Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents

January 21, 2026 updated by: Laura Payne, Mclean Hospital
The study will use primary dysmenorrhea (PD; menstrual pain without an identified organic cause) as a model to examine biomarkers associated with menstrual and non-menstrual bodily pain in adolescent girls, ages 13-19. Participants will undergo extensive phenotyping including pain inhibition testing and multimodal neuroimaging to obtain indices brain structure and function at baseline and 12 months later. Menstrual pain severity and non-menstrual bodily pain will be assessed monthly for 24 months. Aims of the study are: 1) to identify the central mechanisms of PD using measures of pain inhibition and brain structure and connectivity of sensorimotor, default, emotional arousal, and salience networks, 2) to determine deficits in pain inhibition and alterations in brain structure and network connectivity that predict the one-year developmental trajectories of menstrual pain and non-menstrual bodily pain, and 3) to identify the dynamic relationship between alterations in pain inhibition and brain structure and connectivity with symptom change in menstrual pain and non-menstrual bodily pain. We hypothesize that deficits in endogenous pain inhibition and alterations in brain structure, connectivity, and function of regional networks will be positively associated with menstrual pain severity ratings at baseline and predict the trajectory of menstrual and non-menstrual bodily pain over 2 years. The results are expected to identify specific mechanisms and characteristics that predict the transition from acute/cyclical pain to persistent or chronic pain, which will support the development of therapies to prevent the transition from recurrent to chronic pain in adulthood.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female aged 13-19 years
  2. Self-reported menstrual cycle averaging 22-35 days
  3. Regular menstrual cycles for at least 6 months
  4. Access to a smartphone or email
  5. Right handed
  6. Body Mass Index (BMI) of 35 or less
  7. Able to read and understand English
  8. Ability and willingness to provide written informed assent/consent
  9. Availability of a parent to provide written parental permission (for participants under age 18)

Exclusion Criteria:

  1. Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
  2. Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)
  3. Diagnosis of chronic pain condition (e.g., Irritable bowel syndrome (IBS), functional abdominal pain, interstitial cystitis/painful bladder syndrome)
  4. Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions
  5. Diagnosis of an eating disorder within the last 6 months
  6. Current or past diagnosis of any psychotic disorder
  7. Currently pregnant
  8. Self-reported weekly use of alcohol, cannabis, and/or other illegal substances
  9. Use of stimulants (including methamphetamine and/or medications for the treatment of ADHD) or opioids in the previous 3 months. Participants who use other analgesics will be included but will be requested to not take these analgesics within the previous 24 hours of the laboratory session
  10. History of pelvic inflammatory disease or sexually transmitted disease
  11. 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). Potential participants who are being treated for cardiovascular disease(s) will be included pending discussion with the participant's primary physician
  12. Developmental delay, diagnosis of autism, or significant cognitive impairment that may preclude understanding of study procedures
  13. Presence of certain ferromagnetic appliance or implants (braces, retainers, spacers, wires, screws, etc.) in the mouth or any other body part that may be a contraindication for the magnetic resonance imaging (MRI) scanner
  14. Significant fear of enclosed places (claustrophobia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: fMRI and laboratory pain induction
Behavioral: Quantitative Sensory Testing
Quantitative sensory testing (QST) consisting of 4 pain induction and sensory sensitivity tasks (i.e., pressure applied to the thumbnail, arms, shoulders, and lower abdomen, a cold water task, and one video-watching task).
Other: fMRI
Functional magnetic resonance imaging (fMRI) session consisting of structural and functional brain scans.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Menstrual pain
Time Frame: Baseline
Rating of average pain during the first two days of the most recent menstrual period on a 0 (no pain) to 10 (worst pain possible) numeric rating scale.
Baseline
Change in menstrual pain from baseline to 12-months post baseline
Time Frame: At baseline and 12 months after baseline
Change in the rating of average pain during the first two days of the most recent menstrual period on a 0 (no pain) to 10 (worst pain possible) numeric rating scale.
At baseline and 12 months after baseline
Change in bodily pain from baseline to 12-months post baseline
Time Frame: At baseline and 12 months after baseline
Change in the number of bodily locations endorsed as painful during the prior month.
At baseline and 12 months after baseline
Pressure pain sensitivity (PPS)
Time Frame: At baseline
The pain rating [on a 0 (no pain) to 100 (worst pain possible) numeric rating scale] of a 5-second, 2.0 kg/cm2 application of pressure to the right thumbnail bed.
At baseline
Pressure pain tolerance (PPT)
Time Frame: At baseline
The last rated pressure delivered in a series of increasing pressure applications to the right thumbnail bed. Each application of pressure lasts for 5 seconds. The pressure sequence is terminated when the participant reaches their individual tolerance and decides to stop, when the participant reaches the safety maximum amount of pressure, or when the participant rates the pressure >=80 on a 0 (no pain) to 100 (worst pain possible) numeric rating scale.
At baseline
Trapezius pressure pain threshold (TPPTh)
Time Frame: At baseline
The amount of pressure, applied by a pressure algometer to the participant's trapezius muscle, needed for the pressure stimulus to first feel painful to the participant.
At baseline
Conditioned pain modulation (CPM)
Time Frame: At baseline
Conditioned pain modulation (CPM) assesses pain inhibition. CPM is calculated as the change in the TPPTh 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).
At baseline
Gray matter volume
Time Frame: At baseline
Gray matter regional volume and surface area will be measured from images obtained during the fMRI session.
At baseline
White matter fiber tract values
Time Frame: At baseline
Obtained from fiber tracking using images obtained during diffusion tensor imaging (DTI). Values represent anatomical connectivity of cortical and subcortical brain regions.
At baseline
Resting state networks
Time Frame: At baseline
Calculated from images obtained during resting state fMRI. Region-to-region connectivity indices are obtained by correlating fMRI time series corrected for physiological noise and motion. Region-to-region connectivity strength of the regions of interest (i.e., salience, sensorimotor, emotional arousal, and default mode networks) will be assessed for each participant.
At baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in menstrual pain from 12-months post baseline to 24-months post baseline
Time Frame: 12 months after baseline and 24 months after baseline
Change in the rating of average pain during the first two days of the most recent menstrual period on a 0 (no pain) to 10 (worst pain possible) numeric rating scale.
12 months after baseline and 24 months after baseline
Change in bodily pain from 12-months post baseline to 24-months post baseline
Time Frame: 12 months after baseline and 24 months after baseline
Change in the number of bodily locations endorsed as painful during the prior month.
12 months after baseline and 24 months after baseline
Salivary pro-inflammatory cytokines
Time Frame: Three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)
Assessment of pro-inflammatory cytokines found in the saliva (e.g., IL-1 Beta, IL-6, IL-8, TNF-Alpha)
Three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)
Trapezius pressure pain threshold (TPPTh)
Time Frame: 12 months after baseline
The amount of pressure, applied by a pressure algometer to the participant's trapezius muscle, needed for the pressure stimulus to first feel painful to the participant.
12 months after baseline
Change in conditioned pain modulation (CPM) from baseline to 12-months post baseline
Time Frame: At baseline and 12 months after baseline
Alterations in pain inhibition will be assessed via the direction of the change (i.e., improvement in pain inhibition, worsening of pain inhibition, and stable pain inhibition) as well as the magnitude of the change.
At baseline and 12 months after baseline
Change in pressure pain sensitivity (PPS) from baseline to 12-months post baseline
Time Frame: At baseline and 12 months after baseline
Change in the pain rating [on a 0 (no pain) to 100 (worst pain possible) numeric rating scale] of a 5-second, 2.0 kg/cm2 application of pressure to the right thumbnail bed.
At baseline and 12 months after baseline
Change in pressure pain tolerance (PPT) from baseline to 12-months post baseline
Time Frame: At baseline and 12 months after baseline
Change in the PPT described above between baseline and 12-months post baseline.
At baseline and 12 months after baseline
Change in gray matter volume from baseline to 12-months post baseline
Time Frame: At baseline and 12 months after baseline
Change in the gray matter regional volume and surface area obtained from images obtained during the fMRI session.
At baseline and 12 months after baseline
Change in white matter fiber tract values from baseline to 12-months post baseline
Time Frame: At baseline and 12 months after baseline
Change in the DTI-produced fiber tracking values, which represent anatomical connectivity of cortical and subcortical brain regions.
At baseline and 12 months after baseline
Change in resting state networks
Time Frame: At baseline and 12 months after baseline
Change in region-to-region connectivity strength of the regions of interest (i.e., salience, sensorimotor, emotional arousal, and default mode networks).
At baseline and 12 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mclean Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Payne, PhD, McLean Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019P001729

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings