Related Announcements

PA-20-272- Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

The National Center for Complementary and Integrative Health (NCCIH) is inviting applications to expand existing awards, including those focused or not currently focused on pain related research, to develop preliminary data in the following specified areas of pain research. Active awards with project end dates in FY 2023 or later are eligible. The award may not be in a terminal no-cost extension or going into a no-cost extension in FY 2022.

As administrative supplements, the work proposed needs to be within the scope of the research or training that is already supported. Active awards with all activity codes are eligible to apply for this call of Administrative Supplements. Research and training grants will also qualify if the current research is on a pain related topic or if the proposed pain supplement is related to the parent award at the intervention, mechanism, and/or outcome levels. Awardees are encouraged to seek competing support to continue promising leads from the research supported through the supplement. Additional information on areas of interest and funding opportunity announcements can be found here: Funding Opportunities | NCCIH (nih.gov).

For the administrative supplement, only the following research areas will be considered:

1) Basic/Mechanistic, Translational, or Clinical Research on Pain Related to Sickle Cell Disease. Sickle cell disease (SCD) predominantly affects individuals of African descent and those who self-identify as Black. The most common complication of SCD is pain, including severe acute pain episodes and chronic persistent pain, which can be devastating and often requires opioid treatment. Our understanding of the biological cause(s) of pain in patients with sickle cell disease is very inadequate as the extant literature directly addressing the biological mechanisms underlying major clinical features of this painful condition is extremely limited. Furthermore, significant gaps remain in translation of research from bench to beside. Exploratory studies to address these gaps and advance our knowledge on fundamental processes in SCD pain and potential treatments with a variety of therapies including complementary and integrative health approaches are strongly encouraged. For basic research, studies investigating pain processing in clinically relevant organ systems in animal models or human subjects are particularly encouraged.

2) Basic and Mechanistic Understanding of Myofascial Pain. Pain associated with myofascial tissues is among the most common types of chronic pain. Contrary to the conventional wisdom, evidence is emerging that fascia tissues are heavily innervated, but little research is underway to ascertain the interactions between fascia and other tissues involved in pain sensation. Understanding the mechanisms underlying the neuronal innervation of fascia as well as muscles may help uncover novel therapeutic targets for pain management. Exploratory studies to develop preclinical models to study myofascial pain, gain novel understanding of pain pathophysiology involving myofascial tissues, and develop novel therapeutic targets and non-opioid or non-pharmacological therapies for myofascial pain are particularly encouraged.

3) Fundamental Science of Biophysical Force-Based Interventions to Prevent or Manage Chronic Pain. Biophysical force-based interventions, such as massage, acupuncture, chiropractic manipulations, osteopathic treatments, represent non-pharmacological pain management paradigms commonly used by the general public with little scientific insights and evidence. The 2021 Nobel Prize for Physiology and Medicine was awarded, in part, for the discovery of the first mechanoreceptor, the protein in our body to detect the external biophysical force or pressure. Exploratory studies that will build on the exciting and transformative discovery to study the fundamental science of how biophysical force-based interventions may regulate pain related processes or targets in preclinical systems or clinical populations are particularly encouraged.

4) Identifying Novel Therapeutic Targets of Pain for Non-Addictive Natural Products. Natural products, including metabolites products by plants, animals, and microbes, have historically been the sources of many modern medicines. One of the 2021 Nobel Prize for Physiology and Medicine recipients was awarded for the identification of a novel pain receptor in response to the natural product, chili pepper, and is a great example of the importance of searching for novel pain therapeutic targets in response to non-addictive natural products. The following exploratory studies or efforts are strongly encouraged:

a) early phase preclinical exploratory natural product discovery for pain including analgesic, nociceptive, and proprioceptive targets

b) screening of natural product libraries against known or novel targets relevant to pain

c) collection or resupply (e.g., fermentation, cultivation, harvest, extraction, purification, synthesis) of known analgesic natural products for further evaluation

d) mining of existing literature, pharmacopeias, and ancient texts for candidate analgesic natural products worthy of further consideration using modern research methodologies

5) The Science of Music Therapies to Enhance Pain Management. Music and music therapies have often been used by the public and health care centers or hospitals to help relieve pain and soothe the patients. However, little is known about how and why music-based interventions could help with pain relief and how we could optimize their pain-relief effects. Innovative exploratory studies to understand the fundamental science underlying music's power for pain relief or support clinical research to optimize and enhance music's therapeutic effects for pain are particularly encouraged.

6) Multi-Component Pain Management Intervention Development. Research has demonstrated that some mind and body therapies are effective at improving pain outcomes. While these therapies have shown promise, the efficacy of any single-modality treatment is typically modest, and finding a way to enhance the effect size of clinical outcomes is a crucially important goal. Multicomponent strategies may enhance the benefit to individuals by simultaneously targeting multiple pathways and may be more effective than a treatment used in isolation. To achieve generalizable results from trials, it is important to have a reproducible multicomponent intervention or algorithm of care that can be consistently delivered by different clinicians at different sites to conduct multisite trials to assess efficacy or effectiveness. Studies to develop and/or iteratively refine reproducible treatment protocols for multicomponent interventions for the management of pain are encouraged, which may use Delphi panels, computational modeling, or other methods. Studies to assess the acceptability or adherence to a protocolized multicomponent interventions that include complementary or integrative approaches for the management of pain.

Description of circumstances for which administrative supplements are available.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date – Applications may be submitted any time and will be reviewed and considered on a rolling basis. To be considered for funding in FY22, applications must be submitted no later than May 1, 2022, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-AT-22-003 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Only electronic submissions will be accepted for this funding opportunity. Use one of the methods described in PA-20-272. Paper submissions and applications submitted as attachments will be returned.
• Requests may be for one year of support only.
• Individual requests can be no more than $250,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts. Though supplement requests are not limited to one per award, we might consider substantial additional funding to an award as beyond the scope of the funded award.
• Applicants may apply for more than one supplement to a given parent grant/award, provided they are scientifically distinct.
• The Research Strategy section of the application is limited to 6 pages.
• As part of the application, investigators must submit an abstract of the proposed research that shows the relevance to the specified pain topic areas described in this NOTICE. Place the abstract in the Project Summary/Abstract section of the SF424 (R&R) form. The work may include pilot projects or resource development within the scope of the parent award.

Review Process

NCCIH will conduct administrative reviews of all applications.

Criteria:

• Is the work proposed within the scope of the active award?
• Is the work proposed focused on one of the seven specified pain research areas described in this NOTICE?
• Is the work likely to stimulate additional activity leading to progress on any, or all, of the specified pain research area?

Inquiries

Please direct all inquiries to the program officer listed in each NCCIH award.