Participants are randomly assigned to an initial treatment for 3 months, which could then be modified depending on how they respond. The change may include switching to another treatment, combining two treatments, or continuing the initial treatment. One thing that’s special about the BEST trial is how it has been designed to help patients identify what works for them as quickly as possible.
This approach is called a Sequential Multiple Assignment Randomized Trial, or SMART. It is a research strategy that “learns as it goes,” adapting over time to the responses and needs of an individual research participant. It is a way to individualize treatment: continue the treatment, increase or decrease the dose, or switch to another approach.
“SMARTs are considered the gold standard design for evaluating dynamic treatment regimens and developing tailored strategies for chronic disease conditions such as low back pain,” says Kevin Anstrom, Ph.D., also at UNC-Chapel Hill. “It is the ideal approach to develop patient-centered strategies.”
“For example, one participant in our trial improved dramatically with physical therapy in the first 3 months of the study,” explains Mauck. “Given this excellent response, for the second 3 months, they will continue with physical therapy.”
But if an individual doesn’t do so well with a treatment in the trial, or gets worse, that person would be switched to a different treatment. Other individuals that show some improvement might have another treatment layered on.
Tracking Pain in Individuals
Pain is a biopsychosocial condition, meaning that it is influenced not only by what is happening in our organs and tissues, but also by psychological factors like emotions and social interactions.
The BEST trial is looking for patient-specific biological characteristics known as biomarkers, which are health attributes that can be measured, such as heart rate and blood pressure. Other pain-related examples include measurements from X-rays or magnetic resonance imaging (MRI), measurements that track the range of motion of the spine and torso, physical activity (for example, the number of steps a person takes in a day), and molecular changes in muscle and bone.
Psychological measurements, including mental health symptoms, are also captured. “We’re measuring how an individual is feeling related to anxiety and depression and how that might influence their pain experience,” explains Gwendolyn Sowa, M.D., Ph.D., at the University of Pittsburgh. These co-occurring conditions are common in people who live with chronic pain – other HEAL-funded BACPAC research is testing whether treating mood and pain together can provide relief for people with chronic low back pain.
Guiding Future Treatment for Providers and Patients
Importantly, BEST trial researchers are turning directly to patients for descriptions of their pain and effects on their quality of life. Response to any of the treatments may include pain relief; improved mobility; and improved ability to engage in physical, mental, cognitive, emotional, recreational, and social activities. Patient-reported information is a critical element to guide interpretation of pain clinical research studies.
The results from this study should help researchers develop personalized therapies and give providers and patients guidance on what to do if the first treatment does not work well for a person. The hope is that people with a particular set of biomarkers may respond the same to certain treatments because their experience of pain is similar.
The HEAL-funded BEST team hopes that the research findings will be broadly generalizable. This is because the people participating in the trial are a large and diverse group, representative of back pain patients that are seen across the country, in primary care offices, pain clinics, and spine centers. The scientists and their teams have been intentional in trying to recruit a diverse set of participants – which is important for ensuring that results apply to a large section of the population and reflect U.S. diversity. For example, one research team spread the word about the BEST trial at a weekend community health fair in honor of the Juneteenth holiday.
The goal of all clinical research is to learn if a treatment works, or whether one type of therapy is better than another. The BEST clinical trial’s goal is to answer specific research questions about how biomarkers can guide treatment. The answers may help patients in real-time, as they are switched from one treatment to another.
Through the growing body of knowledge from the BEST trial and other HEAL-funded clinical research on chronic back pain, providers will have more precise, patient-tailored information to guide developing treatment plans with their patients. HEAL research is working to define a future in which individuals can choose from multiple safe and effective options for long-term pain relief.
BEST Clinical Trial
Learn more about the Biomarkers for Evaluating Spine Treatments (BEST) clinical trial.