A Research Study Exploring How Musculoskeletal Function and the Autonomic Nervous System Relate to Visceral Pain in Women With and Without Dysmenorrhea (Painful Periods).

Not Applicable

Recruiting

• Conditions: Dysmenorrhea; Dysmenorrhea Primary; Visceral Pain; Menstrual Pain

• Registration Number: NCT07209566
• Lead Sponsor: Azusa Pacific University

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.

Detailed Description

A case-control trial will be conducted. The experimental group will consist of at least 30 subjects with a pain rating during menstruation greater than or equal to 4. The control group will be age-matched participants with pain rating less than or equal to 3 during menstruation. The study will consist of one information and instrumentation session followed by one lab session. During the initial session, participants will fill out demographic information and the VAS to allow for stratification into experimental or control groups. They will be given an LH test kit and educated on how to perform LH tests. They will be asked to track their menstrual cycle on an app or online journal that can be shared with investigators. They will be asked to download an HRV app and be taught how to measure their HRV using their phone's camera. They will be instructed to take a one-minute measure of HRV once daily for 30 days beginning on the first day of their period.

On lab day, participants will be asked to remove clothing and put on a gown, booties, and disposable underwear to wear during testing. They will be led into a temperature-controlled environment where they will complete the testing. Testing includes HRV baseline measurement for 5 minutes, heartbeat counting for 3 short sessions (25, 35, and 45 seconds), and confidence about scoring. Next, an investigator with a certification to complete internal pelvic exams will ask the participant to lie on the table, and a student investigator will take the baseline measurement of their hip extension. The side being measured will be randomized, and only one side will be tested on each participant.

Next, the barostat probe will be inserted into the vaginal canal. The barostat will be inflated once to allow the participant to experience the sensation of the balloon. The probe will then be inflated until the participant reports the sensation of pain. The amount of distension in the balloon will be recorded, and hip mobility will again be measured. 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.

Study Timeline

• Study Start: 2025-08-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2026-09-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in hip range of motion	Change from baseline to immediately after the pain stimulus is given.	The change in hip range of motion from baseline to after a visceral pain stimulus is a primary outcome measure of this study. This measurement will be compared between groups to determine if those with dysmenorrhea react to a painful stimulus differently compared to those without dysmenorrhea.
Change in dorsiflexor strength	From baseline to immediately after the pain stimulus.	The change in strength of ankle dorsiflexors on the contralateral side of the hip being measured will also be assessed. This will be measured before and after the visceral pain stimulus to determine if there is a change. This measurement will be compared between groups to determine if those with dysmenorrhea react to a painful stimulus differently compared to those without dysmenorrhea.
Heart Rate Variability	From baseline to the end of the lab testing session, approximately 60 minutes.	Heart rate variability will be measured throughout, and several time frames will be marked, including a 5-minute baseline within a 15-minute session, at the time of insertion of the probe, and at the pain stimulus, to determine if those with dysmenorrhea react to a painful stimulus differently compared to those without dysmenorrhea.

Secondary Outcome Measures

Name	Time	Method
Interoceptive awareness	During the testing day, following physical pain stimulus.	Participants will also be given the multidimensional analysis of interoceptive awareness, 2nd edition (MAIA-2), to assess their interoceptive awareness.

Trial Locations

Locations (1)

Azusa Pacific University; 🇺🇸 Azusa, California, United States