Funded Projects

Project # Project Title Sort descending Research Focus Area Research Program Administering IC(s) Institution(s) Investigator(s) Location(s) Year Awarded
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 CROFFORD, LE; SLUKA, KATHLEEN A Iowa City, IA 2019
FOA Title: HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)(UG3/UH3 Clinical Trial Optional)
FOA 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.

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
FOA Title: HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)(UG3/UH3 Clinical Trial Optional)
FOA 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.

1U24AT010961-01
HEAL Collaboratory Resource Coordinating Center (PRISM) Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NCCIH DUKE UNIVERSITY HERNANDEZ, ADRIAN; CURTIS, LESLEY H; WEINFURT, KEVIN P Durham, NC 2019
FOA Title: HEAL Initiative: Limited Competition: Resource Coordinating Center for Pragmatic and Implementation Studies for the Management of Pain (PRISM) to Reduce Opioid Prescribing (U24 Clinical Trial Not Allowed)
FOA Number: RFA-AT-19-011
Summary:

Improved pain management and reduction of opioid use could greatly benefit from improved pragmatic clinical trials (PCTs). The PRISM Resource Coordinating Center (CC), as part of the NIH Health Care Systems Research Collaboratory, will support up to nine more embedded PCTs that address pain management and the opioid crisis. Since 2012, the CC has nurtured 15 Demonstration Projects by providing leadership, resources, tools, training, and coordination of diverse elements. The CC will work collaboratively with each PRISM Demonstration Project team supported through the HEAL Initiative, including their partnering health care systems, to develop, test, and implement the projects while providing technical, design, and coordination support. The CC will also develop and refine technical and policy guidelines and best practices for the effective conduct of pain-related research studies in partnership with health care systems and disseminate best strategies for successful embedded PCTs.

1UG3AT010669-01
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; TILBURT, JON C Rochester, MN 2019
FOA Title: HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)(UG3/UH3 Clinical Trial Optional)
FOA 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.

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; DEBAR, LYNN L Oakland, CA 2019
FOA Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
FOA 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.