Dysmenorrhea, Pain
Conditions
Keywords
cross-organ sensitivity, bladder pain, NSAID, visceral pain
Brief summary
The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. Finally, a battery of quantitative sensory tests and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain.
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 experience chronic pelvic pain (CPP) which may be in part due to cross-organ neural sensitization. In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than \*\*\* use.
Interventions
DRUGNaproxen
Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Sponsors
Endeavor Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Reproductive-age women (age 18-45) with dysmenorrhea * Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers * Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament * Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)
Exclusion criteria
* Presence of active pelvic or abdominal malignancies (primary or metastatic) * Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) * Active genitourinary infection in the last four weeks * Unable to read or comprehend the informed consent in English * Unwilling to complete study procedures * Presence of hypertension or risk for developing hypertension * Unwillingness to take naproxen and/or placebo * Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function) * Formal urological diagnosis such as overactive bladder or bladder pain syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menstrual Pain | 6-8 months | Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score. |
| Change in Participant Bladder Pain Sensitivity From Baseline | 6-8 months | 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 baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between April 2018 and December 2019 from our registry and other studies.
Participants by arm
| Arm | Count |
|---|---|
| Primary Dysmenorrhea We will look at the effects of naproxen 500mg use on pain starting just before and during menses.
Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Primary Dysmenorrhea |
|---|---|
| Age, Continuous | 24.5 years STANDARD_DEVIATION 6.3 |
| Bladder Pain | 16.5 Visual Analog Scale 0-100 STANDARD_DEVIATION 16.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Menstrual Pain | 6.0 Numerical rating scale STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Change in Menstrual Pain
Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score.
Time frame: 6-8 months
Population: Some participant data were missing due to attrition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Dysmenorrhea | Change in Menstrual Pain | 4.1 score on a scale | Standard Deviation 2.4 |
Comparison: Paired t-tests were used to compare worst menstrual pain rating across diary day (0-10 numeric rating scale) from baseline and at 6-8 maths followup.p-value: <0.0001t-test, 2 sided
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 baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure.
Time frame: 6-8 months
Population: Some participant data were missing due to attrition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Dysmenorrhea | Change in Participant Bladder Pain Sensitivity From Baseline | 10.7 score on a scale | Standard Deviation 10.6 |
p-value: 0.119t-test, 2 sided