January 18, 2022: Documentation Available From Ethics and Regulatory Consultation With IMPACt-LBP NIH Collaboratory Trial

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Meeting minutes and supplementary materials summarizing a recent discussion of ethics and regulatory issues associated with the new IMPACt-LBP NIH Collaboratory Trial are now available. The consultation took place by video conference and included representation from the study’s principal investigators and project manager, members of the NIH Collaboratory’s Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.

IMPACt-LBP is a 2-arm cluster randomized trial that will evaluate the effect of first-contact patient referral to physical therapists and doctors of chiropractic for patients with low back pain. The study aims to determine if initial contact with these clinicians will improve physical function and decrease pain, among other outcomes, in patients with a primary complaint of low back pain, when compared with usual medical care. Read more about IMPACt-LBP.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

October 21, 2021: NIH Collaboratory Launches IMPACt-LBP NIH Collaboratory Trial

IMPACt-LBP investigatorsThe NIH Collaboratory is excited to announce the addition of a new large-scale pragmatic clinical trial to its portfolio: Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt‑LBP). Co-led by investigators at the Duke Clinical Research Institute, IMPACt-LBP is a pragmatic, multisite, 2-arm cluster randomized trial that will evaluate the effect of a multidisciplinary collaborative team approach for low back pain (LBP) versus usual care. In the intervention arm, patients with a primary complaint of LBP will be referred to physical therapists and chiropractic doctors—or primary spine practitioners (PSPs)—as first-line providers.

This study aims to determine if initial contact with PSP clinicians will improve physical function, decrease pain, decrease opioid prescriptions, improve patient satisfaction, and decrease costs and utilization of health care services in patients with a primary complaint of LBP, when compared with usual medical care.

NIH Collaboratory Trials are multicenter, pragmatic trials that are embedded in healthcare delivery systems to gather real-world evidence and answer clinical questions of major public health importance. In its first 10 years, the NIH Collaboratory successfully engaged with 21 complex NIH Collaboratory Trials. IMPACt-LBP will join 6 other NIH Collaboratory Trials that focus on pain as part of a broader effort to reduce opioid prescribing and inform policy.

The results from this study will directly inform implementation and policy efforts to improve the quality of pain management for patients suffering from LBP while simultaneously reducing opioid prescriptions, health care costs and utilization of services.

The study is supported within the NIH Collaboratory by the National Center for Complementary and Integrative Health, with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development.