60 Participants Needed

Visceral Pain Study for Menstrual Cramps

MM
JF
Overseen ByJennifer Fernandez, PT, DPT
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Azusa Pacific University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how women with painful menstrual cramps (dysmenorrhea) respond to pain and how their body systems connect to this pain. It aims to determine if these women exhibit different bodily responses compared to women without cramps. The research also examines whether awareness of body sensations (interoceptive awareness) affects this pain. Women who may be suitable for this trial have regular menstrual cycles, do not use hormonal birth control, and do not have chronic pain conditions. The study uses a visceral pain stimulus to assess these responses. As an unphased trial, this study offers a unique opportunity to contribute to understanding menstrual pain and its broader impacts.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be taking hormonal birth control.

What prior data suggests that this visceral pain stimulus is safe?

Research has shown that women with painful periods experience pain differently than those without. One study found that these women do not undergo major changes in their perception or management of pain from internal organs. This suggests that the internal pain used in trials is usually well-tolerated by participants.

In simpler terms, the treatment being tested involves a type of internal pain that has not caused unexpected or severe reactions in similar studies. While some discomfort is expected, as with any pain study, current research indicates that the risks are low.12345

Why are researchers excited about this trial?

Unlike standard treatments for menstrual cramps, which typically involve pain relievers like NSAIDs or hormonal therapies, the visceral pain stimulus offers a unique approach by assessing physical responses to pain. Researchers are excited about this method because it could provide insights into how menstrual pain affects the body's movement and heart rate variability. This could lead to a deeper understanding of pain mechanisms and potentially pave the way for more personalized treatments in the future.

What evidence suggests that this visceral pain stimulus is effective for studying menstrual cramps?

This trial will investigate the link between visceral pain and menstrual cramps by administering a visceral pain stimulus to all participants. Studies have shown that women with severe dysmenorrhea, or painful periods, feel deep muscle pain more intensely than those without this condition. Research suggests this increased sensitivity might result from changes in how their bodies process pain. Additionally, some women with dysmenorrhea may face a higher risk of developing long-term pelvic pain. The link between pain from internal organs and menstrual cramps remains under study, but early findings suggest that women who experience more pain from their organs may have worse menstrual pain. Understanding these pain mechanisms could lead to better treatments for menstrual cramps.26789

Who Is on the Research Team?

DS

Derrick Sueki, PT, PhD, DPT

Principal Investigator

Azusa Pacific University

Are You a Good Fit for This Trial?

This study is for women who experience painful periods (dysmenorrhea) and may also have chronic visceral or menstrual pain. Participants should be able to respond to a visceral pain stimulus during the trial.

Inclusion Criteria

I am a woman aged 18-36, not pregnant, not on hormonal birth control, with regular menstrual cycles.

Exclusion Criteria

Participants who have given birth within the preceding six months
Participants who are breastfeeding
Participants who are undergoing in-vitro fertilization treatments
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session
1 visit (in-person)

Instrumentation and Education

Participants fill out demographic information, complete VAS, receive LH test kit, and are educated on HRV measurement

1 session
1 visit (in-person)

Lab Testing

Participants undergo HRV measurement, hip extension testing, and visceral pain stimulus with barostat probe

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in hip range of motion, dorsiflexor strength, and heart rate variability

Approximately 60 minutes

What Are the Treatments Tested in This Trial?

Interventions

  • Visceral Pain Stimulus
Trial Overview The trial is investigating how women with painful periods react to a specific type of pain that comes from internal organs, compared to those without such pain. It looks at muscle and nervous system responses, as well as awareness of internal body sensations.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Visceral Pain StimulusExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Azusa Pacific University

Lead Sponsor

Trials
5
Recruited
200+

Citations

A multidimensional appraisal of early menstrual pain experienceA relationship between higher bladder/visceral pain and dysmenorrhea among youth may only be present in those with markedly worse visceral pain ...
Chronic Pain Risk Associated With Menstrual Period PainThe purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain ...
Visceral Pain Stimulus in Dysmenorrhea and ... - ICH GCPThe purpose of this clinical trial is to determine if women with dysmenorrhea demonstrate an increased musculoskeletal and autonomic nervous ...
Women With Dysmenorrhea Are Hypersensitive to ...These data show that women with severe primary dysmenorrhea, who experience monthly menstrual pain, are hyperalgesic to deep muscle pain compared to women ...
Abdominal skeletal muscle activity precedes spontaneous ...The goal of this study was to determine whether involuntary abdominal muscle activity precedes spontaneous episodes of menstrual cramping pain in dysmenorrheic ...
Abdominal skeletal muscle activity precedes spontaneous ...The goal of this study is to determine if involuntary abdominal muscle activity precedes spontaneous episodes of menstrual cramping pain in dysmenorrheic women.
Behavioural and neural responses to aversive visceral stimuli ...Dysmenorrhoea patients show unaltered perceptual and neural responses to experimental interoceptive stimuli. Despite limited sample size, these negative results ...
What we know about primary dysmenorrhea today: a critical ...Throughout the menstrual cycle, women with dysmenorrhea have an increased sensitivity to painful stimuli, however, it is unknown whether the increased ...
A multidimensional appraisal of early menstrual pain ...This study aimed to describe the initial menstruation experience and to evaluate the association of premenarchal psychosocial and sensory factors with the ...
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