Are you healthy and looking to help advance medical science?

You may be eligible to participate in a chronic pain clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a chronic pain clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Chronic Pain Clinical Trial in Evanston IL

NCT02214550 | Phase 4 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a chronic pain clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a chronic pain clinical study, and could be compensated for your time.

Completed

Female

18 - 45

Years old

This study has recruited 353 Participants

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.

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Details for the study

Brief Title

Chronic Pain Risk Associated With Menstrual Period Pain

Official Title

Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain

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.

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 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.

Treatments and/or Procedures

Continuous microgestin 1 20

Continuous OC use - Pills containing hormones will be taken every day for 1 year

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Change in Participant Bladder Pain Sensitivity From Baseline.

Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in pain. Bladder pain ratings at first urge will be used at the outcome measure.

0 (baseline), 6 month, and 12 month visits

Secondary

Differences in EEG Recorded Cortical Activity Among Participants

We obtained the peak alpha frequency at the right and left parietal occipital electrodes and averages of the two sides were assessed at Baseline, 6 month, and 12 Month to determine whether differences in resting state brain activity at parieto-occipital electrode sites are affected by oral contraceptives

Baseline, 6 months and 12 months

Secondary

Change in Quantitative Sensory Testing (QST) Parameters Regarding Pelvic Hyperalgesia From Baseline

Results from the QST testing performed at initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in sensitivity from baseline. Specifically, measure reported is the pressure pain threshold in newtons observed at the transition from pressure to pain transvaginally at the 12 o'clock position (anteriorly against the bladder). Lower values (pressure) indicate greater sensitivity.

0 (baseline), 6 months and 12 months

Study Criteria

Inclusion Criteria:

All

  -  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:

All

  -  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.