Study Spotlight: TARGET Trial

Anthony Delitto, PhD, PT, FAPTA, of the University of Pittsburgh and UPMC, leads the TARGET Trial.

Many people are all too familiar with low back pain. It’s a common problem among adults that can impact a person’s ability to participate in daily activities, including their job. Though many experience acute discomfort every once in a while, for some this progresses to persistent pain. The TARGET Trial, led by Dr. Anthony Delitto of University of Pittsburgh and UPMC, and Dr. Robert Saper of Boston University and Boston Medical Center, hopes to reduce the proportion of patients who progress from acute to chronic low back pain, or LBP.

The TARGET Trial, which is the first PaTH-affiliated study to receive funding, will compare two treatment options for patients with acute LBP. The first approach will inform primary care physicians (PCPs) of a patient’s risk of progressing from acute to persistent LBP and will encourage PCPs to treat patients according to accepted clinical guidelines. The second approach will provide the same risk information but will also have PCPs work with physical therapists to deliver psychologically-informed physical therapy for those patients who are at high risk for developing persistent LBP.

Robert Saper, MD, MPH, of Boston Medical Center and Boston University, is co-principal investigator of the TARGET Trial.

Like standard physical therapy, psychologically-informed physical therapy works to improve a patient’s physical function through specific stretching, strengthening, and aerobic exercises. However, it also has the added element of addressing the psychosocial obstacles that may hinder a patient’s recovery. These obstacles include fear avoidance behaviors, in which a person avoids treating pain because it hurts but in doing so allows the pain to progress, and catastrophizing, or believing a situation is far worse than it is. For the TARGET Trial, physical therapists will use education, coaching, and graded exercises to help patients overcome these psychological obstacles while also improving physical function.

Courses on psychologically-informed physical therapy will be held at all sites participating in the TARGET Trial: UPMC, Intermountain Healthcare, Boston Medical Center, Johns Hopkins Medicine, and the Medical University of South Carolina (MUSC). Physical therapists trained in the techniques will also receive a checklist to refer to when administering care with items such as pain coping skills and communication guidelines.

Researchers will follow up with patients by email or phone after six and 12 months to determine whether their acute LBP has become persistent LBP and to assess their functional ability. In addition, researchers will use data pulled from PaTH’s Common Data Model to compare the two treatment options in terms of LBP-related use of medical resources including PCP visits, referrals to specialists, imaging, prescription analgesics, hospitalizations, and surgical procedures.

Researchers have started enrolling patients from UPMC and Intermountain Healthcare. Boston Medical Center will begin enrollment in December, while Johns Hopkins Medicine and MUSC will start enrolling in 2017. There are currently 1,264 participants enrolled in the Quality Improvement component of the study, which consists of a patient’s baseline visit to their PCP, responses to screening questionnaires, and a functional assessment. The research component consists of the six- and 12-month assessments of the patient’s functional ability and their pain status as acute or chronic, coupled with a review of their electronic medical record and claims data for LBP-related resource use during the 12-month period. The six-month assessments will start at UPMC in November. Researchers expect to enroll 12,000 patients in the Quality Improvement component and 9,840 in the research component’s six-month assessment.

Dr. Delitto says he is most excited about the pragmatic nature of the TARGET Trial because it has allowed researchers to "implement state-of-the-art assessment tools" that can identify patients at risk for chronic pain and immediately refer them to psychologically-informed physical therapists.

"The approach has worked in European countries and, if replicated in the TARGET Trial, the high degree of generalizability of our study allows for more immediate implementation in the U.S.," he says.

The TARGET Trial is a national study funded by PCORI (the Patient-Centered Outcomes Research Institute), which has invested over $12 million in the trial.

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