Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Project Title Research Focus Area Research Program Administering IC Sort descending Institution(s) Investigator(s) Location(s) Year Awarded
1R01HL150566-01
Arousal circuitry and opiate-associated memories New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Stanford University DE LECEA, LUIS (contact); CHEN, XIAOKE Stanford, CA 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Repetitive drug use forms powerful memories associating drug-evoked experiences with its proximal environmental cues. Memories are major obstacles for successfully treating addiction, since even after a prolonged period of abstinence, reexposure to such cues often triggers craving that promotes relapse. A polysynaptic pathway from the paraventricular nucleus of the thalamus (PVT) to the lateral hypothalamus (LH) has been shown to play a role in the maintenance of the opioid-associated memories. Hypocretin (Hcrt) neurons in the LH strongly innervate the PVT, required for maintaining wakefulness and involved in drug seeking. These factors may link sleep disorders in opioid addicts with their long-lasting drug-associated memories. This study will (1) determine whether Hcrt neurons in the LH are the major target; (2) examine whether manipulating the LH (Hcrt)-PVT pathway can effectively prevent relapse; and (3) test whether sleep intervention could be an effective strategy to prevent relapse.

3U01HL117664-05S2
CANNABINOID-BASED THERAPY AND APPROACHES TO QUANTIFY PAIN IN SICKLE CELL DISEASE Clinical Research in Pain Management NHLBI University of Minnesota GUPTA, KALPNA MINNEAPOLIS, MN 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Sickle cell disease (SCD) is an inherited hematologic disorder accompanied by severe pain, inflammation, and vascular injury. We propose that nociceptor activation by ongoing hypoxia/reperfusion (H/R) injury leads to the release of neuropeptides by sensory nerves in the skin, stimulating vascular insult and mast cell activation in SCD. In turn, mast cell tryptase activates protease-activated receptor 2 on sensory nerve endings, resulting in exaggerated neuroinflammation, vascular injury, and central sensitization. Our general hypothesis is that neurogenic inflammation contributes to pain in SCD and that cannabinoids provide analgesia by disrupting neurogenic inflammation and nociceptor sensitization. We also hypothesize that EEG and functional MRI can be used to optimize analgesic treatments in SCD. We propose to use transgenic sickle mice, and individual cells involved in evoking pain, to perform this translational study. A proof of principle study in humans will examine the effect of cannabis on pain in sickle patients.

1R43HL167661-01A1
Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions Cross-Cutting Research Small Business Programs NHLBI OPALGENIX, INC. PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR Carmel, IN 2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Thoracic (chest) surgeries often cause both short-term (acute) and long-term (chronic) pain and long-term opioid use. Unique genetic and clinical risk factors affect individual responses to surgical pain and pain medications. Current trial-and-error approaches to managing post-surgical pain and opioid prescribing are not ideal. This project will develop predictive software within a medical device that takes into account an individual’s genetic and clinical information to predict the likelihood of chronic pain following thoracic surgery. 

1R21AG082345-01
Assessing Chronic Pain Using Brain Entropy Mapping Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIA UNIVERSITY OF MARYLAND, BALTIMORE WANG, ZE Baltimore, MD 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Chronic pain affects millions of Americans and remains poorly understood and challenging to manage. Researchers do not fully understand brain processes involved in chronic pain, which can vary considerably from person to person. This project will analyze brain function using magnetic resonance imaging (MRI) in individuals with and without chronic pain. The research will also directly determine the degree of pain-related brain imaging changes by using a large database of brain imaging data.

1R61AG081034-01
Addressing the Chronic Pain Epidemic among Older Adults in Underserved Community Center; The GetActive+ Study Clinical Research in Pain Management Advancing Health Equity in Pain Management NIA Massachusetts General Hospital VRANCEANU, ANA-MARIA (contact); RITCHIE, CHRISTINE S Boston, MA 2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002
Summary:

This research project will include focus group interviews with clinicians, patients, medical interpreters, and healthcare administrators to identify barriers and facilitators to administering the GetActive+ intervention in a group visit at a clinic for older adults with chronic pain, to inform development of a therapy manual. The project will then test the GetActive+ intervention for changes in physical function immediately post-intervention and after 6 months, as well as for changes in pain, sleep, depression, and anxiety at both time points. This research will also assess feasibility, acceptability, fidelity, and adoption of the intervention with patients, providers, and healthcare staff. 

1UG3AG067493-01
Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIA KAISER FOUNDATION RESEARCH INSTITUTE DEBAR, LYNN L Oakland, CA 2019
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021
Summary:

To enhance availability of cognitive behavioral therapy for chronic pain (CBT-CP), this study will 1) refine strategies to identify and recruit patients, finalize intervention procedures, and ensure data infrastructure and quality; 2) determine the effectiveness of online and telephonic CBT-CP on patients and pain severity and secondary outcomes, including depression, sleep, quality of life, and pain-related health care utilization, from the electronic health record; and 3) assess the cost and incremental cost-effectiveness of online and telephonic CBT-CP compared with usual care. Eligible participants will be randomized to one of two painTRAINER interventions or usual care. Interventions will be eight weekly 45-minute sessions of the online program or telehealth-style phone coaching by trained behavioral health specialists. Self-reported pain severity and secondary outcomes will be assessed at baseline and at three, six, and 12 months.

3R61AG081034-01S1
Addressing the Chronic Pain Epidemic Among Older Adults in Underserved Community Center: The GetActive+ Study (McDermott-Career Enhancement Supplement) Clinical Research in Pain Management Advancing Health Equity in Pain Management NIA MASSACHUSETTS GENERAL HOSPITAL VRANCEANU, ANA-MARIA (contact); RITCHIE, CHRISTINE S Boston, MA 2023
NOFO Title: Notice of Special Interest (NOSI): Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain
NOFO Number: NOT-NS-22-087
Summary:

This project supports a post-doctoral trainee to develop the skills and knowledge needed to pursue a career in clinical pain research. The research will involve optimizing a GetActive mind-body activity program to overcome barriers that prevent disadvantaged older adult populations in community health clinics from access to non-pharmacological pain management strategies. The research will include qualitative analysis of secondary data, a literature review to evaluate methods, and feasibility for establishing a community advisory board for the GetActive project.

1R21AG082344-01
Using Secondary Analyses to Test Novel Pathways Linking Family Stress and Pain Incidence and Persistence Among African Americans Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIA UT SOUTHWESTERN MEDICAL CENTER WOODS, SARAH B Dallas, TX 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Managementin Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Chronic pain is a persistent source of disability and reduced quality of life for aging adults. Chronic pain-related outcomes are disproportionately worse for aging African Americans, who report greater pain severity and worse pain-related disability compared to White peers. A significant pain risk factor for African Americans is chronic stress (including family-related stress), which is worsened by structural inequities that affect this population. Although many African Americans identify family support as critical for pain self-management, this influence has not been studied thoroughly. This project will study how pain conditions develop and persist for aging African Americans by analyzing existing data from African American participants in two large aging studies: Midlife in the U.S. (721 participants) and the Health and Retirement Study (2,698 participants). The research aims to determine how family emotional climate affects pain risk, taking into account structural factors like discrimination, socioeconomic disparity, and the influence of various neighborhood settings.

1UG3AG067593-01
Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NIA MAYO CLINIC ROCHESTER CHEVILLE, ANDREA LYNNE (contact); TILBURT, JON C Rochester, MN 2019
NOFO Title: HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)(UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-AT-19-004
Summary:

Prescriptions for narcotic pain relief after surgery result in unintended prolonged opioid use for hundreds of thousands of Americans. Nonpharmacological pain care is effective and recommended by guidelines for perioperative pain while offering a more favorable risk-benefit ratio. However, nonpharmacological pain care is rarely used as first or second-line therapy after surgery. Patient and clinician decision support interventions are effective in encouraging patient-centered and guideline-concordant care, but these strategies have not been tested pragmatically as a bundle in everyday postoperative pain care. The NOHARM trial will first confirm the feasibility of patient-facing and clinician-facing decision support components of an EHR-embedded evidence-based bundle. The investigators will test the bundle in a stepped-wedge cluster randomized trial. They will test a sustainable system strategy that could change the paradigm of perioperative pain management toward nonpharmacological options in a manner that preserves patient function, honors patient values, and maintains availability of opioids as a last resort.

3U01AA021691-08S1
NATIONAL CONSORTIUM ON ALCOHOL AND NEURODEVELOPMENT IN ADOLESCENCE: OHSU New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIAAA Oregon Health & Science University NAGEL, BONNIE J Portland, OR 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
3R34AA025480-02S1
IMPLEMENTING MEDICATION-ASSISTED THERAPY FOR SUBSTANCE USE DISORDERS IN MENTAL HEALTH New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIAAA Rand Corporation WATKINS, KATHERINE E SANTA MONICA, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Substance use disorders (SUDs) can have devastating consequences for people with serious mental illness (SMI). SUDs can increase morbidity and mortality and are associated with higher healthcare and social costs, homelessness, and incarceration. Unfortunately, despite the availability of effective treatments, most individuals with co-occurring SMI and SUD (COD) never receive SUD treatment. We propose to evaluate system, provider, and patient-level facilitators and barriers and develop an implementation strategy and toolkit to promote the use of medication-assisted treatment (MAT) for people with COD. Aims 1–3 seek to assess organizational capacity (at the system and provider level); organizational readiness (at the provider level); and perceived needs, attitudes, and preferences (at the patient level) to identify barriers and facilitators. In Aim 4, we will use findings from Aims 1–3 to guide development of the implementation strategy and toolkit, using stakeholder input and a systematic process for strategy development.

3R01AA025848-03S1
AOD Use Trajectories from Age 10 to 24: Multi-level Predictors, Health and Behavioral Functioning, and Racial/ethnic Disparitie New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIAAA RAND Corporation D'Amico, Elizabeth J. Santa Monica, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

There is a great deal of research aimed at better understanding transitions in alcohol and other drug (AOD) use patterns from early to late adolescence and from late adolescence to emerging adulthood. However, no studies to date have (a) assessments of AOD use from ages 10 to 24 across all developmental periods (middle school, high school, and emerging adulthood); (b) a large sample with substantial racial and ethnic diversity, particularly among Hispanic and Asian youth; (c) in-depth coverage of 10 areas of functioning across three key domains; (d) subjective and objective neighborhood data; or (e) the capacity to examine developmental trajectories for more than one substance. The current proposal is a continuation of previous projects that assessed AOD use across nine waves of data from age 10 to age 19. The proposed study capitalizes on the longitudinal data on protective and risk factors we have collected since age 10 in an ethnically diverse cohort by continuing to annually assess these youth in order to capture important transitions to emerging adulthood (through age 24). By advancing the epidemiology of alcohol use during adolescence and emerging adulthood, our findings can affect prevention and intervention programming for young people and address critical issues of public health policy.

5R01AI132030-02
MINING REAL-TIME SOCIAL MEDIA BIG DATA TO MONITOR HIV: DEVELOPMENT AND ETHICAL ISSUES Translation of Research to Practice for the Treatment of Opioid Addiction NIAID UNIVERSITY OF CALIFORNIA LOS ANGELES YOUNG, SEAN Los Angeles, CA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Social big data analysis of publicly available user data on social media platforms is a promising approach for attaining organic observations of behavior that can monitor and predict real-world public health problems, such as HIV incidence. In preliminary research, our team identified and collected tweets suggesting HIV risk behaviors (e.g., drug use, high-risk sexual behaviors), modeled them alongside CDC statistics on HIV diagnoses, and found a significant positive relationship between HIV-related tweets and county-level HIV cases. We propose to create a single automated platform that collects social media data, identifies and labels tweets that suggest HIV-related behaviors, and predicts regional HIV incidence. We will interview staff and participants at local and regional HIV organizations to understand ethical issues associated with mining people’s data. The software developed from this application will be shared with HIV researchers and health care workers to combat the spread of HIV.


Development of Vaccines for the Treatment of Opioid Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Development of Novel Immunotherapeutics for Opioid Addiction NIAID Boston Children's Hospital Ofer Levy Boston, MA 2020
NOFO Title: Development of Vaccines for the Treatment of Opioid Use Disorder
NOFO Number: BAA-DAIT-75N93019R00009
Summary:

High rates of relapse and overdose deaths pose significant challenges to the treatment of Opioid Use Disorder (OUD). Anti-opioid immunotherapies (i.e., vaccines and monoclonal antibodies) have great potential to reduce long-term opioid use and overdose, with minimal risk of side effects, when used in conjunction with pharmacological treatments and/or behavioral therapies. The ability of an anti-opioid vaccine to induce antibodies that render an opioid less effective, or less rewarding, and protect from accidental overdose could provide an important therapeutic option for patients undergoing treatment for OUD. The goal of this collaborative study is to design, develop, and evaluate vaccines for use in the treatment of opioid use disorder


Adjuvanted Opioid Vaccine for Treating Fentanyl Use Disorder to Reduce Poisoning and Fatal Overdose Novel Therapeutic Options for Opioid Use Disorder and Overdose Development of Novel Immunotherapeutics for Opioid Addiction NIAID University of Montana Jay Evans Missoula, Montana 2020
NOFO Title: Development of Vaccines for the Treatment of Opioid Use Disorder
NOFO Number: BAA-DAIT-75N93019R00009
Summary:

High rates of relapse and overdose deaths pose significant challenges to the treatment of Opioid Use Disorder (OUD). Anti-opioid immunotherapies (i.e., vaccines and monoclonal antibodies) have great potential to reduce long-term opioid use and overdose, with minimal risk of side effects, when used in conjunction with pharmacological treatments and/or behavioral therapies. The ability of an anti-opioid vaccine to induce antibodies that render an opioid less effective, or less rewarding, and protect from accidental overdose could provide an important therapeutic option for patients undergoing treatment for OUD. The goal of this collaborative study is to design, develop, and evaluate vaccines for use in the treatment of opioid use disorder

3U19AR076734-01S1
University of Michigan BACPAC Mechanistic Research Center Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF MICHIGAN AT ANN ARBOR CLAUW, DANIEL J Ann Arbor, MI 2020
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:

There are numerous non-pharmacological interventions for chronic low back pain, yet no treatment is invariably effective for all. Understanding patient characteristics that predict differential responses to these non-pharmacological interventions will allow for tailored treatments to maximize positive patient impact. This supplement supports a training experience for an individual in clinical pain research, including exploring differential response to psychotherapeutic interventions. The aim of the project is to provide an extensive systematic literature review examining baseline phenotypic factors that predict differential responsiveness to the some of the most commonly used psychotherapeutic interventions for chronic low back pain.

1U19AR076725-01
HEALing LB3P: Profiling Biomechanical, Biological and Behavioral phenotypes Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF PITTSBURGH AT PITTSBURGH SOWA, GWENDOLYN A (contact); VO, NAM V Pittsburgh, PA 2019
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19 Clinical Trial Optional)
NOFO Number: RFA-AR-19-026
Summary:

The University of Pittsburgh Low Back Pain: Biological, Biomechanical, and Behavioral Phenotypes (LB3P) Mechanistic Research Center (MRC) will to perform in-depth phenotyping of patients with chronic low back pain (cLBP), using a multimodal approach to characterize patients and provide insight into the phenotypes associated with experience of cLBP to direct targeted and improved treatments. The LB3P MRC will be formed of three Research Cores, three support cores, and one research project. This approach will leverage and integrate distinctive resources at the University of Pittsburgh laboratories to deliver quantified biomechanical, biological, and behavioral characteristics; functional assessments; and patient-reported outcomes, coupled with advanced data analytics using a novel Network Phenotyping Strategy (NPS). By eliminating isolated and disconnected approaches to treatment and focusing on personalized patient-centric approaches, this approach will yield improved outcomes and patient satisfaction.

1U24AR076730-01
Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIV OF NORTH CAROLINA CHAPEL HILL ANSTROM, KEVIN J (contact); IVANOVA, ANASTASIA ; LAVANGE, LISA Chapel Hill, NC 2019
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-AR-19-027
Summary:

The BACPAC Research Program’s Data Integration, Algorithm Development, and Operations Management Center (DAC) will bring cohesion to research performed by the participating Mechanistic Research Centers, Technology Research Sites, and Phase 2 Clinical Trials Centers. DAC Investigators will share their vision and provide scientific leadership and organizational support to the BACPAC Consortium. The research plan consists of supporting design and conduct of clinical trials with precision interventions that focus on identifying the best treatments for individual patients. The DAC will enhance collaboration and research progress with experienced leadership, innovative design and analysis methodologies, comprehensive research operations support, a state-of-the-art data management and integration system, and superior administrative support. This integrated structure will set the stage for technology assessments, solicitation of patient input and utilities, and the evaluation of high-impact interventions through the innovative design and sound execution of clinical trials, leading to effective personalized treatment approaches for patients with chronic lower back pain.

3UH3AR077360-03S1
A sequenced-strategy for improving outcomes in patients with knee osteoarthritis pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIAMS JOHNS HOPKINS UNIVERSITY CAMPBELL, CLAUDIA MICHELLE (contact); CASTILLO, RENAN C; COHEN, STEVEN P Baltimore, MD 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Knee osteoarthritis is one of the leading causes of disability worldwide, particularly among older adults. Despite multiple guidelines for care, most patients do not receive adequate treatment, and about 30% are prescribed long-term opioids. This award will be used to recruit and support an early career faculty member from a group underrepresented in biomedicine. This research, part of the Pain Management Effectiveness Research Network will evaluate conservative and more aggressive treatments for knee osteoarthritis and determine which individual-level factors contribute to treatment outcomes.

1UG3AR076568-01
Proof of concept study to treat negative affect in chronic low back pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF PITTSBURGH AT PITTSBURGH WASAN, AJAY D Pittsburgh, PA 2019
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AR-19-029
Summary:

The chronic low back pain (cLBP) subgroup with comorbid depression or anxiety disorders, known as high negative affect (NA), needs better non-opioid, comprehensive pain treatment options. Data shows that the combination of antidepressants (AD) and fear avoidance physical therapy is more efficacious at improving pain, function, depression, and anxiety in cLBP patients with high NA than each treatment alone or a control condition. Research also finds that an enhanced fear avoidance rehabilitation protocol (EFAR; fear avoidance-based physical therapy, pain education, and motivational messaging) further improves outcomes. To address the unmet needs of cLBP patients with high NA, this study will test in a randomized trial whether the combination of AD and EFAR is more effective than each treatment alone at relieving pain, improving function, combating depression, and preventing opioid misuse. This multimodal combination approach of pharmacotherapy and behavioral therapy is novel to the field and has the potential to shift current treatment paradigms.

3U19AR076737-01S1
UCSF Core Center for Patient-centric Mechanistic Phenotyping in Chronic Low Back Pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO LOTZ, JEFFREY C. San Francisco, CA 2020
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:

Chronic low back pain is difficult to diagnose and treat effectively in part, because of the interplay of biophysical and psychosocial influences that complicate the relationship between impairment, disability, and pain. Psychological factors such as fear of movement and catastrophyzing can lead to compensatory movement patterns that affect movement biomechanics and paraspinal structure and function, driving further impairment, disrupting the balance between passive and active spine stabilizers, and reinforcing the patient?s perceived disability status. This study will support research to determine how psychological factors, spinal pathology, and perception of pain severity and disability status influence compensatory movement strategies, how movement biomechanics, psychological factors, and pain mechanisms relate to paraspinal muscle quality, and their relative changes during treatment. The supplement will provide training opportunities for skills in clinical pain management research.

1UG3AR076573-01
Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS CEDARS-SINAI MEDICAL CENTER SPIEGEL, BRENNAN Los Angeles, CA 2019
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AR-19-029
Summary:

Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for musculoskeletal pain, including chronic low back pain (cLBP). Users of VR wear a pair of goggles with a close-proximity stereoscopic screen that creates a sensation of being transported into lifelike, three-dimensional worlds. By stimulating the visual cortex while engaging other senses, VR modulates the user’s processing of nociceptive stimuli. Functional magnetic resonance imaging (fMRI) of the brain reveals that VR has similar effects on the sensory and insular cortex as opioids, and head-to-head trials show that VR achieves similar or greater analgesia as hydromorphone. Since there are few data regarding long-term efficacy and safety of VR in cLBP, this study will measure patient-reported outcomes, biometric outcomes, and opioid use in nonspecific cLBP patients under various experimental conditions using VR therapy.

1R43AR074369-01
Development of a fixed-dose combination therapy for the treatment of chronic musculoskeletal pain Cross-Cutting Research Small Business Programs NIAMS NEUROCYCLE THERAPEUTICS, INC. TOCZKO, MATTHEW ALEXANDER Sheridan, WY 2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-17-302
Summary:

Non-steroidal anti-inflammatory drugs (NSAIDs) are a first line pharmacologic pain therapy for chronic musculoskeletal pain, and rheumatoid arthritis (RA) and moderate to severe osteoarthritis (OA) specifically. However, insufficient pain relief by NSAID monotherapy has encouraged the use of combination therapy. Combinations of NSAIDs plus weak opioids are widely used although objective evidence for efficacy is limited and they have many adverse events.  A growing body of evidence suggests that ?2/?3 subtype-selective positive allosteric modulators (PAM) of the ?- aminobutyric acid A receptor (GABAAR) may effectively restore central pain regulatory mechanisms thus providing effective relief of chronic pain with reduced prevalence and severity of side-effects.  Based on these promising preliminary studies and considerable supporting literature data, the research team will test the hypothesis that combination dosing of TPA-023B with an NSAID will work synergistically to suppress the acute and chronic pain components of chronic musculoskeletal pain. 

1UG3AR083838-01
Improving Function and Reducing Opioid Use for Patients with Chronic Low Back Pain in Rural Communities Through Improved Access to Physical Therapy Using Telerehabilitation Clinical Research in Pain Management Prevention and Management of Chronic Pain in Rural Populations NIAMS JOHNS HOPKINS UNIVERSITY SKOLASKY, RICHARD L (contact); MCLAUGHLIN, KEVIN Baltimore, MD 2023
NOFO Title: HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3, Clinical Trials Required)
NOFO Number: RFA-NR-23-001
Summary:

Physical therapy is the recommended treatment for patients with low back pain and is a cost-effective method for improving pain and reducing disability. However, only 7-13% of patients receive physical therapy services. Access is particularly limited in rural communities due to lack of provider availability, transportation, and missed work time. These factors have contributed to more low back pain-related disability and opioid use among rural populations. Physical therapy delivered through telemedicine may improve access by reducing patient-reported barriers. This randomized clinical trial will compare an innovative, patient-centered telemedicine version of physical therapy to a currently used psychologically based educational approach for rural patients with chronic low back pain. The research will match individual patients to a treatment approach based on their psychosocial risk of poor outcomes.

1U19AR076737-01
UCSF Core Center for Patient-centric Mechanistic Phenotyping in Chronic Low Back Pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO LOTZ, JEFFREY C San Francisco, CA 2019
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19 Clinical Trial Optional)
NOFO Number: RFA-AR-19-026
Summary:

The UCSF Core Center for Patient-centric Mechanistic Phenotyping in Chronic Low Back Pain (UCSF REACH) is an interdisciplinary consortium of basic and clinical scientists dedicated to understanding and clarifying the biopsychosocial mechanisms of chronic low back pain (cLBP). The goal of REACH is to define cLBP phenotypes and pain mechanisms that can lead to effective, personalized treatments for patients across the population. UCSF REACH has six cores that will support a single research project that is focused on the challenge of developing validated and adoptable tools that enable comprehensive yet routine clinical assessment and treatment of cLBP patients. Overall, the object of REACH is to make optimum use of all available resources to catalyze discovery and translation of novel diagnostics and therapeutics that improve outcomes of cLBP patients.