If you have any questions or concerns about the enrollment process requirements for this study, please consult our FAQ section.
The BEST trial includes 4 proven treatments for chronic low back pain, but they do not always work equally well for all individuals.
A goal of the BEST trial is to learn what treatments are most effective for people based on their unique traits.
We are looking for links between peoples' traits, or phenotypes, and the effectiveness of 4 existing, proven treatments.
People 18 & up with low back pain for at least 3 months with pain at least half the days of the past 6 months may be eligible. Other criteria apply.
What does the trial's name, "BEST," mean?
BEST stands for: Biomarkers for Evaluating Spine Treatments. The main goal of the trial is to identify biomarkers or measures that might predict what treatment would be best for you.
What is a biomarker?
A biomarker is a trait – or biological marker – that can be measured. Your heart rate and blood pressure are biomarkers. Biomarkers can also be identified through x-rays, MRIs, blood tests, etc.
Can you tell me more about the BEST Trial?
There are many treatments available to help people suffering from chronic (long-term) low back pain. Research has shown that these treatments work, but there isn’t much research on what works best for a particular person. The BEST Trial is looking for a way to help doctors recommend the best treatment for their particular patient.
The BEST Trial will also help researchers learn what may be the next best treatment to try if the first treatment does not work well for a person, and which treatments might work best as an add-on to another treatment. To figure this out, the BEST Trial will study not only which study treatment(s) worked for you, but also whether or not the treatment(s) that worked for you also worked for other participants with biomarkers like yours. Knowing what works best for an individual with a particular set of biomarkers will help doctors make better treatment recommendations in the future.
Who will be enrolled in the BEST trial?
Individuals must be at least 18 years old and have had low back pain for at least 3 months and on at least half the days in the past 6 months. Other criteria apply as well.
What treatments will be studied in the BEST trial?
Participants in the BEST Trial may receive one or two of the following treatments that have shown to be effective in treating chronic low back pain:
1. Acceptance and commitment therapy (a treatment that focuses on the whole person, their pain, health and quality of life; it also helps people learn new skills for dealing with pain);
2. Duloxetine (a widely used, FDA- approved medication that helps patients manage chronic low back pain);
3. Enhanced self-care (an online program that utilizes modules and personalized messaging to teach evidence-based strategies and lifestyle skills to help patients manage their pain); and
4. Evidence-based Exercise and Manual Therapy (a combination of simple exercises, such as basic stretches and strength training, and hands-on treatment by a physical therapist or chiropractor.)
It's possible that you have already tried some version of these treatments in the past. Research has shown that they are effective in treating low back pain, but we know that they don’t work equally well for all individuals. The primary goal of the BEST Trial is to find which treatment(s) works best for a particular person.
What trial activities will I be expected to take part in, and when?
A study coordinator will first determine if you are eligible to participate in the trial by asking you a series of questions.
If you are eligible and choose to enroll, your first activity will be to engage in a 2-week online program to learn more about the trial. You will also take a few surveys during this time so that investigators can learn more about you and your low back pain.
As a participant, you will complete a total of 3 in-person visits, where you will be asked to provide a blood sample, have images of your spine taken by MRI and x-ray, and undergo a physical exam and other assessments, which are described in detail during the enrollment process. Depending on which treatment(s) you receive during the trial, you might attend additional in-person visits to receive physical therapy or telehealth visits to meet with a therapist.
Is the BEST Trial safe?
Patient safety is a priority. All treatments used in the trial have been shown to be effective and safe when delivered following accepted medical guidelines. Before enrolling in the trial, a study coordinator will explain the risks and benefits associated with the trial activities and treatments. You will also undergo a physical exam. You will not be assigned to any treatment the trial doctor thinks might be unsafe for you.
How long will I have to participate?
You will be expected to participate for 38 weeks. Participating in the trial for all 38 weeks is very important to the research, so please participate in all visits, follow-ups, and surveys; we would hate to have to drop you from the study.
Where will the BEST Trial take place?
Will I be paid to participate in the trial?
Yes, you will be compensated for your time. The amount of the payments is based on the particular study activities you complete.
Who sponsors this clinical trial?
The BEST trial is federally funded through the National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative as part of the Back Pain Consortium (BACPAC) Research Program.
Why should I join?
We know effective treatments for chronic low back pain exist. If you suffer from chronic low back pain, you have probably already tried many of them in an effort to find the one that works the best for your pain.
The BEST Trial investigators would like to help patients like you find the right treatment right away. By participating in the BEST Trial, you (and your biomarkers!) will provide a wealth of information to the trial researchers so that, in the future, doctors will be able to prescribe personalized, individual treatments that have been proven to work best for their patients who suffer from low back pain.
In addition to helping build a rich database of information on how different types of people respond to different treatments, you might also gain some more immediate benefits by participating in the trial.
It is our hope that your pain will lessen over the course of the trial, leading to improved mobility and improved ability to engage in physical, mental, cognitive, emotional, recreational, and social activities because of lessened pain. You may also benefit by gaining new knowledge about your pain or by learning new pain management techniques.
Your participation may also offer long-term benefits to your general health, such as establishing and maintaining healthy habits like exercising. While there is no guarantee that you will receive any direct benefit from being in the trial, we hope you will give it your BEST!
Who pays for the doctor visits and tests?
All trial visits and tests will be provided to you at no cost.
Can my personal doctor perform these tests?
No. Trained experts and licensed clinicians must provide all trial tests and assessments. All trial activities are overseen by a licensed clinician.
Do I have to have access to a computer or smartphone?
Yes. In order to participate in trial activities, you must have regular reliable access to an internet-enabled device such as a smart phone, tablet, or laptop computer.
I want to learn more about the BEST trial. Who do I contact?
Click here to email the BEST trial with questions.
"There are few questions in medicine more important than, 'Who benefits from what treatment?' The BEST Trial provides a rare opportunity to study this question in people with chronic low back pain.
Along the way, we will also gain valuable information about how these treatments work to ease pain and improve lives."
"Currently, we have many evidence-based treatments for chronic low back pain, but we don't have a good understanding of how to use biomarkers to guide treatment decisions. Biomarkers are specific characteristics that may be different for different people but can be reliably measured and reproduced. I am hopeful that after the BEST Trial, doctors will be better able to use biomarkers to guide decision making to select the optimum, tailored treatment for people living with chronic low back pain."
4000 Cambridge Street
Kansas City, KS 66160
325 E. Eisenhower Pkwy
Ann Arbor MI 48108
Afton L. Hassett PsyD
Associate Professor, Director of Clinical Pain Research at the Back & Pain Center
Sana Shaikh MD
Project Manager, Department of Anesthesiology
Study Coordinator, Department of Anesthesiology
Joseph Long CCRP
Study Coordinator, Department of Anesthesiology
45 Courtenay Dr.
Charleston, SC 29401
Gwendolyn Sowa MD, PhD
Professor and Chair, Department of Physical Medicine and Rehabilitation
9500 Gilman Drive MC0898
La Jolla, CA 92093-0898
Mark Wallace MD
UCSF Medical Center at Mission Bay
1500 Owens Street, San Francisco, CA 94158
Jeffrey Lotz PhD
David S. Bradford MD Endowed Chair in Orthopaedic Surgery, Professor, Vice Chair of Research
6330 Quadrangle Drive
Chapel Hill, NC 27517
1 Medical Center Blvd
Winston-Salem, NC 27157
15 Parkman Street
Boston, MA 02114
Jianren Mao MD, PhD
Vice Chair for Research and Innovation; Chief, Division of Pain Medicine
Lucy Chen MD
Associate Professor, Harvard Medical School, Massachusetts General Hospital Center for Pain Medicine
Ronald J. Kulich PhD
Professor, Tufts University School of Dental Medicine, Craniofacial Pain & Headache Center
Vitaly Napadow PhD, LicAc
Professor; Director, Scott Schoen and Nancy Adams Discovery Center for Recovery from Chronic Pain
450 Broadway Street
Pavilion A, 1st Floor
Redwood City, CA 94063
Ohio State Outpatient Care East
543 Taylor Ave
Columbus, OH 43203
1959 NE Pacific St, BB1402
Seattle, WA 98195
Kushang Patel PhD, MPH
UW Research Associate Professor, Anesthesiology & Pain Medicine
September 27, 2022
Why are we talking about pain right now? September is Pain Awareness Month.
May 31, 2022
Pain is a unique and individual experience, and there's not a one size fits all treatment plan, and that's where the BEST Trial comes in.