Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
195

Summary

Conditions
  • Chronic Pain
  • Cystitis, Interstitial
  • Dysmenorrhea
  • Endometriosis
  • Migraine Disorders
  • Pelvic Pain
  • Visceral Pain
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only females

Description

Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokines producing moderate to severe pelvic pain in more than 20% of reproductive-age women. One out of every five of those women in turn will develop chronic pelvic pain (CPP), yet women without dysm...

Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokines producing moderate to severe pelvic pain in more than 20% of reproductive-age women. One out of every five of those women in turn will develop chronic pelvic pain (CPP), yet women without dysmenorrhea rarely report CPP. CPP disorders such as irritable bowel syndrome (IBS) and painful bladder syndrome (PBS) can cause severe, unrelenting pain due to a lack of effective treatments. This study consists of 2 aims. Aim #1: To determine if dysmenorrhea with concomitant bladder pain sensitivity exhibits neurophysiological features consistent with established CPP. Women with chronic pain or dysmenorrhea without COS will be used as controls. Quantitative sensory testing (QST) and a noninvasive bladder pain test that investigators validated previously be used to determine whether impairments in descending inhibition and pelvic sensitivity are responsible for vulnerability to COS in women with dysmenorrhea. EEG will be recorded to look for differences in brain activity in response to sensory stimulation between participants cohorts. Aim #2: To differentiate the individual contributions of circulating sex hormones and repeated sensitizing events (painful menses) on descending and peripheral mechanisms of bladder pain. The same QST/bladder pain measures studied in Aim #1 will be retested within the dysmenorrhea+COS group following a one-year randomized trial of cyclical OCs vs. continuous OCs vs. no treatment. An observational arm of PBS participants will receive continuous OCs and serve as controls.

Locations

Evanston, Illinois, 60201
Evanston, Illinois, 60201

Tracking Information

NCT #
NCT02214550
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
  • Principal Investigator: Frank Tu, MD, MPH NorthShore University HealthSystem
  • Frank Tu, MD, MPH NorthShore University HealthSystem