We’re doing our BEST to beat chronic low-back pain

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.

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.  

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.

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.

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. 

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.

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.

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.

The BEST Trial will take place at 10 clinical sites in the United States.

Yes, you will be compensated for your time. The amount of the payments is based on the particular study activities you complete.

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.

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! 

All trial visits and tests will be provided to you at no cost.

No.  Trained experts and licensed clinicians must provide all trial tests and assessments.  All trial activities are overseen by a licensed clinician.
 

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.

Click here to email the BEST trial with questions.