R01HD117068

UNDERSTANDING VULVODYNIA: USING MACHINE-LEARNING-BASED MODELING TO IDENTIFY FACTORS ASSOCIATED WITH RESOLUTION AND PERSISTENCE OF VULVAR PAIN - PROJECT SUMMARY VULVODYNIA AFFECTS 8-15% OF WOMEN AND IS ONE AMONG THE IDENTIFIED CHRONIC OVERLAPPING PAIN CONDITIONS (COPCS). THE CONDITION IS POORLY UNDERSTOOD BY CLINICAL PROVIDERS; PEOPLE SEEKING CARE FOR VULVODYNIA SEE A MEAN OF 3 PROVIDERS BEFORE RECEIVING A DIAGNOSIS. VULVODYNIA IS DIFFERENT THAN MANY CHRONIC PAIN CONDITIONS BECAUSE IT IS OFTEN HIGHLY ASSOCIATED WITH SEXUAL FUNCTIONING AND RESULTS IN A CONFLICT BETWEEN THE DESIRE FOR INTIMACY AND PAIN. SIMILAR TO OTHER COPCS, VULVODYNIA IS ASSOCIATED WITH HIGHER LEVELS OF DEPRESSION, HOWEVER IT IS UNCLEAR WHETHER THE PRESENCE OF DEPRESSION INFLUENCES PROGRESSION OR PERSISTENCE OF SYMPTOMS. PEOPLE WITH VULVODYNIA FEEL SHAME AND STIGMA AROUND THEIR DIAGNOSIS, AND HAVE DIFFICULTY DISCUSSING IT WITH PARTNERS, PROVIDERS, AND FRIENDS. IN OUR EXPERIENCE, PATIENTS WITH VULVODYNIA WANT TO KNOW WHETHER AND WHEN THEIR PAIN WILL GO AWAY AND WHETHER THE PRESENCE OF OTHER COMORBID CONDITIONS LIKE DEPRESSION WILL IMPACT THE TRAJECTORY OF THEIR PAIN, HOWEVER THERE ARE LIMITED LONGITUDINAL DATA ON WHICH TO BASE ANSWERS TO THOSE QUESTIONS. WE WILL PROSPECTIVELY COLLECT DATA ON MULTIPLE COMPONENTS OF THE VULVODYNIA PAIN EXPERIENCE AND PERSISTENCE OF SYMPTOMS OVER 2 YEARS. A COHORT OF 200 WOMEN AGES 18-45 WITH VULVODYNIA WILL BE FOLLOWED, WITH MONTHLY SURVEYS AND THREE SEPARATE IN-PERSON ASSESSMENTS OVER TWO YEARS INCLUDING AT EACH TIMEPOINT: 1) STANDARDIZED QUESTIONNAIRES INCLUDING HEAL COMMON DATA ELEMENTS, ASSESSMENT OF TREATMENT MODALITIES, AND PHYSICAL EXAM, 2) COLLECTION OF VAGINAL SWABS FOR MICROBIOME AND INFLAMMATION, 3) QUANTITATIVE SENSORY TESTING (QST) TO ASSESS CENTRAL SENSITIZATION, AND 4) 2 WEEKS OF ECOLOGIC MOMENTARY ASSESSMENT (EMA) AND PASSIVE ACTIVITY DATA COLLECTION FROM A MOBILE DEVICE USING THE OPEN SOURCE MINDLAMP PLATFORM. WE WILL THEN USE STATISTICAL MODELS AND MACHINE LEARNING TO 1) DEFINE THE VARIABILITY OVER TIME OF PAIN AND ASSOCIATED PREDICTORS, 2) IDENTIFY HOW DEPRESSIVE SYMPTOMS IMPACT ASSOCIATIONS BETWEEN PREDICTORS AND PAIN, AND 3) IDENTIFY PREDICTORS OF PAIN RESOLUTION. WE WILL TRAIN THE MATHEMATICAL MODEL USING DATA FROM THE FIRST 100 PARTICIPANTS AND WILL VALIDATE THE MODEL WITH DATA FROM THE SECOND 100 PARTICIPANTS. THE MODEL WILL ALSO BE USED TO TEST WHAT MODIFIABLE FACTORS HAVE THE LARGEST IMPACT ON PAIN TRAJECTORIES. COLLECTION OF BOTH SYMPTOMATOLOGY AND A WIDE RANGE OF PHENOTYPIC PATIENT CHARACTERISTICS IN A LONGITUDINAL MANNER WILL FOR THE FIRST TIME CAPTURE AN INTEGRATED VIEW OF HOW PAIN EXPERIENCE, DEPRESSIVE SYMPTOMS, AND CENTRAL SENSITIZATION COEVOLVE IN THE PROGRESSION OF VULVODYNIA.

The General Hospital Corporation

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Massachusetts United States

State-Wide

HEAL Initiative: Understanding Individual Differences in Human Pain Conditions (R01 - Clinical Trial Optional) (RFA-NS-24-021)