Primary DysmenorrheaNCT04685343

Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents

A study testing Quantitative Sensory Testing and fMRI in people with Primary Dysmenorrhea, run by Mclean Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 19 years, women onlyHealthy volunteers can take part
Conditions the study is for: Primary Dysmenorrhea
What is being tested?: Quantitative Sensory Testing and fMRI
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2020to 24 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 19 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Female aged 13-19 years
Self-reported menstrual cycle averaging 22-35 days
Regular menstrual cycles for at least 6 months
Access to a smartphone or email
Right handed
Body Mass Index (BMI) of 35 or less

Show all 9Show fewer

Able to read and understand English
Ability and willingness to provide written informed assent/consent
Availability of a parent to provide written parental permission (for participants under age 18)

Who cannot join

Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)
Diagnosis of chronic pain condition (e.g., Irritable bowel syndrome (IBS), functional abdominal pain, interstitial cystitis/painful bladder syndrome)
Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions
Diagnosis of an eating disorder within the last 6 months
Current or past diagnosis of any psychotic disorder

Show all 14Show fewer

Currently pregnant
Self-reported weekly use of alcohol, cannabis, and/or other illegal substances
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
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). Potential participants who are being treated for cardiovascular disease(s) will be included pending discussion with the participant's primary physician
Developmental delay, diagnosis of autism, or significant cognitive impairment that may preclude understanding of study procedures
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
Significant fear of enclosed places (claustrophobia)

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Hospital
Belmont, Massachusetts, 02478

Other trials in United States

About this study

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.

Conditions: Primary Dysmenorrhea
Being tested: Quantitative Sensory Testing, fMRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quantitative Sensory TestingBehavioural
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).
fMRIOther
Functional magnetic resonance imaging (fMRI) session consisting of structural and functional brain scans.

Study groups in NCT04685343
Study group	Role	What they receive
fMRI and laboratory pain induction	Experimental	Not described Receives: Behavioral: Quantitative Sensory Testing; Other: fMRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Menstrual pain
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.
Measured: Baseline
Change in menstrual pain from baseline to 12-months post 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.
Measured: At baseline and 12 months after baseline
Change in bodily pain from baseline to 12-months post baseline
Change in the number of bodily locations endorsed as painful during the prior month.
Measured: At baseline and 12 months after baseline
Pressure pain sensitivity (PPS)
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.
Measured: At baseline
Pressure pain tolerance (PPT)
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.
Measured: At baseline
Trapezius pressure pain threshold (TPPTh)
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.
Measured: At baseline
Conditioned pain modulation (CPM)
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).
Measured: At baseline
Gray matter volume
Gray matter regional volume and surface area will be measured from images obtained during the fMRI session.
Measured: At baseline
White matter fiber tract values
Obtained from fiber tracking using images obtained during diffusion tensor imaging (DTI). Values represent anatomical connectivity of cortical and subcortical brain regions.
Measured: At baseline
Resting state networks
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.
Measured: At baseline

Secondary outcomes (10)

Change in menstrual pain from 12-months post baseline to 24-months post 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.
Measured: 12 months after baseline and 24 months after baseline
Change in bodily pain from 12-months post baseline to 24-months post baseline
Change in the number of bodily locations endorsed as painful during the prior month.
Measured: 12 months after baseline and 24 months after baseline
Salivary pro-inflammatory cytokines
Assessment of pro-inflammatory cytokines found in the saliva (e.g., IL-1 Beta, IL-6, IL-8, TNF-Alpha)
Measured: 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)
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.
Measured: 12 months after baseline
Change in conditioned pain modulation (CPM) from baseline to 12-months post 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.
Measured: At baseline and 12 months after baseline
Change in pressure pain sensitivity (PPS) from baseline to 12-months post 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.
Measured: At baseline and 12 months after baseline
Change in pressure pain tolerance (PPT) from baseline to 12-months post baseline
Change in the PPT described above between baseline and 12-months post baseline.
Measured: At baseline and 12 months after baseline
Change in gray matter volume from baseline to 12-months post baseline
Change in the gray matter regional volume and surface area obtained from images obtained during the fMRI session.
Measured: At baseline and 12 months after baseline
Change in white matter fiber tract values from baseline to 12-months post baseline
Change in the DTI-produced fiber tracking values, which represent anatomical connectivity of cortical and subcortical brain regions.
Measured: At baseline and 12 months after baseline
Change in resting state networks
Change in region-to-region connectivity strength of the regions of interest (i.e., salience, sensorimotor, emotional arousal, and default mode networks).
Measured: At baseline and 12 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202024 Dec 2025

First posted28 Dec 2020
Study start14 Dec 2020
Primary completion24 Dec 2025
Study completion24 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04685343
Sponsor's protocol ID: 2019P001729
Status last verified: Jan 2026
First submitted: 2 Dec 2020
Last updated: 22 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Payne LA, Handy AB, Seidman LC, Mitchell CM, Edwards RR. Multisensory sensitivity predicts menstrual pain and widespread pain trajectories over 12 months in adolescents with and without primary dysmenorrhea. Pain. 2026 Apr 1;167(4):943-951. doi: 10.1097/j.pain.0000000000003868. Epub 2025 Nov 24.
PubMed 41284472

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain

All Primary Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
ClinicalTrials.gov ID: NCT04685343
Acronym / sponsor ID: 2019P001729
Conditions: Primary Dysmenorrhea
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Mclean HospitalUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 14 Dec 2020 (actual)
Primary completion: 24 Dec 2025 (actual)
Study completion: 24 Dec 2025 (actual)
First posted: 28 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
fMRI and laboratory pain induction	Experimental	Behavioral: Quantitative Sensory Testing, Other: fMRI

Who may qualify

Ages: 13 to 19 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Female aged 13-19 years
Self-reported menstrual cycle averaging 22-35 days
Regular menstrual cycles for at least 6 months
Access to a smartphone or email
Right handed

Key exclusion criteria (14 listed)

Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)
Diagnosis of chronic pain condition (e.g., Irritable bowel syndrome (IBS), functional abdominal pain, interstitial cystitis/painful bladder syndrome)
Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions
Diagnosis of an eating disorder within the last 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quantitative Sensory TestingQuantitative 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).	Behavioural	fMRI and laboratory pain induction
fMRIFunctional magnetic resonance imaging (fMRI) session consisting of structural and functional brain scans.	Other	fMRI and laboratory pain induction

Primary outcome

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.
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.
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.
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.
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.
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.
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).
Gray matter volume
Time frame: At baseline
Gray matter regional volume and surface area will be measured from images obtained during the fMRI session.
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.
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.

10 secondary outcomes

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 bodily pain from 12-months post baseline to 24-months post baseline
Time frame: 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)
Trapezius pressure pain threshold (TPPTh)
Time frame: 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
Change in pressure pain sensitivity (PPS) from baseline to 12-months post baseline
Time frame: 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 gray matter volume from baseline to 12-months post baseline
Time frame: 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 resting state networks
Time frame: At baseline and 12 months after baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Derived from this study: PubMed 41284472Payne LA, Handy AB, Seidman LC, Mitchell CM, Edwards RR. Multisensory sensitivity predicts menstrual pain and widespread pain trajectories over 12 months in adolescents with and without primary dysmenorrhea. Pain. 2026 Apr 1;167(4):943-951. doi: 10.1097/j.pain.0000000000003868. Epub 2025 Nov 24.

Related trials for Primary Dysmenorrhea

Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Payne, PhD principal investigator

Mclean Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Quantitative Sensory Testing and fMRI in people with Primary Dysmenorrhea, run by Mclean Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menstrual pain (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.