NOT-AT-22-007: Notice of Special Interest: NCCIH High Priority Pain Research

Notice of Special Interest: NCCIH High Priority Pain Research

Notice Number:

NOT-AT-22-007

Key Dates

Release Date:

December 20, 2021

First Available Due Date:

February 07, 2022

Expiration Date:

December 15, 2022

Related Announcements

PA-19-055 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-19-056 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-19-091 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-19-053 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-19-054 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-19-092 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required

PAR-21-240 - Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)

PAR-19-134 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed)

PAR-20-154 - Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

The National Center for Complementary and Integrative Health (NCCIH) is inviting applications to focus on the following pain related research topic areas in response to this NOTICE.

Only the following research areas will be considered as responsive to this NOTICE:

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. 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 pain sensation. Understanding the mechanisms underlying the innervation of fascia as well as muscles may help uncover novel therapeutic targets for pain management. 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. 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 studies 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) data 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-relieving effects. 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 managing 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 single 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 using PAR-21-240 and PAR-19-134 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 are also encouraged.

7) Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth. Increasingly, researchers are incorporating mobile health (mHealth) technologies to remotely deliver interventions, including mindfulness, deep breathing, progressive muscle relaxation, and other complementary and integrative health interventions. These remotely delivered interventions may utilize phone delivery, app-based approaches, video delivery, web-based platforms, wearable devices and/or new technologies. The rapid expansion of mHealth technologies makes it possible to digitally transmit participant data from remote areas to centrally based researchers and interventionists, deliver feedback, and capture all interactions in a database. Remotely delivered interventions utilizing mHealth tools/technologies have the potential to increase the reach of complementary and integrative health interventions, and many commercially available mHealth approaches already exist. However, rigorously designed research is needed to test the usefulness and safety of remotely delivered complementary and integrative health interventions for pain management. For clinical trials to address this need, they must be well designed and appropriately powered to test clinically relevant hypotheses. Applications should have a clear and compelling rationale, a rigorous empirical basis, strong feasibility and safety data, and scientific premise to conduct a large-scale remotely delivered efficacy or effectiveness trial.

Application and Submission Information

This Notice applies to applications with due dates on or after February 5, 2022 and subsequent receipt dates through December 15, 2022. Submit applications for this Notice using one of the below Funding Opportunity Announcements (FOAs). Investigators should submit applications as responses to the active solicitation and application due dates will correspond to what is listed in the active FOAs. All instructions for the Parent Announcements must be followed.

Submit applications for this initiative using one of the below FOAs: