SMART Low Back Pain (LBP) Trial: A Q&A with Julie Fritz, PT, PhD, FAPTA
The Sequential Multiple Randomization Trial for Low Back Pain (SMART LBP Trial) will enable better integration of the biopsychosocial model and improve Stepped Care management with a pragmatic, randomized controlled trial targeting chronic low back pain at four large military installations in the United States.
Julie Fritz PT, PhD, FAPTA, is a distinguished professor and Associate Dean of Research at the University of Utah’s Department of Physical Therapy at the College of Health in Salt Lake City. Her clinical background is in physical therapy and her research interests are focused on studying interventions for individuals with chronic pain, particularly spinal pain, with a focus on non-pharmacologic interventions that physical therapists typically deliver.
Daniel (Dan) Rhon, DSc, DPT, is the Director of Primary Care Musculoskeletal Research at the Brooke Army Medical Center and an ORISE Research Fellow with the Military Performance Lab at the US Army Research Institute of Environmental Medicine (USARIEM). Dr. Dan Rhon is also an Assistant Professor at Baylor University in Texas and an Assistant Professor at Duke University Medical Center’s Department of Orthopaedic Surgery in Durham, North Carolina. Rhon is a retired military medical officer from the US Army.
PMC talked with Julie Fritz about the SMART Trial, on which she is co-PI with Dan Rhon.
A: The SMART Low Back Pain (LBP) Trial is evaluating care sequences to identify the pattern of care that might be best for patients with chronic back pain. The first phase of this two-phased trial is examining the treatment of chronic back pain with either physical therapy or through a military health program called Move 2 Health, which is a holistic, health coaching-based approach to manage chronic conditions. Both treatments are commonly available and viewed as first-line interventions within the military health system.
In the second phase, individuals who have self-reported to be non-responsive to the initial treatment, are randomized into two options. The first option is being treated with a combination of both of the two first-line interventions. So, those getting physical therapy, will now also participate in Move 2 Health, and vice versa. The second option is a switch to a mindfulness treatment program, which is a fairly intensive engagement in an eight-week mindfulness program that one of our colleagues has developed and piloted in the military health system, as well as in civilian health systems.
The SMART LBP Trial a collaborative effort between the academic resources at the University of Utah (where I’m based) and a group of military treatment facilities, which are health care facilities located on military bases. For our project, we have three participating sites that have been recruiting patients for us. Two are located in San Antonio: Wilford Hall, which is an Air Force base, and Brooke Army Medical Center. The third is Madigan Army Medical Center in Tacoma, Washington.
A: SMART design is an acronym indicating Sequential, Multiple Randomization in Trial design. It essentially tries to reflect the clinical reality of treating individuals with chronic pain, which is that there is no single magic bullet treatment that works consistently and successfully for every patient with chronic back pain. In the real world, patients try something that's offered to them as first-line care. If that treatment doesn't work for the patient, meaning that they didn't get the results they're looking for, they move along to something else, and the process repeats. Traditional clinical trial design is not really capable of reflecting that pattern of care seeking. So, in our trial, we begin by randomizing patients to either Move 2 Health or physical therapy, and then for individuals who are determined (based on self-reported measures) to be non-responsive to the initial treatment, we re-randomize them to one of two options that we view as an intensification of the treatment.
A: Move 2 Health (M2H) is very much analogous to the VA health system’s efforts around Whole Health, and both leverage various resources to help the patient develop a self-management plan for their condition and become engaged with their own self-care
A: In many ways, chronic back pain as a phenomenon manifests itself in active duty service members in exactly the same way it does for anybody else. My experience (as someone who is not an active duty military member—and has never been—but does research in this population) is that people are people. So, their potential responsiveness to treatment and the issues around compliance and motivation are the same as in the civilian world. Additionally, in both the civilian world and in military environments, the issues surrounding the overuse of opioids for pain management are of large concern. So, finding better ways to manage pain other than relying on pharmaceuticals is critical for all.
Yet, in other ways, chronic pain among active duty service members is certainly different and unique. From a leadership perspective, placing a spotlight on addressing a condition like chronic pain takes on a different flavor when you're working with active duty military personnel; the impact of back pain on an individual's career in a military context can be of great significance. In the military, there is a great deal of focus on chronic musculoskeletal pain, and back pain in particular, because it's one of the most common reasons for medical discharge from the military or being removed from an overseas deployment. Additionally, the healthcare delivery system is a different model. Similar to the VA Health System, patient payment responsibility is less of an issue. That payment model is obviously very different in the civilian world, and that creates a different set of incentives and disincentives for certain types of care.
A: When you ask what usual care is, it's amazingly hard to define. I can tell you what the guidelines say, and I think in general it's reasonably reflective of what tends to happen, which is: when people are dealing with chronic pain, they usually seek initial care for their pain in a primary care setting. The current guidelines to primary care practitioners include avoiding imaging and opioids for first-line pain management, and engaging the patient in non-pharmacologic options.
Military health systems are beginning to develop more non-pharmacologic options to meet those recommendations. The VA health system is a bit ahead of the curve, as they have resources for integrative health solutions, patient self-management solutions, exercise options, and various wellness opportunities at many of their facilities. I see those components growing in the military health system with increasing recognition that these kinds of options for patients are very beneficial.
A: At its core, the biopsychosocial model recognizes that a person’s psychological state and social interactions have a synergistic effect on that person’s wellbeing, and, in this instance, their experience of pain. If patients don't understand the connections, it can work to their detriment since they may not be actively aware of the situations, factors, and personal interactions that also play an important role in their experience of pain. This includes situations that increase their stress, factors that negatively impact their mood, and their interactions and relationships with family, friends or other kinds of social settings. For providers, not paying sufficient attention to the really critical roles of these various domains in a patient's recovery is often partly to blame for inadequate therapeutic response to a lot of the treatments that we deliver. The experience of chronic pain cannot be over-simplified into a biological phenomenon and one-size-fits-all treatment—that if I stretch the correct muscle or move a joint in certain way that I, as the provider, will fix it for the patient. If it were really possible to do that, it would be great, but for chronic pain, it just doesn't really work out that way in the vast majority of cases. When there's not an adequate amount of attention paid to the other elements of the biopsychosocial model, treatments tend not to be very effective for patients.
A: It’s really important to provide patients with open-ended opportunities to reflect on their pain, and how it impacts all dimensions of their lives. There are several techniques that can help patients begin to at least contemplate, if not be able to articulate, how pain is influencing their life from a more holistic perspective. Creating a nonjudgmental environment for patients to reflect and articulate is essential, no matter the treatment setting. Say, for instance, the patient is under the care of a physical therapist. The patient may be concerned that they may be stigmatized for bringing up aspects from psychosocial domains; or they fear that the provider will think that the pain is all in their head, and somehow their pain isn’t real, but a reflection of difficulties in current life situations. So, it is important for providers to convey that a patient’s mental wellbeing, physical pain, life situations, and health at large are inextricably bound together and create a safe space for patients to talk about what they associate with their pain.
Providers need to view their patients more holistically. Some questions to ask to help create these nonjudgmental, open-ended opportunities for patients to articulate the biopsychosocial aspects of their pain include:
- How have you been sleeping?
- What stressors do you have in your life?
- What other aspects in your life might be affecting your pain?
- Can you think of ways your mood, amount of sleep and stress, as well as your current relationships might help or hinder your experience of pain, or ability to follow treatments?
A: When COVID-19 emerged, we had just started recruiting patients for our study. We'd brought in about 30 participants, and we were just getting our feet on the ground. The restrictions on in-person care delivery created complications for our study since we designed the interventions to be done in person, particularly for the physical therapy component since physical touch is at the core of physical therapy, both in assessment and treatment. In the considerations that we were making right as COVID was ramping up, we were concerned that shifting to remote delivery, particularly for our physical therapy intervention, was going to really fundamentally change our research questions and decrease the sense of clinical equipoise that we started out the study with, which is a really important concept in clinical trials.
There's not a lot of research on physical therapy delivered entirely remotely. Patients have concerns about how effective remote physical therapy would be, and providers’ comfort level with that delivery was, I think, very low, early on, especially. So, the decision we had to make was to suspend our enrollment until in-person care at our study’s participating military treatment facilities reached the threshold level where we believed we could start the study, and not create complications for the limited amount of in-person care that was going on. This was often limited to just the highest priority patients who were oftentimes either trauma patients or individuals who were recovering from surgery, where not having access to in-person physical therapy was viewed as potentially detrimental to their recovery. More chronic conditions were not viewed in the same priority way, and we certainly did not want to try to prioritize patients that were part of our study and disrupt the priorities of the facilities in terms of who should receive in-person care.
A: COVID has been really challenging for many, but particularly so for individuals who are dealing with a chronic condition, like chronic pain that's already often associated with stress, anxiety, low mood. The type of restrictions that COVID has produced are having some really negative consequences for those individuals. We're starting to see a bit of this reflected in the research in terms of a return to reliance on pharmaceutical interventions because a lot of the non-pharmacologic options may now be more limited. The entire situation places increased stress and anxiety on patients. I think we're going to be dealing with the manifestations and consequences of COVID for a lot of individuals with chronic pain well beyond the hopeful end or cessation of this pandemic. This abrupt and pretty long-lasting disruption in the normal self-management strategies adopted by many people is going to present challenges to reformulate those self-management patterns after restrictions lift and things are a bit more normal.
A: The Pain Management Collaboratory offers a tremendous value-added opportunity. As a researcher, just the opportunity to get to know colleagues and dialogue with them likely wouldn't have been possible were it not for the Collaboratory, so it's really been very professionally satisfying for me. This has been an incredibly enriching and beneficial experience, and I don't think I'm alone in saying that for those of us who are part of this Collaboratory. The other valuable asset that the Collaboratory brings is the collective wisdom of the group. Having a wealth of expertise to ask questions of, to talk through concerns, and to see how other people are handling certain things, has really been invaluable. The importance of having this level of collaboration was made even more evident to me with COVID. I think it's been a great example of the sum of the parts creating a greater and more valuable product than any of the individual pieces could have ever done in isolation. I think it's going to make all of our research projects better and more informative to policy, and a greater contribution to the field.