Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents

NCT ID: NCT04685343

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2025-12-24

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

fMRI and laboratory pain induction

Group Type: EXPERIMENTAL

Quantitative Sensory Testing

Intervention Type: BEHAVIORAL

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).

fMRI

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: BEHAVIORAL

fMRI

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laura Payne

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Payne, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

References

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. 2025 Nov 24. doi: 10.1097/j.pain.0000000000003868. Online ahead of print.

Reference Type: DERIVED

PMID: 41284472 (View on PubMed)

Other Identifiers

2019P001729

Identifier Type: -

Identifier Source: org_study_id