Background
Low back pain (LBP) is highly prevalent. LBP is the most common type of pain and the second most common reason for doctor visits in the United States. The prognosis of acute LBP is generally considered good, with a prevailing view that spontaneous recovery occurs within six weeks. However, epidemiologic studies in primary care settings report that only 60-75% of patients are improved, 30% have no change, and 14% are worse after one month.
LBP is associated with limitations in physical function, work, and school activities. It can impact the ability and desire to engage in social activities, resulting in social isolation, marital conflict, and feelings of resentment and dejection in friends or family members. Furthermore, LBP results in high medical utilization. Annual direct costs for LBP care in the US are more than $50 billion. Opioid prescribing for LBP is increasing and contributing to the national opioid abuse problem. LBP disproportionately impacts racial and ethnic minorities. Research shows that minorities with LBP receive less patient education, analgesic prescriptions, back surgery, specialty referrals, and intensive rehabilitation for LBP.
Gaps in Current Evidence
A lot of research has been done on prevalence and treatment of LBP, but there are still major knowledge gaps.
- How many patients will develop chronic LBP? Despite numerous studies documenting epidemiology, there is little discrete information about chronic LBP and its relationship to acute LBP. Estimated rates of transition from acute to chronic LBP vary widely from 5-33% of patients.
- What is "chronic" LBP? A contributor to the lack of strategies to prevent chronic LBP and characterization of chronic LBP is the lack of definition of chronic LBP, ranging from 7-12 weeks. However, the NIH Task Force on Research Standards for Chronic Low-Back Pain addressed this issue in their 2013 report.
- How effective are clinical practice guidelines? Patient preferences do not always align with LBP treatment guidelines. Patients often want an explanation for their symptoms and can understandably become impatient with “wait and see” approaches, which are common in guideline recommendations. Furthermore, time constraints common to PCP practices in the US can be a major barrier in addressing patient concerns.
Rationale
Research carried out in European countries has demonstrated that a stratified approach using prognostic screening tools to assess both physical and psychosocial factors, coupled with matched intervention pathways, can have important implications for better managing acute LBP in primary care settings. A stratified approach helps to identify patients who may benefit from increased education and attention due to greater perceived pain, poor physical functioning, maladaptive coping behaviors (catastrophizing, fear avoidance), and comorbid depression and/or anxiety. A study conducted in UK family practices used a screening tool (STarT Back) to stratify acute LBP patients into 3 risk categories: high, medium, low (Foster, et al.). Those patients determined by the STarT Back tool as being high risk had higher levels of fear avoidance, catastrophizing, mood disturbance, and perceived pain. Though the stratified approach with targeted intervention is beginning to be evaluated in the US, published studies based in US healthcare systems have thus far been limited in scope, observational in nature, and have not prospectively measured the transition from acute to chronic LBP.
From the provider perspective, the proposed study attempts to demonstrate which option is most efficient in getting targeted care to high risk patients: (1) an approach whereby higher risk patients are identified and the primary care provider determines options to direct targeted care to patients or (2) a more interprofessional team approach where providers refer to and collaborate with physical therapists to deliver evidence-based physical therapy augmented with cognitive behavioral coaching.
Significance
The TARGET Trial will assess whether a psychologically-informed physical therapy approach matched to patients at high risk for poor outcomes is effective in the US, has the potential to prevent patients with acute LBP from transitioning to chronic LBP, and reduces patient exposure to unnecessary, expensive, and potentially harmful tests, medications, and procedures. The observational cohort will yield descriptive information for the low to medium risk groups regarding transition to chronic pain, change in functional ability, and resource utilization for geographically diverse populations, differing healthcare settings, urban and rural catchment areas, and the underserved.