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

NCT07209566 | Recruiting

• 1 other identifier: 24-116
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Effect of visceral organ pain on musculoskeletal and autonomic nervous system

Outcome Measures

Primary Outcomes (3)

• Change in hip range of motion

  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 from baseline to immediately after the pain stimulus is given.

• Change in dorsiflexor strength

  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.

  From baseline to immediately after the pain stimulus.

• Heart Rate Variability

  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.

  From baseline to the end of the lab testing session, approximately 60 minutes.

Secondary Outcomes (1)

• Interoceptive awareness

  During the testing day, following physical pain stimulus.

Study Arms (1)

Visceral Pain Stimulus

EXPERIMENTAL

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.

Diagnostic Test: Visceral Pain Stimulus

Interventions

Visceral Pain Stimulus 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.

Visceral Pain Stimulus

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women are eligible for this study because it requires a vaginal canal and a uterus.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Azusa Pacific University: lead

Study Sites (1)

Azusa Pacific University

Azusa, California, 91702, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 34126503 BACKGROUND

• 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.

  PMID: 36359567 BACKGROUND

• 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.

  PMID: 23370073 BACKGROUND

• 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.

  PMID: 22209423 BACKGROUND

• 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.

  PMID: 33230131 BACKGROUND

• 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.

  PMID: 31733762 BACKGROUND

• 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.

  PMID: 25562458 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Visceral Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Nociceptive Pain

Study Officials

• Derrick Sueki, PT, PhD, DPT

  Azusa Pacific University

  STUDY CHAIR

Central Study Contacts

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

CONTACT

520-603-7913; msteele20@apu.edu

Jennifer Fernandez, PT, DPT

CONTACT

jfernandez@apu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)