The National Institutes of Health (NIH) intends to support the development of innovative methods for quantitative evaluation of myofascial tissues for pain management involving research participants using a two-phase grant funding mechanism.
Donor Name: National Institutes of Health (NIH)
State: All States
County: All Counties
Territory: Commonwealth of Puerto Rico, Guam, American Samoa, U.S. Virgin Islands and Commonwealth of Northern Mariana Islands
Type of Grant: Grant
Deadline: 09/01/2023
Size of the Grant: $4 million
Grant Duration: 5 years
Details:
Purpose
This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to improve treatment for opioid misuse and addiction and enhance pain management. This notice of funding opportunity (NOFO) seeks research applications that will develop quantitative measures to facilitate the development of future biomarkers of myofascial tissues and assess their abilities to detect changes in myofascial tissues across a variety of pain management interventions, manipulations, or therapies. Promising quantitative measures may be based on minimally invasive imaging technologies, electrophysiological recordings, integration of multiparametric imaging and electrophysiology approaches, or their integration with other markers (e.g., immune factors, genomic markers, physiological factors) through multiscale modeling or machine learning analysis. The first phase, funded by the R61, will provide funding for up to 3 years to develop quantitative measures that can differentiate abnormal myofascial tissue from healthy tissues using cross-sectional correlations with clinical signs/symptoms. In addition, the R61 phase should include planning activities for the R33 phase. The second phase, funded under the R33, will support studies to assess the ability of the quantitative measures developed in the R61 phase to detect changes to myofascial tissues across a variety of pain interventions in rigorous, longitudinal clinical studies. The combined R61/R33 cannot exceed 5 years. Transition from the R61 to the R33 phase of the award will be administratively reviewed and will be determined based on successful completion of “Transition Milestones” that need to be clearly specified in the R61 phase application.
Research Objectives and Requirements
This NOFO aims to achieve two major objectives using the R61/R33 phased approach.
Objective 1 (R61 Phase): Observational Studies and Planning for the R33 Phase (up to three years)
- The primary objective of the R61 phase is to identify and develop quantitative measures for research participants that can differentiate abnormal myofascial tissues from healthy tissues in observational study designs and through cross-sectional correlations with clinical signs/symptoms. In addition, the investigators should include efforts directed towards the team building and planning for the R33 phase clinical trial during this first phase.
- Potential quantitative technologies for developing such quantitative measures include, but are not restricted to:
- Structural imaging (e.g., magnetic resonance [MR], ultrasound), addressing improved spatial resolution needed to visualize micro-structures such as muscle spindles that may be involved in myofascial pain
- Functional assessments (e.g., elastography) to quantify soft tissue mobility and biomechanical properties (e.g., stiffness, viscosity, shear plane mobility)
- Quantitative evaluation of tissue metabolism, perfusion, oxygenation, and fatty infiltration (e.g., positron emission tomography [PET], optical, photoacoustic, or MR spectroscopic imaging or electrophysiological measurements of muscle, sensory, motor, and autonomic peripheral activity)
- Multimodal, multiparametric, and multiscale approaches integrating different types of measurements, including dynamic changes of tissue targets
- Of particular interest to this reissue are non-proton (e.g., Sodium, Phosphorus, etc.) and multi nuclear MR imaging and spectroscopy, Molecular imaging (e.g., CEST MRI, pH measurements), whole body imaging, nerve imaging, thermal imaging, and measurements of brain-to-muscle communication
Objective 2 (R33 Phase): Interventional Studies
- The primary objective of the R33 phase is to build on the quantitative measures identified and developed in the R61 phase to test their abilities to detect changes in myofascial tissues undergoing one or more pain management intervention(s) or manipulation(s) in randomized, controlled longitudinal studies of patients with pain. Additionally, changes in patient-reported outcomes in response to existing and putative treatments to relieve myofascial pain are of particular interest. Specifically, identified quantitative measures developed in the R61 phase should be measured at baseline and during and after treatments to measure changes in response to interventions. In addition, baseline measures should be evaluated for their ability to identify or predict patients who are more likely to have pain relief or better pain relief and other favorable effects after the intervention. Also, clinical pain measures should be assessed before (at baseline) and after the interventions
- The sensitivity and specificity of putative quantitative measures should be assessed during the R33 phase
- Current empirical treatment of myofascial pain includes acupuncture or “dry needling,” targeted injections (e.g., lidocaine, glucose or saline solutions), and manual therapies, while additional putative treatment may include drugs and devices, or other non-pharmacologic approaches. For the reissue of this NOFO, applicants must propose a rigorous, longitudinal clinical study using an intervention, manipulation, or therapy that is currently used clinically to treat pain conditions involving myofascial tissues to test the effects of the intervention on the quantitative measure(s) developed in the R61 phase.. Investigators are encouraged (but not limited) to choose one (or more) of the following treatments or therapies for the R33 study:
- Physical force-based manipulations, such as manual therapies (e.g., massage therapy, soft tissue mobilization, strain-counterstrain techniques, joint mobilization, muscle energy techniques, high-velocity/low-amplitude thrusting, spinal manipulation, osteopathic manipulation, gua sha) and stretching-based physical activities (e.g., yoga, tai chi, dance therapy)
- Thermotherapies (e.g., heating or cooling/cryotherapy)
- Dry needling or acupuncture
- Targeted injection therapies (e.g., lidocaine injection therapy)
- Other local tissue manipulations
- If another intervention, manipulation, or therapy not listed above is chosen, the application should describe evidence supporting the relevance of the intervention’s effect on the myofascial unit and how this therapy or intervention will produce measurable changes that can be measured using the proposed quantitative assessment developed in the R61 phase. Applicants are not expected to provide efficacy data to justify the choice of the intervention/treatment for the R33 phase.
Grant Priorities
- This NOFO supports the identification and development of objective quantitative measures of myofascial tissues. Both phases must include appropriate human subject research. Animal model studies are not allowed in response to this NOFO
- All applications must include quantitative assessments of at least one component of the myofascial unit in both the R61 and R33 phase studies using minimally invasive or non-invasive technologies. If an application does not include any quantitative assessment of the myofascial component, it would be deemed non-responsive to this NOFO
- Highly invasive technologies and biomarkers will be deprioritized. The R61/R33 award is primarily intended to stimulate the development and adaptation of innovative imaging technologies and similar quantitative assessment methods to differentiate between healthy and diseased states of myofascial tissues involved in pain in human subjects. Consequently, strong applications are expected to propose a well-conceived plan for up to 3 years of funding that focuses on research activities developing these technologies and quantitative assessment methods in the R61 phase. The description of the R33 phase may be brief and should specify the intended interventions and clinical pain population to be studied to test the biomarkers developed in the R61 phase. Note, the R33 phase research plan may be modified based on the outcomes of the R61 study and will need approval from the HEAL program team
- Research applications submitted under this NOFO are likely to cover a large group of pain conditions involving myofascial tissues. The following pain conditions will be prioritized in this reissue:
- Temporomandibular disorders
- Cancer Pain
- Headache
- Pelvic pain
- Diffuse pain (e.g., Fibromyalgia, Sickle cell disease pain)
- Pain in special populations (e.g., children, persons with physical and intellectual disabilities, hypermobility disorders, physically or mentally disabled, dementia patients, women of reproductive age, pregnant and lactating individuals, and health disparity populations [i.e. racial/ethnic groups, sexual and gender minorities, underserved rural and socioeconomically disadvantaged populations, people with limited English proficiency], etc.)
Funding Information
- The HEAL Initiative intends to commit an estimated total of $4 million in FY 2024 to fund up to 5 awards. Awards pursuant to this funding opportunity are contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
- Award Period: The scope of the project should determine the project period for each phase. The maximum period of the combined R61 and R33 phases is 5 years, with up to 3 years for the R61 phase.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
For more information, visit Grants.gov.
