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Multimodal Back Pain Therapies for Chronic Lower Back Pain (BEST Trial)
Phase 4
Waitlist Available
Led By Kevin Anstrom, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months
Low-back pain more severe than pain in other parts of the body
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 weeks
Awards & highlights
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.
Who is the study for?
The BEST Trial is for adults with chronic lower back pain lasting at least 3 months, who can participate in a 9-month study. They must be able to use email and internet-enabled devices, understand English, and not be excluded due to certain medical conditions or ongoing legal issues.Check my eligibility
What is being tested?
This trial evaluates four treatments for chronic low-back pain: enhanced self-care (ESC), acceptance and commitment therapy (ACT), evidence-based exercise/manual therapy (EBEM), and the medication duloxetine. It aims to develop personalized treatment plans based on individual responses.See study design
What are the potential side effects?
Duloxetine may cause nausea, dry mouth, sleepiness, constipation, loss of appetite, and increased sweating. Exercise/therapy could result in muscle soreness or strain. ACT typically has no side effects but might bring up uncomfortable emotions.
BEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had low-back pain for at least 3 months, happening often.
Select...
My low-back pain is worse than pain in any other part of my body.
Select...
I am 18 years old or older.
BEST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Patient-Reported Pain Intensity and Interference Score
Secondary outcome measures
Change in Anxiety Score
Change in Depression Score
Change in Pain Interference
+4 moreBEST Trial Design
4Treatment groups
Active Control
Group I: Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)Active Control1 Intervention
This arm includes participants who are randomized to EBEM in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on EBEM, augment EBEM with an additional treatment, or switch to a new treatment during Treatment Period 2.
Group II: Treatment Period 1: Acceptance and Commitment Therapy (ACT)Active Control1 Intervention
This arm includes participants who are randomized to ACT in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ACT, augment ACT with an additional treatment, or switch to a new treatment during Treatment Period 2.
Group III: Treatment Period 1: DuloxetineActive Control1 Intervention
This arm includes participants who are randomized to Duloxetine in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on Duloxetine, augment Duloxetine with an additional treatment, or switch to a new treatment during Treatment Period 2.
Group IV: Treatment Period 1: Enhanced Self-Care (ESC)Active Control1 Intervention
This arm includes participants who are randomized to ESC in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ESC or be randomized to augment ESC with an additional treatment during Treatment Period 2.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,186,648 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,085,926 Total Patients Enrolled
Kevin Anstrom, PhDPrincipal InvestigatorUNC Chapel Hill
5 Previous Clinical Trials
894 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)
- Group 2: Treatment Period 1: Acceptance and Commitment Therapy (ACT)
- Group 3: Treatment Period 1: Duloxetine
- Group 4: Treatment Period 1: Enhanced Self-Care (ESC)
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT05396014 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Pennsylvania
Massachusetts
Other
How old are they?
18 - 65
What site did they apply to?
University of Washington
University of California, San Francisco
Massachusetts General Hospital/Brigham Women's Hospital, Harvard Medical School
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2
3+
Why did patients apply to this trial?
I've tried everything but surgery. I would like to try study out to see will it help with my situation.
PatientReceived 2+ prior treatments
I want to see if they can find something to get rid of back pain. Plus other types of pain.
PatientReceived 2+ prior treatments
I've been on many kinds of medications that either don't work or have bad side effects. Please consider me for this trial.
PatientReceived no prior treatments
5 CAR Accidents LATER IVE SUFFERED CHRONIC PAIN for MANY YEARS AND HAVE TRIED MANI MANY SOLUTIONS ALL TO NO AVAIL I PRAY you CAN HELP.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How much are the pertisapents paid? What kind of physical activity do you have to do? How long is it for? Do you get compensated for this study? Has the study been known to help?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
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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