Funded Projects

NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
NOFO Number: RFA-AR-19-028
Summary:

This project will examine the association between end plate pathology and chronic low back pain (cLBP) and improve patient selection by developing and translating new imaging tools, technologies, and/or methods (iTTM) that provide accurate, noninvasive measures of end plate pathologies. A search for clinically relevant biomarkers of end plate pathology will focus on novel imaging measures of end plate bone marrow lesion (BML) severity with IDEAL MRI and cartilage endplate (CEP) fibrosis/damage with UTE MRI, assess interactions with paraspinal muscles, and identify metrics that associate with pain, disability, and degeneration. The research will refine imaging and post-processing methodologies by leveraging and expanding existing cross-sectional cohorts and then deploy and validate the new end plate iTTM to other BACPAC sites to test the most promising metrics’ clinical utility. These studies will provide validated iTTM that are useful for addressing the end plates pathology’s role in cLBP, identifying sub-phenotypes, discovering pain mechanisms, uncovering treatment targets, and selecting patients.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Promote Training in Clinical Research on Pain (Admin Supp ? Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-044
Summary:

It is increasingly clear that the microbiome influences psychoneurological symptoms, including pain. This project will support clinical research training focused on examining the relationship between the composition and function of the gut microbiome, including the symbiotic bacteria residing in the gut and their functional gene content, and chronic pain among adults with end-stage kidney disease (ESKD). It provides an opportunity for the trainee to expand his skill set as a pain investigator, through experience in implementing and evaluating pain management interventions in adults with ESKD and chronic pain receiving maintenance hemodialysis. The project aims to determine the acceptability of collecting feces and the feasibility of fecal data collection procedure to determine the best strategies for recruiting research participants from multiple dialysis facilities. These steps will allow the exploration of gene content of the gut microbiota and short-chain fatty acids among people with ESKD on maintenance hemodialysis before and after pain management interventions.

NOFO Title: HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trials Optional)
NOFO Number: RFA-AT-20-004
Summary:

Back pain is the most common chronic pain diagnosis and the most common diagnosis for which opioids are prescribed. Clinical practice guidelines make it clear that nonpharmacologic treatments are preferable to opioids for patients with back pain. Despite clear evidence, over-prescribing of opioids to individuals with back pain continues. Providers of nonpharmacologic care are often absent or unreachable from rural and low-income communities and patients with limited financial resources. Many rural and low-income communities are served by Federally Qualified Health Centers (FQHCs) that are at the forefront of the opioid crisis, but often lack adequate options to provide accessible nonpharmacologic treatments. This pragmatic clinical trial will compare the effectiveness of different telehealth strategies to provide effective nonpharmacologic interventions to overcome the barriers specific to serving rural and low-income communities. The trial will evaluate two strategies, one providing both a brief pain teleconsult with phone-based physical therapy, the other uses an adaptive strategy ? providing the brief pain teleconsult first, followed by phone-based physical therapy to those who need additional treatment. The study will also evaluate outcomes related to the efforts to implement strategies in FQHC clinics. This research will provide a toolkit for future efforts to make nonpharmacological interventions for back pain available in other low resource health care settings.

NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) (R01 Clinical Trial Required)
NOFO Number: RFA-DA-23-041
Summary:

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. This project will compare a patient-centered tapering protocol with or without MORE in primary care offices in New Jersey and Utah. The MORE approach integrates training in mindfulness, reappraisal, and savoring to alter behavior away from valuation of drug rewards and toward natural rewards. This research will also identify practices to use MORE in primary care settings.

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002
Summary:

Clinician bias causes inequities in healthcare, and interventions are needed to mitigate and eradicate this bias. This project aims to develop and test the impact of two interventions on overcoming clinician implicit bias in the management of pain for children from ethnic minorities treated in the emergency department. The study will include pediatric patients from under-represented minority groups with pain from long-bone fractures or acute appendicitis who are cared for by racially and ethnically diverse caregivers. Researchers will use stakeholder-informed approaches to establish quality of care metrics and then use clinician audit and feedback as well as data from electronic health records to quantify evidence of bias.      

NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) (R01 Clinical Trial Required)
NOFO Number: RFA-DA-23-041
Summary:

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. Continued, long-term use of opioids after surgery by individuals who use opioids increases the risk of postoperative complications, opioid use disorder, and death. Surgery is a critical point-of-care moment for health care providers to interact with patients who use opioids about continued opioid use when harms outweigh benefits. This project will test of the Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) strategy, with or without a medication that reduces anxiety and relieves pain, at four geographically diverse hospitals across the nation.

NOFO Title: Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs)(U24)
NOFO Number: RFA-TR-15-004

NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-19-036

NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management
NOFO Number: RFA-AT-22-003
Summary:

Pain in muscles and surrounding connective tissue (myofascial pain) is a significant health concern affecting hundreds of millions of Americans. There is no objective way to identify and measure myofascial pain. This project will address this unmet challenge by developing a robust approach to identify imaging biomarker(s) that can distinguish different states of myofascial pain. The research will then examine the ability of identified biomarker(s) to predict patient responses to a myofascial pain treatment in a randomized controlled clinical trial.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
NOFO Number: NOT-OD-20-101
Summary:

Medications have proven to be effective for treating opioid use disorder (OUD). Increasing accessibility to buprenorphine provides an opportunity for many with OUD to benefit from its proven effectiveness. Adherence to medication-based treatments however is low, in part because of the stigma associated with use of this and other effective drugs and as such, leads to inadequate treatment and poor outcomes. This study aims to understand the effects of stigma on patient engagement, retention, and outcomes of buprenorphine treatment. Knowledge drawn from the HIV Stigma Theory and tools developed to reduce HIV associated stigma will be used to assess OUD stigma and to develop interventions to reduce it in the context of buprenorphine treatment. The study findings may provide resources to address stigma and thus maximize treatment adherence among those affected by OUD.

NOFO Title: HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)
NOFO Number: RFA-DK-18-030
Summary:

Despite the pervasive use of opioid analgesics in the dialysis population and the substantial risks they engender, their efficacy is limited in treating common chronic pain conditions. Most patients receiving long-term opioid therapy continue to experience severe pain and functional limitations. To simultaneously address problems related to chronic pain and opioid use in the U.S. hemodialysis population, this study will evaluate tailored patient-centered interventions to manage pain and reduce opioid use. Patients will be assigned randomly to one of three groups over a 12-month study period: 1) pain care management (PCM) versus 2) PCM plus an online pain self-management program (PSM) that incorporates cognitive behavioral training and is delivered during dialysis sessions, versus 3) control with medication review and education. The study will also evaluate the effectiveness of offering buprenorphine by randomly assigning participants in both active treatment arms to being offered buprenorphine rotation versus continued standard opioid taper support without the option of buprenorphine.

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002
Summary:

Both pain experience and treatment response are determined by a variety of factors, including race and ethnicity. Inequities in access to healthcare and pain treatment affect patients from minority populations, such as Hispanic/Latino populations of all age groups. This study will develop and test an online intervention—Web-based Tailored Intervention for Preparation of Parents and Children for Outpatient Surgery (L-WebTIPS)—tailored for Latino families of children having outpatient surgeries. The intervention aims to lower child and family anxiety before surgery as well as to reduce post-surgical pain by enhancing parent self-efficacy and behavioral pain coping strategies. After an exploratory phase to assess usability and acceptability of the intervention, the study will evaluate the impact of L-WebTIPS on child pre-surgery anxiety and post-surgery pain as well assess other child and parent outcomes.

NOFO Title: HEAL Initiative: Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-22-050
Summary:

Chronic low back pain affects millions of people in the United States, resulting in high medical costs and lost productivity. New opioid-free treatments are needed to help people with chronic low back pain, but not all people respond equally to a given approach. IMPACT aims to use machine learning to analyze data such as physical activity, sleep, emotions, and pain levels and identify markers that can help predict how effective a mindfulness-based treatment approach (Mindfulness-Based Stress Reduction) can be for people with chronic low back pain.