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NCT05208476 · ClinicalTrials.gov registry record · NA
The Effect of OMM in the Treatment of Primary Dysmenorrhea Symptoms
A NA study, sponsored by New York Institute of Technology.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT05208476: Completed NA study, sponsored by New York Institute of Technology.
NCT05208476 is a NA study that has completed, run by New York Institute of Technology. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05208476, a NA study, has completed, sponsored by New York Institute of Technology.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Primary dysmenorrhea or simply painful menstruation is a disorder that 45-90% of women experience to varying degrees. The most prominent symptom of dysmenorrhea is crampy suprapubic pain occurring prior to menstruation, closely followed by low back pain, headache, depression, diarrhea, fatigue, nausea, and vomiting. Primary dysmenorrhea cannot be attributed to a specific physiological reason, whereas secondary dysmenorrhea may be due to other gynecological disorders. For symptom management, most patients self-medicate with over the counter nonsteroidal anti-inflammatory drugs. While most non-pharmacological treatments for dysmenorrhea such as heat therapy, yoga, acupuncture and massage do not show promising data on reducing symptoms, neuromuscular manipulation has been shown to improve pain intensity and duration of dysmenorrhea. In this study, the investigator's primary outcome is to assess whether Osteopathic Manipulative Medicine (OMM) is effective at reducing the musculoskeletal complaints of dysmenorrhea especially pain in the back, abdominal, lower extremity and head regions. In addition, secondary outcomes include any changes in nausea, bloating, diarrhea, fatigue/general malaise, depressed/anxious mood, irritability and mental fog with OMM treatment. Since OMM involves manipulation of various parts of the body, the investigators hypothesize that OMM will assist in freeing tissue tension and promoting adequate blood and lymphatic flow to decrease stasis and inflammatory mediators present in the tissues to relieve pain. Female subjects with dysmenorrhea will be enrolled in this study. During the initial phase (first menstrual cycle), a baseline of participants' dysmenorrhea symptoms will be established. In the next phase (2nd menstrual cycle), participants will be given Osteopathic Manipulative Treatment (OMT) according to findings on Osteopathic structural exams twice a week for 4 weeks. In the final phase (3rd menstrual cycle), participants will be monitored
Primary Outcome
Changes in subject reported primary dysmenorrhea symptoms using validated Menstrual Distress Questionnaire
Interventions
- PROCEDURE Osteopathic manipulative medicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-02-16 |
| Est. Completion | 2024-04-16 |
| Phase | NA |
What the finished NCT05208476 record still lists
NCT05208476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Osteopathic manipulative medicine is the first listed.
NCT05208476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05208476 about?
NCT05208476 is a clinical study titled "The Effect of OMM in the Treatment of Primary Dysmenorrhea Symptoms". Primary dysmenorrhea or simply painful menstruation is a disorder that 45-90% of women experience to varying degrees. The most prominent symptom of dysmenorrhea is crampy suprapubic pain occurring prior to menstruation, closely followed by low back pain, headache, depression, diarrhea, fatigue, naus...
What is the current status of trial NCT05208476?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2022-02-16. Estimated completion is 2024-04-16.
What interventions are being tested in trial NCT05208476?
The interventions under investigation include: Osteopathic manipulative medicine (PROCEDURE).
Who is sponsoring clinical trial NCT05208476?
This trial is sponsored by New York Institute of Technology, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05208476's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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