The National Institutes of Health’s National Institute of Child Health and Human Development has awarded Duke Anesthesiology’s Andrea Nackley, PhD, director of The Nackley Lab, a 5-year, $3,846,094 R01 grant for her project, titled “Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe).”
Vestibulodynia (VBD) is a complex chronic vulvar pain condition that impairs the psychological, physical and sexual health of one in six reproductive-aged women in the United States. VBD is characterized by provoked vulvar pain that persists for at least three months in the absence of identifiable pathology, yet remains ineffectively treated (by standard trial-and-error approaches) due to the condition’s uncertain etiology and heterogeneous clinical manifestations.
Nackley and her co-investigators’ overall hypothesis is that two VBD-p and VBD-c subtypes have unique etiologies that can be distinguished by cytokine and microRNA profiles and will preferentially respond to peripheral, central, or combined treatments. They will conduct a multi-site clinical trial to 1) compare the efficacy of peripheral (lidocaine/estradiol cream), centrally-targeted (nortriptyline) and combined treatments in alleviating pain and improving patient-reported outcomes and 2) determine cytokine and microRNA biomarkers that predict treatment response in women with distinct VBD subtypes.
Through this work, Nackley and her research team expect to gain new insights into the mechanisms that drive pain perception and treatment response in two distinct VBD subtypes, and to determine the efficacy of peripheral, central and combined therapies in reversing this pain.
“Such findings will readily translate to improved patient care, says Nackley,“ permitting the millions of women with VBD, their partners and their clinicians to make more informed decisions about pain management.”