Research Initiative Highlights

PCORI seeks to fund large, pragmatic, randomized clinical trials (RCTs) that compare the effectiveness of sequences of efficacious and/or commonly used noninvasive interventions alone or in combination for patients with nonspecific, nonradicular chronic low back pain.

The definition of this condition has not always been consistent: while chronic low back pain has been generally described in clinical practice guidelines as pain that persists for 12 weeks or longer, the National Institutes of Health Task Force on Research Standards for Chronic Low Back Pain has defined it as pain that is present on at least 50 percent of days during a six-month period. Either of these definitions is acceptable in a proposal with a strong rationale and justification for why it was chosen and how it will be operationalized. Nonspecific chronic low back pain must be unaccompanied by pain or neurological symptoms and signs in the lower legs, and without abnormalities on imaging tests other than degenerative disc disease. This population includes those individuals who have progressed from a period of intermittent episodes of low back pain to the state of persistent pain meeting one of the two definitions. We are particularly interested in large pragmatic studies that can investigate potential heterogeneity of treatment effects among important patient subgroups (e.g., overweight or obese patients, patients with prominent psychosocial stressors or comorbid mental health conditions, older adults, patients who smoke cigarettes, or other subgroups proposed by investigators with an accompanying strong rationale.) Investigators are encouraged to consult the minimal dataset requirements of the NIH Task Force on Research Standards for Chronic Low Back Pain when planning participant recruitment and data collection, including potential subgroups.

PCORI is interested in comparing sequences of interventions with adequate evidence of efficacy and/or that are in common use. Applicants should provide systematically reviewed evidence or other convincing documentation that the proposed comparative treatments have been shown to have clinically meaningful effects on objective measures of function. If applicants propose comparing interventions that are in common use but without clear evidence of efficacy, they must document the extensiveness of their use and demonstrate how they will interpret comparative results. Based on a 2016 AHRQ systematic review by Chou et al., interventions of interest may include but are not limited to the following:

• Active physical therapy modalities (e.g., exercise therapy)
• Complementary and integrative health (e.g., acupuncture)
• Non-opioid pharmacologic interventions (e.g., NSAIDs, duloxetine)
• Multidisciplinary/interdisciplinary rehabilitation interventions (e.g., having both behavioral and physical components)

Proposed comparators must be adequately operationalized and the proposed operationalization must align with available evidence of efficacy. Proposed sequences of interventions must address actual clinical choices faced by patients, caregivers, and clinicians in specific practice settings.

In addition to including pain and function, applicants are strongly encouraged to include well-validated outcome measures from at least the following domains: quality of life, productivity and return to work/return to premorbid function, and healthcare utilization. Studies should conduct periodic outcome assessment, including outcome assessment after a follow-up period of 12 months or longer.

A preannouncement was provided to allow potential applicants additional time to identify collaborators, obtain stakeholder input on research questions, and develop responsive, high-quality proposals.