Réponse aux anti-inflammatoires non stéroïdiens (AINS) et sensibilisation centrale à la douleur chez les femmes atteintes de dysménorrhée
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
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Belmont, Massachusetts, États-Unis, 02478
- McLean Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Sodium Naproxen first
Participants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle. |
One dose of 550mg sodium naproxen taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). One dose of placebo capsule taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). |
|
Expérimental: Placebo first
Participants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle. |
One dose of 550mg sodium naproxen taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). One dose of placebo capsule taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Non-steroidal Anti-inflammatory Drug (NSAID) Response
Délai: 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. Possible range: -20 (min) to 20 (max). The value of each intervention separately can be associated with a better or worse outcome, as indicated below. The value of this measure is not independently clinically meaningful (i.e., not related to better or worse outcomes) as it is the result of comparing an individual to themself. Negative values indicate that the participant demonstrated more response to naproxen than they did to placebo; positive values indicate that the participant demonstrated more response to placebo than they did to naproxen. |
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
|
|
Urinary Naproxen Concentration
Délai: Four hours after taking the dose (either Naproxen or placebo).
|
Concentration of naproxen measured in the urine sample. Measured in nanograms of Naproxen Glucuronide per mg creatinine. Value is not independently clinically meaningful (i.e., not related to better or worse outcomes). |
Four hours after taking the dose (either Naproxen or placebo).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Placebo Cycle Response
Délai: 4 hours after dose is taken.
|
Change in menstrual pain rating on a 0 (no pain) to 10 (worst pain possible) numeric rating scale before and after the dose is taken. Calculated by subtracting the pre-dose rating from the post-dose rating. Possible range: -10 (min) to 10 (max). Lower scores indicate better outcome. |
4 hours after dose is taken.
|
|
Non-steroidal Anti-inflammatory Drug (NSAID) Cycle Response
Délai: 4 hours after dose is taken.
|
Change in menstrual pain rating on a 0 (no pain) to 10 (worst pain possible) numeric rating scale before and after the dose is taken. Calculated by subtracting the pre-dose rating from the post-dose rating. Possible range: -10 (min) to 10 (max). Lower scores indicate better outcome. |
4 hours after dose is taken.
|
|
Urinary PGF2α Concentration
Délai: Four hours after taking the dose (either Naproxen or placebo).
|
Concentration of prostaglandin F2α (PGF2α) measured in the urine sample. Value is not independently clinically meaningful (i.e., not related to better or worse outcomes). |
Four hours after taking the dose (either Naproxen or placebo).
|
|
Urinary PGE Concentration
Délai: Four hours after taking the dose (either Naproxen or placebo).
|
New information since initial submission indicated that this outcome measure (Prostaglandin E; PGE) would not be detectable in urine. No PGE analyses were conducted. |
Four hours after taking the dose (either Naproxen or placebo).
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Laura Payne, PhD, Mclean Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- La douleur
- Manifestations neurologiques
- Processus pathologiques
- Douleur pelvienne
- Troubles menstruels
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Dysménorrhée
- Produits chimiques organiques
- Hydrocarbures
- Hydrocarbures, cyclique
- Naphtalenes
- Hydrocarbures aromatiques polycycliques
- Hydrocarbures, aromatique
- Composés polycycliques
- Acides naphtalénécètiques
- Naproxène
Autres numéros d'identification d'étude
- 2023P001489
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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