Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1U24NS113784-01	University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	UNIVERSITY OF ROCHESTER	MARKMAN, JOHN DOUGLAS (contact); GEWANDTER, JENNIFER	Rochester, NY	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-025 Summary: The NIH’s HEAL Initiative aims to support collaboration between clinical research experts in academia and industry to accelerate the development of highly efficacious, nonaddictive analgesics for well-defined chronic pain syndromes. The University of Rochester (UR), and its leadership for the UR Hub and Spokes within Early Phase Pain Investigation Clinical Network (EPPIC-Net), will recruit subjects with a broad range of pain conditions, with a focus on leveraging clinical trial infrastructure to support patient recruitment and retention, timely and accurate data entry, and regulatory documentation, as well as recruit additional Spoke sites through a national network of analgesic researchers.
1U24NS113800-01	University of Florida Early Phase Pain Investigation Clinical Center	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	UNIVERSITY OF FLORIDA	PRZKORA, RENE (contact); TIGHE, PATRICK J	Gainesville, FL	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-025 Summary: A major barrier to developing new pain treatments has been the absence of infrastructure to facilitate well-designed and carefully conducted clinical trials to test the efficacy of promising treatments. The UF Health Specialized Clinical Center Network will include UF Health as “hub” and statewide partners serving as spokes as part of the EPPIC Network. The University of Florida (UF) has the capability to reach more than 50% of the population of Florida, the third most populous state of the United States, and the capacity to successfully enroll patients with varying pain conditions into clinical trial protocols through its hub and spoke infrastructure as part of EPPIC-Net.
1U24NS113844-01	EPPIC-NET DCC	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	PETKOVA, EVA (contact); TROXEL, ANDREA B	New York, NY	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-024 Summary: The Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will be the data and biospecimen manager for pain research within the HEAL Partnership. As such, it will host, manage, standardize, curate, and provide a sharing platform for data and biospecimens for HEAL initiatives, such as the Acute to Chronic Pain Signatures initiative and the BACPAC, in addition to EPPIC-Net studies. The DCC will develop and maintain a databank for depositing data, will link these data with a repository for biological samples, and will create a platform for teams to work together to analyze and interpret data. Further, the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies and will deploy advanced systems and processes for data collection, management, quality assurance, and reporting. The DCC will create, sustain, and continually advance a robust organization for the rapid design, implementation, and performance of high-quality rigorous Phase II clinical trials to test promising therapeutics for pain.
1U24NS113846-01	Medical University of South Carolina Specialized Clinical Center of EPPIC-Net	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	MEDICAL UNIVERSITY OF SOUTH CAROLINA	BORCKARDT, JEFFREY J (contact); BRADY, KATHLEEN T	Charleston, SC	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-025 Summary: The Medical University of South Carolina (MUSC) Specialized Clinical Center (Hub) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will provide a robust and readily accessible infrastructure for rapid implementation and performance of high-quality comprehensive studies of novel treatments for patients with a wide variety of pain conditions. The MUSC-Hub will harness multidisciplinary clinical, research, statistical, and data management expertise to provide the scientific leadership and infrastructure required to design and conduct multisite Phase II clinical trials, biomarker validation studies, and deep phenotyping of patient populations as part of the EPPIC-Net with the overall goal of accelerating the development of new therapies for patients with acute and/or chronic pain.
1U24NS113847-01	Early Phase Pain Investigation Clinical Network: Greater New York Clinical Center	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	DOAN, LISA (contact); LIPTON, RICHARD B	New York, NY	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-025 Summary: The Greater New York Clinical Center (GNYCC) aims to engage experts in pain research and pain practice to build the infrastructure required to support the objectives of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The GNYCC will provide expertise and resources to perform phase 2 clinical trials to test the efficacy of novel pain treatments, as well as phenotyping and biomarker studies that will enable customized treatments. The consortium comprises four major academic centers in New York City, one of the most diverse cities in the United States and the nation’s largest metropolitan area. We will 1) build infrastructure to rapidly access clinical trial resources and a network of investigators and clinical leaders, 2) develop a plan for swift evaluation and launch of proposed studies, and 3) optimize patient retention and monitor sites to ensure protocol adherence, data quality, and efficiency.
1U24NS113849-01	The Icahn School of Medicine at Mount Sinai (ISMMS) EPPIC-Net Specialized Clinical Center	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ROBINSON-PAPP, JESSICA	New York, NY	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-025 Summary: The Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network.
1U24NS113850-01	Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	MASSACHUSETTS GENERAL HOSPITAL	FAVA, MAURIZIO (contact); EDWARDS, ROBERT R; RATHMELL, JAMES P	Boston, MA	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-023 Summary: The objective of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) and EPPIC- Net initiatives is to rapidly and efficiently translate advances in the neurobiology of pain into treatments for people with chronic and acute pain, conditions associated with a significant burden to both patients and society. The Clinical Coordinating Center (CCC) for EPPIC-Net will promote and facilitate, from initial conception through final analysis, clinical trials in adult and pediatric populations with acute or chronic pain by providing efficient methodological, organizational, and logistical support. The EPPIC-Net-CCC will adopt and establish processes aimed at dramatically increasing the efficiency of multicenter clinical trials, improving the overall quality of clinical trials, promoting patient recruitment and retention as well as increasing the number of clinical investigators and research staff well trained and passionate about leading and conducting multicenter clinical trials.
1U24NS114416-01	Duke Pain Early-phase Research Clinical Center (PERC)	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	DUKE UNIVERSITY	LIMKAKENG, ALEXANDER TAN (contact); PORTER, LAURA S	Durham, NC	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed) NOFO Number: RFA-NS-19-025 Summary: Managing persistent pain has long been a difficult challenge, one that is heightened by the recent opioid crisis. Although many potential solutions may exist, demonstrating their efficacy in a multicenter trial is a considerable obstacle. There is broad consensus that a nationwide clinical research network is necessary to promote innovation. A hub-spoke complex of academic medical centers with considerable experience in pain management clinical trials and biomarker validation will leverage existing resources to make clinical trial execution efficient and rapid. Together, spokes will provide maximum flexibility, ready to accommodate studies in any well-characterized pain condition.
1U24NS115678-01	EPPIC-Net Hub at University of Washington	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	University of Washington	BACKONJA, MIROSLAV MISHA (contact); CURATOLO, MICHELE ; STACEY, BRETT	Seattle, WA	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed) NOFO Number: RFA-NS-19-036 Summary: The Helping to End Addiction Long-term? (HEAL) Initiative’s Early Phase Pain Investigation Clinical Network (EPPIC-Net) is a unique opportunity to impact the management of pain, through expeditious discovery and validation of biomarkers and analgesic therapies, and in-depth phenotyping. The University of Washington’s (UW) Division of Pain Medicine (UW Pain; “hub”) includes four core clinical sites. Committed spokes include specialty care clinics, primary care clinics, external academic medical centers, and health systems. To achieve the goals of the HEAL Initiative’s EPPIC-Net, the study group will (1) establish UW EPPIC-Net hub and spokes infrastructure, provide scientific leadership and administrative oversight, and apply expertise in design and conduct of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies; (2) develop policies and procedures for rapid design, initiation, recruitment, conduct, and closure of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies for specific pain conditions at UW Pain EPPIC-Net hub and spokes; and (3) establish mechanisms for communication, education and training, and performance assessment of the UW-EPPIC-Net hub and spokes, to assure efficient and timely utilization of resources to most effectively recruit research participants into EPPIC-Net.
1U24NS115679-01	MACC/EPICC-Net as a Hub for the HEAL Initiative EPICC-Net	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	MEDICAL COLLEGE OF WISCONSIN	HERNANDEZ-MEIER, JENNIFER LYNN (contact); AUFDERHEIDE, TOM PAUL	Madison, WI	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed) NOFO Number: RFA-NS-19-036
1U24NS115689-01	Specialized Clinical Center at MGH for the Early Phase Pain Investigation Clinical Network	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	MASSACHUSETTS GENERAL HOSPITAL	MAO, JIANREN	Boston, MA	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed) NOFO Number: NS115689-01 Summary: The MGH EPPIC-Net hub will utilize two well-established collaborative entities in both patient care and clinical research at the Massachusetts General Hospital (MGH): 1) MGH Division of Pain Medicine and 2) MGH Center for Translational Pain Research. This hub-spoke network at MGH will include four core spokes consisting of both academic centers and community health care organizations, as well as over a dozen spokes that can be recruited as needed based on special requirements of phase II trials and research studies. The responsibilities of this hub-spoke network at MGH include a) coordinating phase II trials/clinical biomarker validation studies; b) recruiting well-phenotyped subjects in a timely manner; c) collecting clinical data and targeted outcome data tailored to meet the needs of each clinical trial/study; and d) maintaining communications within and outside the hub, including the NIH EPPIC-Net.
1U24NS115691-01	UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	UNIVERSITY OF PENNSYLVANIA	FARRAR, JOHN T (contact); ASHBURN, MICHAEL ALAN	Philadelphia, PA	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed) NOFO Number: RFA-NS-19-036 Summary: EPPIC-Net will provide a robust and readily accessible infrastructure for the rapid implementation and performance of high-quality comprehensive studies of patients with well-defined pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. Using the Hospital of the University of Pennsylvania as a hub and five additional centers that are part of the UPenn Health System and the Children’s Hospital of Philadelphia (CHOP) as spokes, studies will be conducted as designed by the expertise of the EPPIC Network, which intends to bring intense focus to relatively small numbers of patients with clinically well-defined pain conditions and high unmet therapeutic needs. The UPenn Specialized Clinical Center (SCC) will test novel, efficient study designs including adaptive and platform designs, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in Phase 2 trials of interventions from academic and industry partners.
1U24NS115708-01	University of Pittsburgh Hub and Spoke Pain Clinical Trial Network	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	WASAN, AJAY D (contact); ALTER, BENEDICT J	Pittsburgh, PA	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed) NOFO Number: RFA-NS-19-036 Summary: For many years in the field of pain medicine it has been noted that many promising treatments emerging from animal studies fail to demonstrate efficacy in human trials. There are many reasons for these phenomena, and one of the key steps to improve this situation and establish more effective nonopioid treatments for pain is more rigorous conduct of multisite pain clinical trials from an experienced multidisciplinary team of investigators. The University of Pittsburgh Hub and Spoke Clinical Trials Network will establish an organizational structure to capitalize on institutional expertise at our Spokes to lead specific phase 2 clinical trials through EPPIC-Net.
1U24NS115714-01	California Clinical and Translational Pain Research Consortium	Clinical Research in Pain Management	Early Phase Pain Investigation Clinical Network (EPPIC-Net)	NINDS	UNIVERSITY OF CALIFORNIA, SAN DIEGO	WALLACE, MARK S	San Diego, CA	2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed) NOFO Number: RFA-NS-19-036 Summary: The California Clinical and Translational Pain Research Consortium (CCTPRC) consists of four University of California academic medical centers with considerable experience in pain management clinical trials, phenotyping, and biomarker validation. The network will leverage solid existing Clinical and Translational Science Award (CTSA) resources to make clinical trial execution efficient and rapid. The hub will be located at the University of California, San Diego, with spokes located on the other three campuses to provide maximum flexibility, ready to accommodate studies in a variety of pain conditions and provide successful recruitment and high-quality data collection.
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.
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.
1UG3AR076387-01	Fibromyalgia TENS in Physical Therapy Study (TIPS): An embedded pragmatic clinical trial	Clinical Research in Pain Management	Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)	NIAMS	UNIVERSITY OF IOWA	SLUKA, KATHLEEN A (contact); CROFFORD, LESLIE J	Iowa City, IA	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: Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness, and stiffness associated with fatigue and sleep disturbance. The investigators have recently completed a trial that demonstrated efficacy of active transcutaneous electrical nerve stimulation (TENS) compared with placebo TENS or no treatment in women with FM. While physical therapists are trained in using TENS, it is underused in clinical practice. This application proposes a pragmatic clinical trial of TENS for patients with FM to determine if the addition of TENS to physical therapy (PT) reduces pain, increases PT adherence, and helps achieve functional goals with less drug use. This study will address the critical need for strategies to implement effective nonpharmacologic treatments for FM. Successful completion of this trial will provide generalizable effectiveness data for referring providers, physical therapists, and insurers and will inform future pragmatic trials of nonpharmacologic treatments conducted in PT practices.
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.
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 userâ€™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.
1UG3AR077360-01	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	COHEN, STEVEN P (contact); CAMPBELL, CLAUDIA MICHELLE; CASTILLO, RENAN C	Baltimore, MD	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: The goal of this proposal is to conduct a randomized controlled trial to evaluate the comparative effectiveness of conservative behavioral and nonopioid pharmacological treatments (Phase I) and, among nonresponders, the benefits of nonsurgical procedural interventions (Phase II). Aim 1 will evaluate the effectiveness of individual and combined online cognitive behavioral therapy (painTRAINER) and pharmacologic treatment (duloxetine) in improving pain and function for knee osteoarthritis (KOA) patients compared with standard of care. Aim 2 will determine if genicular nerve radiofrequency ablation or intra-articular injection of hyaluronic acid and steroid is more effective in improving outcomes than local anesthetic nerve block or standard of care and help establish the role of these interventional treatments in the overall management of pain in KOA patients. Aim 3 will test whether clinical and psychosocial phenotypes predict short- and long-term treatment response.
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.
1UG3AT010621-01	Group-based mindfulness for patients with chronic low back pain in the primary care setting	Clinical Research in Pain Management	Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)	NCCIH	BOSTON MEDICAL CENTER	MORONE, NATALIA E	Boston, MA	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: The opioid crisis has underscored the urgency of alleviating patients’ chronic low back pain (cLBP) with effective therapies, including evidence-based nonpharmacologic approaches. Mindfulness-based stress reduction (MBSR) is now recommended by the American College of Physicians for initial treatment of cLBP. A pragmatic clinical trial (PCT) will inform health care decision makers about whether this program can be implemented in a real-life clinical setting and measure its impact on outcomes. The OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness) program will integrate and test an evidence-based mindfulness clinical pain program for patients with cLBP in the primary care provider (PCP) setting. It will be conducted with three health care system sites. Four hundred and fifty persons ? 18 years of age with cLBP will be randomized to OPTIMUM + PCP Usual Care or PCP Usual Care.
1UG3AT010739-01	Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults	Clinical Research in Pain Management	Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)	NCCIH	KAISER FOUNDATION RESEARCH INSTITUTE	SHERMAN, KAREN J (contact); DEBAR, LYNN L	Oakland, CA	2019
NOFO Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required) NOFO Number: RFA-AT-19-005 Summary: Acupuncture has been found to be effective in treating chronic lower back pain (cLBP) in adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently from typical trial participants. To fill this gap, the study team will conduct a three-arm trial of 828 adults ?65 years of age with cLBP to evaluate acupuncture versus usual care. They will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP.
1UG3AT011265-01	Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain	Clinical Research in Pain Management	Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)	NCCIH	UNIVERSITY OF ILLINOIS AT CHICAGO	DOORENBOS, ARDITH Z (contact); EZENWA, MIRIAM OMELEBELE; MOLOKIE, ROBERT E; SCHLAEGER, JUDITH MICHELLE; SHAH, NIRMISH R	Chicago, IL	2020
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: In the US, approximately 100,000 people, mainly of African and Hispanic background have Sickle Cell Disease (SCD). Pain is a constant companion and chronic disabling symptom for those with SCD. It is increasingly clear that adults with chronic SCD pain also experience periods of acute worsening of their pain. The evaluation of nonpharmacological therapies that reduce chronic pain and the need for opioid medication among individuals with SCD is critically needed to address lack of adequate pain control to prevent periods of acute deterioration and high opioid use with negative sequelae. The investigators will conduct a hybrid type 1 effectiveness-implementation trial to assess the effectiveness of acupuncture and guided relaxation in patients with SCD while observing and gathering information on implementation in three health systems. The study will utilize a 3-arm, 3-site pragmatic randomized controlled SMART trial design that evaluates adaptive interventions, in which selection of interventions responds to patients? characteristics and evolving clinical status. The investigators will use the Consolidated Framework for Implementation Research to plan, execute, and evaluate implementation processes.
1UG3CA261067-01	Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain	Clinical Research in Pain Management	Pain Management Effectiveness Research Network (ERN)	NINDS	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	WANG, JING (contact); DOAN, LISA	New York, NY	2020
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-20-028 Summary: Approximately 20% of patients who undergo surgery develop chronic pain, or Chronic Postsurgical Pain (CPSP). CPSP is highly associated with impaired functional recovery and persistent opioid use and dependence, and current standard postoperative multimodal analgesia is only moderately effective for its prevention. This study aims to determine whether the use of ketamine during and/or after surgery prevents Post-Mastectomy Pain Syndrome (PMPS), one of the most common CPSP conditions. Ketamine is a low-risk treatment option that is easy to implement in a wide range of clinical settings. If successful, this treatment could improve postoperative pain management in individuals undergoing mastectomy and help combat the opioid epidemic.