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Home/Legal & Regulatory and Reimbursement/$25 Million Offered for Novel Back Pain Research
Legal & Regulatory and Reimbursement

$25 Million Offered for Novel Back Pain Research

December 17, 2018 2 min read Premium comments

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$25 Million Offered for Novel Back Pain Research
Source: Wikimedia Commons and merzperson
Secondary#lowerbackpain#bacpac#chronicbackpain

A new U.S. Department of Health and Human Services (HHS) and National Institutes of Health (NIH) program called the Back Pain Consortium (BACPAC) Research Program, announced details December 10 of an offer of nearly $25 million in research grants under four programs in 2019, with more money over the next four years to grant winners.

Webinars on the grant programs, with question-and-answer periods, are set for these dates (posted December 13 on very short notice for the vital first one): December 19, 11 a.m. to 2:30 p.m. eastern time; January 15, noon to 2:30 p.m.; and January 23, noon to 2:30 p.m. Advance registration is mandatory to join the webinars, but webinar attendance is not required to apply for the grants. Webinar signup links and details: https://grants.nih.gov/grants/guide/notice-files/NOT-AR-19-031.html

Details on the Grants

RFA-AR-19-026: The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is offering $15.1 million in 2019 to start three to five “interdisciplinary Mechanistic Research Centers (MRC) in Low Back Pain (LBP).” These centers would “develop an integrated model of cLBP (chronic lower back pain), produce new and improved diagnostic and treatment algorithms, and test new therapies in Phase 2 clinical trials” in a five-year program. A letter of intent to submit is due by January 21, 2019; opening date for submissions is February 20, closing date March 20. Details: https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-026.html

RFA-AR-19-027:NIAMS is offering up to $6 million in 2019 to fund one or two awards for “Research Program Data Integration, Algorithm Development and Operations Management Center(s)” which would “guide and coordinate all activities of the consortium and ensure communications, interactions, synergies and accountability. It will manage a core as a Consortium-wide registry, including patient reported outcomes and preferences.” Application opening date and letter of intent to apply due date are both February 20, 2019; final due date for applications is March 20. Details: https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-027.html.

RFA-AR-19-028:“Technology Research Sites (Tech Sites)” to develop, test and deploy novel analytic tools, technologies and/or methods (TTM) to improve understanding of mechanisms of cLBP, seeking to create an integrated model of cLBP. First grant submission date and letter of intent due date are February 20, 2019; application deadline is March 20. Total awards: up to $2.6 million for four to six grants. Details: https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-028.html

RFA-AR-19-029:Clinical trials (CT) planning grants. “The goal of the Phase 2 CTs will be to test the safety and efficacy of non-addictive therapies for cLBP…. Innovative trial designs will be used to test new non-addictive drugs, biologics, devices and complementary medicine approaches to relieve pain and improve physical function,” the announcement says. NIAMS is offering $1.3 million for up to eight 2019 awards of no more than $200,000 each for the planning phase. After 2019, no more than five will be chosen to go forward for the next four years.

The 2019 planning phase under 029 is to be carried out in consultation with a program called the Early Phase Pain Investigation Clinical Network: EPPIC-Net (formerly known as the Clinical Trial Network for Pain Research, CTNPR). See the notice page for links to details on that other program. Letter of intent due date and first date for submitting applications are both January 26; final application deadline is February 26. Details: https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-029.html

BACPAC is part of the federal HEAL (Helping to End Addiction Long-term) Initiative, which seeks alternatives to opioids for pain.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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