Funded Projects

Project # Project Title Sort descending Research Focus Area Research Program Administering IC(s) Institution(s) Investigator(s) Location(s) Year Awarded
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 LAVANGE, LISA Chapel Hill, NC 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center (U24 Clinical Trial Not Allowed)
FOA 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.

1UH2AR076731-01
Development, Evaluation and Translation of Robotic Apparel for Alleviating Low Back Pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS HARVARD UNIVERSITY WALSH, CONOR Cambridge, MA 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
FOA Number: RFA-AR-19-028
Summary:

A primary factor contributing to acute or recurrent back injury is overexertion via excessive peak and cumulative forces on the back and the primary factors involved in the progression of acute low back injury to chronic low back pain (cLBP) include maladaptive motor control strategies, muscle hyperactivity, reduced movement variability, and the development of fear cognitions. This project will focus on the development of robotic apparel with integrated biofeedback components that can reduce exertion; encourage safe, varied movement strategies; and promote recovery. Robotic apparel will be capable of providing supportive forces to the back and hip joints through adaptive control algorithms that respond to dynamic movements and becoming fully transparent when assistance is no longer needed. This technology can be used to prevent cLBP caused by overexertion and provide a new tool to physical therapists and the clinical community to enhance rehabilitation programs.

3UH3AR076568-02S1
Examining the effect of intersectional stigma on the treatment of 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 2020
FOA 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
FOA Number: NOT-OD-20-101
Summary:

Patients with chronic low back pain, often have depressive and anxiety symptoms and use opioids all of which are associated with stigma. In turn stigma leads to decreased treatment seeking and adherence, increased depression and pain, and poor treatment outcomes. Intersection of these health-related stigmas may have synergistic effects. This study aims to enhance the findings of a clinical trial to test antidepressant medication and Enhanced Fear Avoidance Rehabilitation in patients with chronic low back pain and high levels of depression and anxiety. The effects of these intersecting types of stigma on the efficacy of the interventions will be evaluated to better understand the needs of the patient population and to inform development of a stigma reducing intervention that can be implemented care providers.

1UH2AR076736-01
Focused Ultrasound Neuromodulation of Dorsal Root Ganglion for Noninvasive Mitigation of Low Back Pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF UTAH RIEKE, VIOLA Salt Lake City, UT 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
FOA Number: RFA-AR-19-028
Summary:

This project’s goal is to develop a completely noninvasive, precise, and durable treatment option for low back pain (LBP). Focused ultrasound (FUS) is a lower-risk, completely noninvasive modality that enables the delivery of spatially confined acoustic energy to a small tissue region (dorsal root ganglion [DRG]) under magnetic resonance (MR) imaging guidance to treat axial low back pain by neuromodulation. The central goal of this study is to demonstrate neuromodulation of the DRG with FUS to decrease nerve conduction; this treatment can be used to attenuate pain sensation. This exploratory study will demonstrate FUS neuromodulation of the DRG in pigs as assessed by somatosensory evoked potential and perform unique behavioral assessments indicative of supraspinal pain sensation, with the ultimate goal of translating this technology to patients with LBP. FUS could potentially replace current invasive or systemically detrimental treatment modalities.

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 Pittsburgh, PA 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19 Clinical Trial Optional)
FOA 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.

3U19AR076725-01S1
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 Pittsburgh, PA 2020
FOA 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)
FOA Number: NOT-NS-20-044
Summary:

Multiple factors, including inflammation contribute to chronic low back pain. Inflammation is mediated by numerous genes. The study aims to determine how variations in the genes encoding key inflammatory mediators impact the response of patients with chronic low back pain to physical therapy treatment. Gene variations that are known to be linked to inflammation and pain will be tested against their possible association on physical therapy treatment outcomes, to inform clinical decisions on optimal care. This study will support training in clinical research on pain within the context of the HEAL BACPAC Mechanistic Research Center. It will provide resources for a research project relevant to the parent grant and the career development of an individual in the field of pain research. The ability to identify a set of genetic variations and classify patients according to treatment response might enable use of DNA testing as a screening tool for targeted treatments for patients with CLBP.

1UH2AR076741-01
Imaging Epigenetic Dysregulation in Patients with Low Back Pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS MASSACHUSETTS GENERAL HOSPITAL WEY, HSIAO-YING Boston, MA 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
FOA Number: RFA-AR-19-028
Summary:

Inhibitors of the epigenetic enzymes histone deacetylases (HDACs) produce analgesic responses and are therefore therapeutic targets for pain. The research team recently resolved a PET imaging agent, [11C]Martinostat, that selectively binds to a subset of HDAC enzymes. A series of initial proof-of-concept clinical validation studies will be conducted to evaluate whether [11C]Martinostat PET is a sensitive biomarker to detect the typical (axial) chronic low back pain (cLBP). The research team will validate [11C]Martinostat PET’s ability to differentiate subtypes of pain by comparing axial cLBP and other cLBP patients with radiculopathy and longitudinally study subacute LBP patients (sLBP) to investigate whether there is a unique imaging signature that differentiates patients who develop cLBP and those who recover from low back pain. Using [11C]Martinostat to understand HDAC expression changes in chronic pain patients will validate an epigenetic drug target, refine patient selection based on HDAC expression, and facilitate proof of mechanism in developing novel analgesics.

1UH2AR076719-01
Novel imaging of endplate biomarkers in chronic low back pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO FIELDS, AARON J San Francisco, CA 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
FOA 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.

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
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required)
FOA 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.

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
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required)
FOA 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.

1UH2AR076724-01
Technology Research Site for Advanced, Faster Quantitative Imaging for BACPAC Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO MAJUMDAR, SHARMILA San Francisco, CA 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
FOA Number: RFA-AR-19-028
Summary:

Despite the significance of spine disorders, there are few reliable methods to determine appropriate patient care and evaluate intervention effectiveness. The research and tool development take the critical next step in the clinical translation of faster, quantitative magnetic resonance imaging (MR) of patients with lower back pain. The multidisciplinary Technology Research Site (Tech Site) of BACPAC will develop Phase IV (i.e., technology optimization) technologies and/or methods (TTMs) to leverage two key technical advancements: development of machine learning-based, faster MR acquisition methods and machine learning for image segmentation and extraction of objective disease related features from images. The team will develop, validate, and deploy end-to-end deep learning-based technologies (TTMs) for accelerated image reconstruction, tissue segmentation, and detection of spinal degeneration to facilitate automated, robust assessment of structure-function relationships between spine characteristics, neurocognitive pain response, and patient-reported outcomes.

1UH2AR076729-01
The Spine Phenome Project: Enabling Technology for Personalized Medicine Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS OHIO STATE UNIVERSITY MARRAS, WILLIAM S Columbus, OH 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
FOA Number: RFA-AR-19-028
Summary:

Current diagnostics and treatments of chronic low back pain (cLBP) rely primarily on subjective metrics and do not target all the multidimensional biopsychosocial mechanisms. This multidisciplinary effort will develop and validate a digital health platform and provide meaningful data-driven metrics that enable an integrated approach to clinical evaluation and treatment of cLBP. This platform will facilitate the use of quantitative spinal motion metrics (function), patient-reported outcomes, and patient preference information to enable deep patient phenotyping and inform clinical decision making on personalized treatments in order to improve outcomes. This effort will involve software and hardware development to enable data collection, analysis, and visualization in clinical settings. The outcome of this project will be a digital health platform with data to support regulatory submission for clinical use. At the end of this effort, the researchers will have a validated tool for integration in clinical research studies supported by the BACPAC Consortium.

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
FOA 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)
FOA 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.

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
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19 Clinical Trial Optional)
FOA 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.

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
FOA 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)
FOA 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.

1U19AR076734-01
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 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19 Clinical Trial Optional)
FOA Number: RFA-AR-19-026
Summary:

The University of Michigan (UM) will lead a Mechanistic Research Center (MRC) as part of the broader BACPAC initiative that will take patients with chronic low back pain (cLBP) and use a patient-centric, SMART design study to follow these individuals longitudinally as they try several different evidence-based therapies while mechanistic studies are overlaid to draw crucial inferences about what treatments will work in what patient endotypes. Interventional Response Phenotyping describes the need in any precision medicine initiative to phenotype participants based on what therapies they do and do not respond to so that one can later link mechanistically distinct disease endophenotypes with those who preferentially respond to therapies targeting those mechanisms.

1UH2AR076723-01
Wearable nanocomposite sensor system for diagnosing mechanical sources of low back pain and guiding rehabilitation Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS BRIGHAM YOUNG UNIVERSITY BOWDEN, ANTON E Provo, UT 2019
FOA Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
FOA Number: RFA-AR-19-028
Summary:

Chronic low back pain (cLBP) is recurrent and often nonresponsive to conservative treatments. Biomechanists, physical therapists, and surgeons each utilize a variety of tools and techniques to assess and interpret qualitative movement changes to understand potential mechanical and neurological sources of low back pain and as critical elements in their treatment paradigm. However, objectively characterizing and communicating this information is currently impossible, since clinically feasible (i.e., cost-effective, objective, and accurate) tools and quantitative benchmarks do not exist. This research addresses the challenge to improve cLBP outcomes through the use of unique, inexpensive, screen-printable, elastomer-based, nanocomposite, piezoresponsive sensors, which will be integrated into a SPInal Nanosensor Environment (SPINE) sense system to measure lumbar kinematics and provide an objective, quantitative platform for diagnosis, monitoring, and follow-up assessment of cLBP.