new drug?
"That is correct. Presently, the clinical trial mentioned is seeking participants. According to the data on clinicaltrials.gov, the trial was first posted on 10/25/2018 and was last edited on 7/12/2022. The trial is looking for 1180 participants between 2 sites."
Who else is applying?
What state do they live in?
What site did they apply to?
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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