Chronic Pain Risk Associated With Menstrual Period Pain
NCT ID: NCT02214550
Last Updated: 2023-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
353 participants
INTERVENTIONAL
2014-07-31
2021-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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D+COS-no OC
Ten participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
No interventions assigned to this group
D+COS-cyclic microgestin 1/20
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
cyclic microgestin 1/20
Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
D+COS-continuous microgestin 1/20
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20
Continuous OC use - Pills containing hormones will be taken every day for 1 year
PBS-continuous microgestin 1/20
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
continuous microgestin 1/20
Continuous OC use - Pills containing hormones will be taken every day for 1 year
No Intervention: Pain Discovery Aim
255 Reproductive-age women (18-45) will be identified and divided into 5 groups
Healthy Controls Chronic Pain (Positive Controls) Dysmenorrhea (D) Dysmenorrhea with Cross Organ Sensitization (D+COS) Painful bladder syndrome (PBS)/interstitial cystitis (IC) After a screening, dysmenorrhea with COS and PBS participants will be compared with controls. Daily Diaries will be completed for 1-3 months. During the luteal phase of the participants' menstrual cycle or a predetermined time, participants will complete aim #1 testing consisting of a battery of questionnaires, bladder sensitivity testing, quantitative sensory testing (QST), a blood draw and EEG testing. All participants will also complete a yearly follow-up questionnaire for 5 years.
No interventions assigned to this group
Interventions
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cyclic microgestin 1/20
Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
continuous microgestin 1/20
Continuous OC use - Pills containing hormones will be taken every day for 1 year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Reproductive age women (18-45)
For dysmenorrhea and D+COS group only:
* Participants must have had regular (22-45 day) menstrual cycles over at least a two month period preceding testing
Exclusion Criteria
* presence of active pelvic or abdominal malignancies (primary or metastatic)
* active genitourinary infection in the last four weeks
* unable to read or comprehend the informed consent in English
* unwilling to undergo pelvic examination/testing
* presence of hypertension or risk for developing hypertension, and
For dysmenorrhea and D+COS group only:
* absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) unwilling to take either cyclic or combined OCs
* unwilling to withdraw from OCs for two months prior to the sensory testing study visit.
18 Years
45 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Endeavor Health
OTHER
Responsible Party
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Frank Tu
Division Director, Gynecological Pain and Minimally Invasive Surgery, Department of Obstetrics and Gynecology
Principal Investigators
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Frank Tu, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Locations
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NorthShore University Health System
Evanston, Illinois, United States
Countries
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References
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Tu FF, Epstein AE, Pozolo KE, Sexton DL, Melnyk AI, Hellman KM. A noninvasive bladder sensory test supports a role for dysmenorrhea increasing bladder noxious mechanosensitivity. Clin J Pain. 2013 Oct;29(10):883-90. doi: 10.1097/AJP.0b013e31827a71a3.
Tu FF, Fitzgerald CM, Kuiken T, Farrell T, Norman Harden R. Vaginal pressure-pain thresholds: initial validation and reliability assessment in healthy women. Clin J Pain. 2008 Jan;24(1):45-50. doi: 10.1097/AJP.0b013e318156db13.
Zondervan KT, Yudkin PL, Vessey MP, Jenkinson CP, Dawes MG, Barlow DH, Kennedy SH. Chronic pelvic pain in the community--symptoms, investigations, and diagnoses. Am J Obstet Gynecol. 2001 May;184(6):1149-55. doi: 10.1067/mob.2001.112904.
Westling AM, Tu FF, Griffith JW, Hellman KM. The association of dysmenorrhea with noncyclic pelvic pain accounting for psychological factors. Am J Obstet Gynecol. 2013 Nov;209(5):422.e1-422.e10. doi: 10.1016/j.ajog.2013.08.020. Epub 2013 Aug 22.
Brotzner CP, Klimesch W, Doppelmayr M, Zauner A, Kerschbaum HH. Resting state alpha frequency is associated with menstrual cycle phase, estradiol and use of oral contraceptives. Brain Res. 2014 Aug 19;1577(100):36-44. doi: 10.1016/j.brainres.2014.06.034. Epub 2014 Jul 7.
Kmiecik MJ, Tu FF, Clauw DJ, Hellman KM. Multimodal hypersensitivity derived from quantitative sensory testing predicts pelvic pain outcome: an observational cohort study. Pain. 2023 Sep 1;164(9):2070-2083. doi: 10.1097/j.pain.0000000000002909. Epub 2023 Apr 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EH13-094
Identifier Type: -
Identifier Source: org_study_id
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