Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02214550
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2014-08-08
Brief Title:
Chronic Pain Risk Associated With Menstrual Period Pain
Sponsor:
NorthShore University HealthSystem
Organization:
NorthShore University HealthSystem
Study Overview
Official Title:
Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRAMPP
Brief Summary:
The purpose of this study is to determine if some women with dysmenorrhea painful periods are at higher future risk of developing chronic pelvic pain CPP and if oral contraceptives OC can be used to reverse this chronic pain risk
Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ sensitization COS episodes The use of cyclical OCs to eliminate dysmenorrhea is expected to reduce COS and decrease the risk of developing CPP
Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ sensitization COS episodes The use of cyclical OCs to eliminate dysmenorrhea is expected to reduce COS and decrease the risk of developing CPP
Detailed Description:
Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations 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 QSTbladder pain measures studied in Aim 1 will be retested within the dysmenorrheaCOS 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
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 QSTbladder pain measures studied in Aim 1 will be retested within the dysmenorrheaCOS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK100368-01 | NIH | None | httpsreporternihgovquickSearch1R01DK100368-01 |