Fritz, J. M., Magel, J. S., McFadden, M., Asche, C., Thackeray, A., Meier, W., & Brennan, G. (2015). JAMA, 314(14), 1459-1467.

Abstracted by: Heather O’Dell SPT, Missouri State University, Springfield, Missouri

This study included 220 participants with acute low back pain (LBP) meeting criteria previously defined as a clinically predicted to benefit from spinal manipulation, including: Oswestry Disability Index (ODI) score ≥ 20, current symptom duration < 16 days, and no symptoms distal to knees within 72 hours. All participants received patient education following baseline assessment including review of provided materials, benefits of physical activity for LBP, and positive prognosis outcomes for LBP. The physical therapy care group was seen for four visits across three weeks, including assessment during initial visit, while the usual care (control) group received no interventions after initial patient education. Physical therapy intervention included high-velocity, low-amplitude thrust (HVLA) manipulation to the lumbar spine during the first two visits. The first visit also included spinal ROM exercises; the second visit (2-3 days after initial visit) included ROM exercise review and addition of primary lumbar stabilization exercises. The third and fourth visits (each at one-week intervals after visit 2) included review of all previous exercises and progression as appropriate.

The primary outcome measure, ODI at 3-month follow-up, was statistically significant between the PT group and the usual care group, with the PT group improving -3.2 points more than the usual care group (lower ODI score indicates less disability); however, this difference does not meet clinically significant criteria for the ODI (6-point difference). Secondary outcomes were also statistically significantly improved for the PT group at 4-week and 3-month follow-up, including pain rating and patient-reported success. However, at 1-year follow-up, there were no significant differences in outcomes between those receiving early intervention with physical therapy and those receiving only the educational component (usual care).

The authors note that the 4-session physical therapy intervention utilized in this protocol is practical for clinical use and is shorter than the typical episode of care of 7 sessions. However, with no differences at 1-year follow-up and with data asserting that patients with acute LBP should be allowed to spontaneously heal, further research may be needed to assert that claim. Also, there is evidence that those patients not referred to PT or whose PT referral is delayed 2-4 weeks after original assessment may be at greater risk for invasive procedures, opioid prescription, or early use of imaging techniques, which increases healthcare utilization and cost and decreases quality of care as these methods are in conflict with current clinical guidelines.

In conclusion, this study shows that early PT intervention leads to statistically significant improvement in functional outcomes compared to usual care, but not clinically significant change, and differences between groups are not carried over to 1-year follow-up.

Personal Commentary:

I found this article very interesting, because I have a bias toward physical therapy and am still naïve enough in my career to believe that physical therapy is always beneficial. However, there are patients who are not appropriate for skilled physical therapy, and PT doesn’t “fix” everyone. That being said, I was still a bit discouraged that at 1-year follow-up, patients in early PT and those in usual care (control) did not show statistically significant differences in outcome measures. Regardless, I don’t think Dr. Fritz would advocate that no patients with low back pain would benefit from early PT intervention after reading some of the research related to low back pain treatment that she and her colleagues have produced.

I think one of the contributing factors to lack of significant change after one year was that in this protocol, patients were given a book to read with “messages consistent with LBP guidelines” and then the book was reviewed with a member of the research team. The study did not indicate how many patients reported reading the book, and after the initial session of book review and education on positive outcomes with low back pain and the importance of physical activity, there was no other education provided. The patients were not provided with information on lifting mechanics, ergonomics, or proper sitting posture during the study. The authors noted that their educational approach was “likely beyond what typically occurs,” (Fritz et al., 2015) but Gellhorn, Chan, Martin, & Friedly (2012) assert that physical therapists are likely to provide education throughout an episode of care on a range of topics related to low back pain and patients’ questions.

Another adherence issue could be to the home exercise program. Within two visits in the first week, patients were given ROM exercises (number of total exercises not specified) and instructed to complete 10 repetitions x 3-4 sets “throughout the day,” (Fritz et al., 2015). Compliance to session attendance is noted in the study, but HEP compliance is not, though that would likely have been data reported by the patient and therefore may not have been accurate. There is another case to be made here for patient education in that these patients may have stopped being active and/or performing these exercises targeted to low back pain treatment after the end of their 4-visit episode of care. The authors also note that they progressed patients’ interventions but did not note the progression used for lumbar stabilization exercises.

In this study, there were also not statistically significant differences in healthcare utilization outcomes at 1-year follow-up. The authors collected data for emergency room/urgent care visits, advanced imaging, spine specialist visit, spine injection, and spine surgery. There is argument that without early PT intervention, patients are at higher risk for more invasive or even guideline-contraindicated treatments, such as injection, surgery, opioid prescription, etc. (Fritz et al., 2015; Fritz, Childs, Wainner, & Flynn, 2012). Fritz et al. (2015) suggested that at 1-year follow-up, there was no difference in these outcomes between groups; however, Childs et al. (2015) demonstrated that at 2-year follow-up, patients who received early PT accumulated a 60% less cost of care for their low back pain than those with physical therapy referrals that were later in their episode of care. This cost was not compared to those who did not receive PT (Childs et al., 2015). There are also assertions that later referral to PT may be preferred because low back pain should be given the chance to spontaneously heal (Fritz et al., 2015; Gellhorn et al., 2012) and PT referral should be delayed 7 weeks to allow this process, if it occurs at all. However, PT literature asserts that back pain can be recurrent, that an acute episode can reappear and then can recur repeatedly and cause more problems throughout the lifespan, implying that physical therapy is needed to reduce the likelihood of these recurrences (Gellhorn et al., 2012).

In my experiences during clinical rotations, patients dealing with low back pain have many other factors contributing to their pain and lack of function. Patients hear the word “disc” or “back problem” or “spine” and tend to automatically catastrophize and assume that they are going to need surgery. Providing education to these patients to calm their fears and teach them about outcomes in low back pain can be an incredibly valuable tool, and was used by Fritz et al. (2015) in this study. Patients with low back pain are each unique in their need for interventions and intensity of care. While I greatly appreciate Dr. Fritz’s and her colleagues’ contributions to physical therapy and the wealth of knowledge and research they have shared with us, I also have to read this research through the scope of a future clinician. Physical therapy treatment has to be individualized, and it isn’t in research studies; the standard protocol applied to all participants, while adherent to clinical practice guidelines in this study, may not be the absolute best option – some may have needed more exercise interventions, some may have needed more manual, or any other combination of interventions provided.

In my practice, what I want to take away from this research is to continue to advocate for my patients and to be an expert in my practice. I need to be able to recommend skilled services as appropriate and to make my case with knowledge, clinical experience, and scientific evidence. The science shows us that recurrent back pain is a problem, and that not every patient has an acute issue that can show vast improvement in 4 visits. Science also shows us how to best move the discs and the joints and the nerves that could all be contributing to a patient’s pain. We also have research on the benefits of early PT intervention and that it has been shown to improve outcomes decrease subsequent cost and healthcare utilization (Childs et al., 2015; Fritz et al., 2012; Fritz et al., 2015). As healthcare legislation continues to change and evolve and CMS moves into outcomes-based payment, it will become even more important to advocate for skilled therapy services based on the benefits PT can provide to patients long-term; also, as direct access continues to become more widespread and potentially implemented by CMS and private insurance companies, PT can become an important primary care provider and early intervention method for patients with low back pain.

References:

Childs, J. D., Fritz, J. M., Wu, S. S., Flynn, T. W., Wainner, R. S., Robertson, E. K., . . . George, S. Z. (2015). Implications of early and guideline adherent physical therapy for low back pain on utilization and costs. BMC Health Services Research, 15(150). doi:10.1186/s12913-015-0830-3
Fritz, J. M., Childs, J. D., Wainner, R. S., & Flynn, T. W. (2012). Primary care referral of patients with low back pain to physical therapy: Impact on future health care utilization and costs. Spine, 37(25), 2114-2121.
Fritz, J. M., Magel, J. S., McFadden, M., Asche, C., Thackeray, A., Meier, W., & Brennan, G. (2015). Early physical therapy vs usual care in patients with recent-onset low back pain: A randomized clinical trial. JAMA, 314(14), 1459-1467.
Gellhorn, A. C., Chan, L., Martin, B., & Friedly, J. (2012). Management patterns in acute low back pain. Spine, 37(9), 775-782. doi:10.1097/BRS.0b013e181d79a09

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