August 25, 2021
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
The purpose of this request for administrative supplements to current NIH-funded studies is to encourage clinical and translational research that will increase our understanding of the prevalence, psychological variables, and response to therapy in those individuals with multiple chronic overlapping pain conditions (COPCs). Recent clinical findings suggest that substantial overlap may exist between chronic pain conditions. Individuals diagnosed with one pain disorder often exhibit characteristics of additional chronic painful conditions or transition to other diagnostic categories. A better understanding is needed of the characteristics of overlapping pain conditions, the progression of these conditions, and therapeutic approaches best suited for treating individuals with COPCs.
Research efforts in chronic pain conditions have focused on single disorders or types of pain such as neuropathic and inflammatory pain. These research efforts have generated a substantial body of information advancing our understanding of the underlying mechanisms of pain onset and development, the transition from acute to chronic pain, and therapeutic targets for treating acute and chronic pain. Over the past twenty years reports have documented the presence of more than one chronic pain condition in subjects with pain. Studies have identified overlap between a number of chronic pain conditions, including lower back pain, fibromyalgia (FM), vulvodynia, endometriosis, functional gastrointestinal disorders such as irritable bowel syndrome (IBS), temporomandibular joint disorder (TMD), migraine, tension headache, low back pain, and urologic chronic pelvic pain syndromes (UCPPS). These results suggest that chronic pain conditions may not be localized conditions but may share symptoms and mechanisms that involve a general central nervous system dysfunction as well as disorder-specific symptoms. More recent evidence is supportive of the idea that chronic pain conditions are complex disorders consistent with a biopsychosocial model of pain and exhibit substantial overlap. Therefore, this is an opportune time to support additional studies that focus on subjects with COPCs who are enrolled in ongoing studies.
A well-established predictor of onset of COPCs is the presence of a chronic pain condition that is characterized by a state of pain amplification. Several studies found that a large percentage of individuals with diagnosed COPCs demonstrate a state of pain amplification and enhanced pain sensitivity. Whether pain amplification represents a risk determinant versus a consequence of COPCs remains to be determined.
Despite our ability to assess multiple facets relevant to COPCs, treatment of COPCs more generally remains challenging. Current interventions retain a focus on sensory aspects of pain despite the knowledge that chronic pain is heavily influenced by biopsychosocial factors. Evidence-based approaches suggest that combinations of traditional and centrally acting medication produce modest benefits for many COPCs and that combining medications with nonpharmacological interventions can produce greater benefits in pain relief and functional status for many of those with COPCs. For example, psychological interventions show significant benefits in individuals with FM, chronic low back pain, and headache. However, clinical pain reductions with these interventions may help only a subset, and overall benefits may be modest at best. Additional nonmedical interventions, such as exercise, also can benefit individuals with COPCs. Despite some positive evidence for combination therapy for COPCs, additional research is needed.
A workshop sponsored by the NIH Pain Consortium was held in 2012 titled "A Workshop on Chronic Overlapping Pain Conditions". It brought together researchers with expertise in various pain conditions and other relevant expertise to discuss these conditions and to develop a forward-thinking research agenda. The workshop focused on the current understanding of chronic overlapping pain conditions, their etiology, risk factors, mechanisms of disease, outcome measures, and diagnosis. An important outcome of that workshop was the development of a Chronic Overlapping Pain Screener, a research tool to assess shared symptoms and characteristics across COPCs. The recommendations derived from this workshop have, in part, informed the development of this request for administrative supplements.
Substantial NIHfunding, particularly within the Helping to End Addiction Long-term (HEAL) Initiative, has been allocated to establish and follow different cohorts of patients with chronic pain. The administrative supplement mechanism will allow NIH to leverage existing studies to examine and follow subsets of enrolled participants with COPCs. The additional funding will cover cost increases that are associated with achieving certain new research objectives, such as additional phenotyping and analyses, as long as the research objectives are within the original scope of the peer reviewed and approved project.
Some of the overlapping pain conditions that could be studied include two or more of: migraine, tension headache, temporomandibular joint disorder, generalized pain conditions, , endometriosis, urologic chronic pelvic pain, vulvodynia, fibromyalgia, chronic low back pain, chronic fatigue syndrome, and functional gastrointestinal disorders such as irritable bowel syndrome. Studies that would be possible to complete with administrative supplements include those providing a better understanding of the epidemiology of chronic overlapping pain conditions, risk factors for COPCs and the response of COPCs to therapeutic interventions. This will be accomplished by enhanced phenotyping of participants already enrolled in HEAL trials and other clinical studies, and additional analyses of the final study datasets.
Specific areas of research that will be considered high priority for this administrative supplement request are:
Note: Applications that propose an additional clinical trial or any other study designed to test and administer an additional intervention are not appropriate for this administrative supplement.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
Please direct all inquiries to:
Linda L. Porter, PhD
National Institute of Neurological Disorders and Stroke (NINDS)