Shawn Farrokhi, PT, DPT, PhD
Resolving the Burden of Low Back Pain in Military Service Members and Veterans (RESOLVE)
Shawn Farrokhi (SF): This project is near and dear to my heart because I became a clinician before I became a scientist, and the idea originated from my own experiences as a physical therapist (PT). Improving the quality of care for our patients is important to me and was the impetus behind writing this proposal. Low back pain is a serious issue in physical therapy and is one of the top diagnoses that PTs see—and more so within the military and VA settings, where it is consistently the number one diagnosis that we encounter.
Our focus within the trial is not the patient, but the provider—the physical therapist. Low back pain is extremely frustrating for patients and clinicians alike because often patients don’t get better and we, as care providers, often don’t know what’s causing their pain. In our efforts to get the patient better, we try different strategies to figure out what works best for that patient. The established clinical practice guidelines (CPGs) are one way to allow us to be a little bit more systematic in those efforts, using evidence-based interventions for our patients. Previous research into PT CPGs has shown that if providers adhere to the recommendations, patients have better outcomes—in general, and in terms of pain and function, and decreased use of opioids. They also need less future health care interventions, such as surgeries, injections, and other specialist visits outside of the PT setting. Yet, only about 40 to 45% of PTs adhere to the CPGs. This project is a strategy to improve adherence to the CPGs which that's about therapy environment.
In this trial, we're using an education, audit, and feedback strategy. We provide participating PTs with education on the use of CPGs, including psychologically informed PT (one of the main recommendations of the CPGs). The education comes in the form of continuing education courses that providers would take anyway in order to fulfill their licensing requirements. Once they receive the education, we audit their patient outcomes to see how well their patients are doing as compared to their colleagues and to everyone within the DOD or the VA that's a part of our trial. This gives the providers a point of reference as to their patients’ progress. We then provide the PTs with what percentage of their patients receive CPG-adherent care. If patients aren't getting better and the PT is not adhering to the CPGs, it's clear what needs to happen: PTs need to adhere to the clinical practice guidelines.
This feedback is provided to the PTs monthly and is anonymous, so they see only their own feedback about how well they are adhering to GPGs and how their patients are doing. Providers can see trends over time to see if making a change today means patient improvement in the coming months. We want everything we do to be very streamlined and something that could be easily implemented within the PT environment. Patients won't see any difference in terms of the care that they're receiving since they are all receiving the standard of care that their PT would usually provide and we don't have an experimental group per se, where a novel approach would affect the patient. This format has allowed us to have a large sample for our trial, with the goal of enrolling 3,500 to 7,000 individuals into the study.
SF: As a part of our trial, we created new educational modules because they didn't exist previously. There are a lot of different CPGs for managing low back pain from different associations. We focus more on American Physical Therapy Associations (APTA) recommendations because it's closer to how we practice and most PTs are more comfortable taking recommendations from the APTA (which published its own CPG in 2012 with an updated being released this year), as opposed to the recommendations that may come from other organizations that represent different providers, perspectives, and approaches to low back pain management. For instance, the Association of American Physicians and Surgeons will have different practice recommendations because its members can order treatments that we can't, such as prescribing medications. We've incorporated updated APTA CPGs within the educational modules to be consistent with the new recommendations that are coming out in November. We think providing education for PTs can remedy the fear and other barriers to engagement that lower utilization of active treatments, and psychologically-informed PT which is an important part of the APTA recommendations.
Patient education is important, but continuing education for providers is also an essential component of care that needs to be highlighted during initial practitioner education, when their practice is more flexible in accepting new skills—like active interviewing, which is one of the aspects our educational sessions address. Developing a therapeutic alliance with patients where the patient trusts the PT enough to talk about barriers to pain management, like the fear of moving or exercising. This is not a common skill that most PTs have, and it isn’t always easy to practice or insert the discussion in PT appointments. In our education sessions, we do a lot of role-playing to practice engaging a patient in talking about their fears, like, "I'm afraid of sleeping at night because my back pain wakes me multiple times." We have a clinical psychologist as a part of our educational team that helps us establish some of those paradigms and make them applicable in PT-patient interactions. We have clinicians that talk about graded exercise and graded exposure and other techniques that we use in terms of dealing with some of the psychosocial barriers to recovery.
SF: Psychological-informed PT incorporates behavioral issues into the hands-on or exercise-driven approach to treatment that we usually do as PTs. We want to give patients the tools that they need to take care of their own body and the incorporation of behavioral and psychological approaches into clinical practice allows patients to have a better understanding of how they can be in charge of their own care. Research shows that if you have low back pain, the more active you are and the more walking you do, the sooner you feel better, but a lot of patients develop a fear of movement, believing that if they exercise or move more, their condition will get worse. Through education, PTs can address psychological and behavioral aspects to help the patient understand some of the concepts associated with fear-avoidance behaviors. In psychologically-informed PT, a provider might implement an integrated treatment plan that includes graded exercise as a way exposing the patient to an activity that they're fearful of. For instance, the patient will be asked to walk one more minute each day, eventually building up to a goal that patient and provider set by working together.
SF: Physical therapists provide treatments in two different categories: active treatments (when the patient takes responsibility for the intervention, such as walking or other exercise) and passive treatments (when the physical therapist provides the intervention, such as ultrasound treatments or traction). A lot of research has looked at these two different treatment categories, and patients who take part in active treatments have much better short and long-term outcomes, as opposed to the patients that come in for just passive therapy where the PT performs all the work. One of the biggest recommendations in the CPGs from the American Physical Therapy Association (APTA), our PT flagship organization, is to utilize active treatments for PT patients. Another recommendation is for PTs to be more cognizant of psychosocial barriers to PT engagement, with one of the biggest being fear-avoidance.
For some of our established PTs, the barrier is needing a new perspective or having resistance to changing their practice because it takes time. People like the way they do things and when you’re a PT who is working with a high volume of patients, it's hard to do some of the practices you know you want or ought to do, like having a meaningful conversation with patients about their pain-related fears. Time is another limiting factor in terms of adherence to guidelines. When you only have 15 or 20 minutes with your patients and you need to put your hands on them and so some of the patient education aspect of our jobs falls to the wayside.
SF: Pain and function are the two primary outcomes that we usually look at in clinical trials, but we also have some secondary and tertiary outcomes that we're looking at, including medical care utilization and specialty referrals, related surgeries and injections, and the rate of opioid use in patients that receive CPG adherent care versus those that did not receive CPG adherent care for one year after they’ve finished their physical therapy. These outcomes are important because low back pain in the military is associated with high utilization of opioids and additional health care services, as well as duty time loss, and higher costs.
From an organizational perspective, the military health system (as well as the VA), has a vested interest in reducing the costs for managing low back pain. If we can come up with a strategy where all those downstream costs are lowered, that would really benefit one of our main stakeholders in the health systems within which we work. The third aim of our study is to look at the characteristics of our physical therapists—their training (including specialty training), age, and length of practice—to see if any of those characteristics have an influence on how they practice. From the perspective of another stakeholder—the physical therapy profession—we wanted to see what additional education and training we need to be paying attention to so that we can improve outcomes.
SF: Low back pain is extremely prevalent after an amputation, with an estimated 40- to 90-percent of those people who lose a limb experiencing low back pain. It is a multifaceted condition and there hasn't been a lot of research done in understanding how low back pain should be managed in this patient population. Body mechanics change after you lose a limb—you walk differently, you use your muscles differently, you negotiate your environment differently—but there are also psychosocial factors that come into play since you become more sedentary. Additionally, there are some reports of increased depression, anxiety, and fear of movement. All of these events can contribute to the experience of low back pain in this patient population. While we wrote the PMC study proposal to look at low back pain in general, we have a very focused subgroup analysis with our study of looking at patients with amputation to see how they benefit from physical therapy care for low back pain.
SF: Traditionally physical therapy has been a face-to-face type of interaction between a patient and a physical therapist, but over the last year and a half, the pandemic has influenced greater use of virtual visits and virtual care, making them more commonplace. We couldn’t count on doing our usual hands-on practice for patients during the pandemic, so we incorporated looking at the percentage of virtual versus in-person visits in our trial. COVID also has had some influence on our participating clinics to varying degrees, depending on their geographic location. There is a huge discrepancy between the sites in terms of how they're providing care, and that's something that we'll statistically look at to see if it has any influence on the outcomes of our trial. For instance, Florida has been really struggling with COVID cases recently, so there likely will be policy decisions to treat patients virtually more often than in person, but here in San Diego, we're doing pretty well. Also, we had planned to have face-to-face training for our continuing education sessions for PTs, but we've transitioned all of our training into synchronous modules provided virtually.
SF: It’s been a really positive experience to be in the same virtual room with a lot of great minds. We all have a common goal— to improve pain management and, more specifically, to improve pain management within the VA and military settings. I've learned a lot just being a part of this community. Some of the leaders in psychologically-informed PT and low back pain management are a part of PMC3, and to have the opportunity to pick their brain and hear about their ideas in real-time has been extremely fulfilling from a personal standpoint. It’s also given me the opportunity to share some of my opinions and feel like I’ve contributed to the advancement of knowledge in this realm. It's been a joy working with all the folks who manage the PMC3, as well as all the PIs who contributed to discussions on a regular basis.
Working Documents & Other Information
Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Multi-Site Pragmatic Clinical Trial (RESOLVE Trial)
This multi-site PCT will compare an active CPG implementation model...Read More