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Multimodal Back Pain Therapies for Chronic Lower Back Pain (BEST Trial)
BEST Trial Summary
This trial is looking to find the best possible treatment for chronic low back pain by testing different interventions and seeing which one works best for each individual based on their specific markers and response to treatment.
BEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBEST Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BEST Trial Design
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Who is running the clinical trial?
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- Criterion: If you have any of the following conditions, you can't participate: progressive neurodegenerative disease, spine infection or tumor, certain types of arthritis or autoimmune diseases, specific spinal cord or nerve issues, recent vertebral fracture or osteoporosis needing medication, bone-related cancer, current or recent non-skin cancer treatment, significant vision or hearing problems, uncontrolled drug or alcohol addiction, ongoing disability or injury-related legal matters, current participation in another pain study, or any other condition that the study doctor thinks would make it unsafe for you to take part.I can receive and respond to study emails.My low-back pain is worse than pain in any other part of my body.I have had low-back pain for at least 3 months, happening often.I am not advised against more than one treatment in this study.Your PEG score was 4 or higher before the trial started.I can take part in study-related phone calls.I am 18 years old or older.I am willing and able to receive at least three of the study treatments.
- Group 1: Treatment Period 1: Enhanced Self-Care (ESC)
- Group 2: Treatment Period 1: Acceptance and Commitment Therapy (ACT)
- Group 3: Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)
- Group 4: Treatment Period 1: Duloxetine
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
- 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 openings currently available to join this research initiative?
"Affirmative. Clinicaltrials.gov provides evidence that this trial, which was initially uploaded on September 12th 2022 is still actively searching for participants. In total, 820 patients need to be recruited from 12 medical centres."
What is the upper limit on the number of participants in this research endeavor?
"For this clinical trial to be successful, 820 participants who meet the criteria must join. These individuals can enroll at Stanford University in Redwood City, California and University of California San Francisco in Massachusetts."
Is Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM) a safe option for individuals?
"Based on the Phase 4 trial, Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM) has been deemed safe with a score of 3."
How many research centers are offering this experiment?
"The clinical trial has sites across 15 locations, with the major institutions being Stanford University in Redwood City California, UCSF in San Francisco and MGH/BWH Harvard Medical School of Boston Massachusetts."
Who else is applying?
What state do they live in?
How old are they?
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?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- University of Michigan: < 48 hours
- University of North Carolina Hospital Pain Management Clinic: < 48 hours
- Massachusetts General Hospital/Brigham Women's Hospital, Harvard Medical School: < 48 hours
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