Clinical trial NCT05900336: Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea
Official title: Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dysmenorrhea
Menstrual Pain
Non-steroidal Anti-inflammatory Drug
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Endeavor Health
First posted: 2023-06-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.


Eligibility criteria: Inclusion Criteria:

1. Female aged 18-50 years
2. Menstrual pain rated at least 6/10 on a 0 (no pain) to 10 (worst pain possible) NRS for all menstrual cycles in the previous 6 months
3. Regular menstrual cycles over the past year (at least 9 in the previous 12 months)
4. Self-reported menstrual cycle averaging 22-35 days
5. Access to a smartphone and email, and willing/able to receive text messages
6. Able to read and understand English
7. Ability and willingness to provide written informed consent.

Exclusion Criteria:

1. Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
2. Variable levels of menstrual pain in the previous 6 months
3. Self-reported symptoms consistent with a chronic pain condition (e.g., pain in any body area lasting longer than 3 months) or previous diagnosis of a chronic pain condition
4. Currently pregnant or breastfeeding
5. History of pelvic inflammatory disease or sexually transmitted disease
6. Acute illness or injury that would potentially impact pain task performance (e.g., fever, flu symptoms) or that affect sensitivity of the extremities (e.g., Reynaud's disease)
7. Allergy to naproxen or having a health condition that contradicts use of naproxen or affects naproxen metabolism (e.g., kidney disease)
8. History of high blood pressure or anemia (due to possible complications from NSAID use).

Primary outcomes:
measure: Overall NSAID response
timeFrame: 4 hrs after taking dose during the 2nd medicated menstrual period (i.e., 4 hrs after the first occurrence of pain >= 6 on the 0-10 scale after menstrual bleeding has started during the 2nd medicated menstrual period); # of days varies by participant
measure: Urinary naproxen concentration
timeFrame: Four hours after taking the dose (either Naproxen or placebo).
measure: Conditioned pain modulation (CPM)
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
Secondary outcomes:
measure: Placebo cycle response
timeFrame: 4 hours after dose is taken.
measure: NSAID cycle response
timeFrame: 4 hours after dose is taken.
measure: Urinary PGF2α concentration
timeFrame: Four hours after taking the dose (either Naproxen or placebo).
measure: Urinary PGE concentration
timeFrame: Four hours after taking the dose (either Naproxen or placebo).
measure: pain50
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: pain70
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Pressure pain sensitivity (PPS)
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Pressure pain tolerance (PPT)
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Trapezius pressure pain sensitivity (TPPS)
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Time to bladder first sensation
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Pain at bladder first sensation
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Time to bladder first urge
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Pain at bladder first urge
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Time to bladder maximum tolerance
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
measure: Pain at bladder maximum tolerance
timeFrame: At baseline (i.e., during the in-person study visit, during days 8-14 of the menstrual cycle, prior to either of the medication cycles)
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Laura Payne, PhD
role: PRINCIPAL_INVESTIGATOR
References: