Recruiting

Observational Study

Sponsor:

Azusa Pacific University

Code:

NCT07209566

Conditions

Dysmenorrhea

Dysmenorrhea Primary

Visceral Pain

Menstrual Pain

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Visceral Pain Stimulus

Study Details

Brief summary:

The purpose of this clinical trial is to determine if women with dysmenorrhea demonstrate an increased musculoskeletal and autonomic nervous system response to a painful visceral stimulus compared to controls. A secondary aim is to determine if interoceptive awareness moderates this relationship. The designed methodology aims to elucidate the intricate connections between the interoceptive and musculoskeletal systems in pain perception among female participants, providing valuable insights into the underlying mechanisms of interoceptive pain and functional musculoskeletal changes.

Conditions

Dysmenorrhea

Dysmenorrhea Primary

Visceral Pain

Menstrual Pain

Study ID

NCT07209566

Start date

Aug 1, 2025

Status verified date

Sep, 2025

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria: Non-pregnant women, not taking hormonal birth control, between the ages of 18 and 36 who report regular menstrual cycles are eligible for the study Exclusion Criteria: Participants will be excluded if they are currently pregnant or, have given birth within the preceding six months, are breastfeeding, or are undergoing in-vitro fertilization treatments. Exclusions also include those who have had abdominal, lumbar, or pelvic surgery within the preceding 12 months, suffer from a chronic pain condition, have an active genitourinary infection, are incontinent of bowel or bladder, or have been diagnosed with prolapse of a pelvic organ, severe labral pathology, femoral acetabular impingement (FAI), interstitial cystitis, endometriosis, pelvic inflammatory disease, irritable bowel syndrome, or other pelvic pathology. Participants reporting a cycle length of less than 28 days or longer than 35 days, those with a history of sexual assault, and those who are anovulatory without hormonal BC or amenorrheic will also be excluded.

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Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Visceral Pain Stimulus

All participants will receive a visceral pain stimulus and have their hip range of motion and strength tested before and after the stimulus. Their heart rate variability will be measured throughout.

Interventions

Visceral Pain Stimulus

Participants will receive a visceral pain stimulus while being monitored for heart rate variability (HRV), and will have hip mobility and dorsiflexor strength assessed before and after.

Primary outcome measure

  • Change in hip range of motion [ Time Frame: Change from baseline to immediately after the pain stimulus is given. ]
  • Change in dorsiflexor strength [ Time Frame: From baseline to immediately after the pain stimulus. ]
  • Heart Rate Variability [ Time Frame: From baseline to the end of the lab testing session, approximately 60 minutes. ]

Central Contacts and Locations

Central contacts

Megan M Steele, PT, DPT, PhD(c)

520-603-7913msteele20@apu.edu

Jennifer Fernandez, PT, DPT

jfernandez@apu.edu

Locations

Azusa Pacific University

Recruiting

Azusa, California, United States, 91702

Contacts

More Information

Sponsor

Azusa Pacific University

Last update posted

Oct 7, 2025

Last verified

Sep, 2025

Keywords

  • Effect of visceral organ pain on musculoskeletal and autonomic nervous system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Azusa Pacific University on 2025-10-07.