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

NCT ID: NCT07209566

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-04-01

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.

Conditions

Dysmenorrhea; Dysmenorrhea Primary; Visceral Pain; Menstrual Pain

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Visceral Pain Stimulus

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azusa Pacific University

OTHER

Sponsor Role: lead

Responsible Party

Megan Steele

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derrick Sueki, PT, PhD, DPT

Role: STUDY_CHAIR

Azusa Pacific University

Locations

Azusa Pacific University

Azusa, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

msteele20@apu.edu

520-603-7913

Jennifer Fernandez, PT, DPT

Role: CONTACT

jfernandez@apu.edu

Facility Contacts

Marta Cenac-Mehedinti

Role: primary

mcenac@apu.edu

(626) 815-4633

Louise Huang

Role: backup

lhuang@apu.edu

(626) 815-4633

References

Pacheco-Carroza EA. Visceral pain, mechanisms, and implications in musculoskeletal clinical practice. Med Hypotheses. 2021 Aug;153:110624. doi: 10.1016/j.mehy.2021.110624. Epub 2021 Jun 6.

Reference Type: BACKGROUND

PMID: 34126503 (View on PubMed)

Serrano-Imedio A, Calvo-Lobo C, Casanas-Martin C, Garrido-Marin A, Pecos-Martin D. Myofascial Pain Syndrome in Women with Primary Dysmenorrhea: A Case-Control Study. Diagnostics (Basel). 2022 Nov 7;12(11):2723. doi: 10.3390/diagnostics12112723.

Reference Type: BACKGROUND

PMID: 36359567 (View on PubMed)

Tu FF, Epstein AE, Pozolo KE, Sexton DL, Melnyk AI, Hellman KM. A noninvasive bladder sensory test supports a role for dysmenorrhea increasing bladder noxious mechanosensitivity. Clin J Pain. 2013 Oct;29(10):883-90. doi: 10.1097/AJP.0b013e31827a71a3.

Reference Type: BACKGROUND

PMID: 23370073 (View on PubMed)

Tucker K, Larsson AK, Oknelid S, Hodges P. Similar alteration of motor unit recruitment strategies during the anticipation and experience of pain. Pain. 2012 Mar;153(3):636-643. doi: 10.1016/j.pain.2011.11.024. Epub 2011 Dec 29.

Reference Type: BACKGROUND

PMID: 22209423 (View on PubMed)

Van Oudenhove L, Kragel PA, Dupont P, Ly HG, Pazmany E, Enzlin P, Rubio A, Delon-Martin C, Bonaz B, Aziz Q, Tack J, Fukudo S, Kano M, Wager TD. Common and distinct neural representations of aversive somatic and visceral stimulation in healthy individuals. Nat Commun. 2020 Nov 23;11(1):5939. doi: 10.1038/s41467-020-19688-8.

Reference Type: BACKGROUND

PMID: 33230131 (View on PubMed)

Yacubovich Y, Cohen N, Tene L, Kalichman L. The prevalence of primary dysmenorrhea among students and its association with musculoskeletal and myofascial pain. J Bodyw Mov Ther. 2019 Oct;23(4):785-791. doi: 10.1016/j.jbmt.2019.05.006. Epub 2019 May 14.

Reference Type: BACKGROUND

PMID: 31733762 (View on PubMed)

Wakefield CB, Halls A, Difilippo N, Cottrell GT. Reliability of goniometric and trigonometric techniques for measuring hip-extension range of motion using the modified Thomas test. J Athl Train. 2015 May;50(5):460-6. doi: 10.4085/1062-6050-50.2.05. Epub 2015 Jan 6.

Reference Type: BACKGROUND

PMID: 25562458 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

24-116

Identifier Type: -

Identifier Source: org_study_id