DysmenorrheaNCT07209566
A Research Study Exploring How Musculoskeletal Function and the Autonomic Nervous System Relate to Visceral Pain in Women With and Without Dysmenorrhea (Painful Periods).
A study testing Visceral Pain Stimulus in people with Dysmenorrhea and Dysmenorrhea Primary, run by Azusa Pacific University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Dysmenorrhea Primary, Visceral Pain
- What is being tested?
- Visceral Pain Stimulus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Fernandez, PT, DPT contact
United States1 site, 1 recruiting
- Recruiting
Azusa Pacific University
Azusa, California, 91702
Marta Cenac-Mehedinti, (626) 815-4633, mcenac@apu.edu
Louise Huang, (626) 815-4633, lhuang@apu.edu
About this study
Official title: The Effect of Vaginal Somatovisceral Pain on Hip Extension Mobility and Strength in Women at Mid-cycle With Dysmenorrhea vs. Controls: A Case-control Study
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.
Read the 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
- Being tested
- Visceral Pain Stimulus
- Keywords
- Effect of visceral organ pain on musculoskeletal and autonomic nervous system
- Medical subject headings
- Dysmenorrhea, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral Pain StimulusDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Visceral Pain Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of the lab testing session, approximately 60 minutes.
Secondary outcomes (1)
Interoceptive awareness
Participants will also be given the multidimensional analysis of interoceptive awareness, 2nd edition (MAIA-2), to assess their interoceptive awareness.
Measured: During the testing day, following physical pain stimulus.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azusa Pacific University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Steele, Azusa Pacific University
- Investigators
- Derrick Sueki, PT, PhD, DPT, Study chair, Azusa Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209566
- Sponsor's protocol ID
- 24-116
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared to protect confidentiality.
Publications
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.
PubMed 34126503Serrano-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.
PubMed 36359567Tu 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.
PubMed 23370073Tucker 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.
PubMed 22209423Van 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.
PubMed 33230131Yacubovich 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.
PubMed 31733762Wakefield 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.
PubMed 25562458
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vaginal Somatovisceral Pain on Hip Extension Mobility and Strength in Women at Mid-cycle With Dysmenorrhea vs. Controls: A Case-control Study
- ClinicalTrials.gov ID
- NCT07209566
- Acronym / sponsor ID
- 24-116
- Conditions
- Dysmenorrhea, Dysmenorrhea Primary, Visceral Pain, Menstrual Pain
- Keywords
- Effect of visceral organ pain on musculoskeletal and autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azusa Pacific UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visceral Pain Stimulus | Experimental | Diagnostic Test: Visceral Pain StimulusAll 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visceral Pain StimulusParticipants 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. | Diagnostic test | Visceral Pain Stimulus |
Primary outcome
Change in hip range of motion
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Interoceptive awareness
Time frame: During the testing day, following physical pain stimulus.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Background: PubMed 34126503Pacheco-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.
- Background: PubMed 36359567Serrano-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.
- Background: PubMed 23370073Tu 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.
- Background: PubMed 22209423Tucker 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.
- Background: PubMed 33230131Van 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.
- Background: PubMed 31733762Yacubovich 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.
- Background: PubMed 25562458Wakefield 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.
- Individual participant dataSharing planned: No. No IPD will be shared to protect confidentiality.
Related trials for Dysmenorrhea
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Active, not recruitingPhase 2
A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
Endometriosis
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Fernandez, PT, DPT contact
Derrick Sueki, PT, PhD, DPT study chair
Azusa Pacific University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral Pain Stimulus in people with Dysmenorrhea and Dysmenorrhea Primary, run by Azusa Pacific University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan M Steele, PT, DPT, PhD(c) (520-603-7913, msteele20@apu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hip range of motion (time frame: Change from baseline to immediately after the pain stimulus is given.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07209566, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.