Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall NSAID response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged 18-50 years
- •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
- •Regular menstrual cycles over the past year (at least 9 in the previous 12 months)
- •Self-reported menstrual cycle averaging 22-35 days
- •Access to a smartphone and email, and willing/able to receive text messages
- •Able to read and understand English
- •Ability and willingness to provide written informed consent.
排除标准
- •Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
- •Variable levels of menstrual pain in the previous 6 months
- •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
- •Currently pregnant or breastfeeding
- •History of pelvic inflammatory disease or sexually transmitted disease
- •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)
- •Allergy to naproxen or having a health condition that contradicts use of naproxen or affects naproxen metabolism (e.g., kidney disease)
- •History of high blood pressure or anemia (due to possible complications from NSAID use).
研究组 & 干预措施
Sodium Naproxen first
Participants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle.
干预措施: Sodium Naproxen (Drug)
Sodium Naproxen first
Participants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle.
干预措施: Placebo (Drug)
Placebo first
Participants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle.
干预措施: Sodium Naproxen (Drug)
Placebo first
Participants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall NSAID response
时间窗: 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
NSAID response will be calculated by comparing change in menstrual pain ratings following NSAID to change in menstrual pain ratings following placebo. Calculated by subtracting the placebo cycle response measure from the NSAID cycle response measure. This will result in a single measure indicative of the degree of NSAID response, while controlling for placebo effects
Urinary naproxen concentration
时间窗: Four hours after taking the dose (either Naproxen or placebo).
Concentration of naproxen measured in the urine sample.
Conditioned pain modulation (CPM)
时间窗: 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)
Conditioned pain modulation (CPM) assesses pain inhibition. CPM is calculated as the change in pain50 between when the pressure is applied by itself (test stimulus) and when it is applied while the participant's hand is submerged in cold water (conditioning stimulus).
次要结局
- Urinary PGF2α concentration(Four hours after taking the dose (either Naproxen or placebo).)
- Placebo cycle response(4 hours after dose is taken.)
- NSAID cycle response(4 hours after dose is taken.)
- Time to bladder first sensation(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))
- Urinary PGE concentration(Four hours after taking the dose (either Naproxen or placebo).)
- pain50(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))
- Pressure pain tolerance (PPT)(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))
- Pain at bladder first sensation(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))
- Time to bladder first urge(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))
- Pain at bladder first urge(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))
- Pain at bladder maximum tolerance(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))
- pain70(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))
- Trapezius pressure pain sensitivity (TPPS)(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))
- Pressure pain sensitivity (PPS)(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))
- Time to bladder maximum tolerance(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))
研究者
Laura Payne
Assistant Professor
Mclean Hospital