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Manual Therapy
Osteopathic Manipulative Medicine for Menstrual Cramps
N/A
Recruiting
Led By Sheldon Yao, DO
Research Sponsored by New York Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is studying whether Osteopathic Manipulative Medicine (OMM) can reduce musculoskeletal complaints and symptoms related to primary dysmenorrhea (painful menstruation).
Who is the study for?
This trial is for women experiencing painful menstruation (dysmenorrhea) with regular menstrual cycles and pain severity of at least 5/10. They must have had these symptoms consistently over the past two years. Women who are pregnant, under 18, using oral contraceptives or IUDs, or have pelvic pathologies like endometriosis or hormonal imbalances such as PCOS are excluded.Check my eligibility
What is being tested?
The study tests if Osteopathic Manipulative Medicine (OMM), a type of physical therapy involving body manipulation, can reduce back and abdominal pain associated with dysmenorrhea. Participants will receive OMM treatments twice a week for one menstrual cycle and report their symptom changes throughout.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects from OMM may include temporary discomfort, soreness or bruising at manipulation sites. Serious side effects are rare but could involve injury to soft tissues or nerves.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Menstrual Distress Questionnaire
Secondary outcome measures
Muscle Stiffness and Muscle Tone
Trial Design
1Treatment groups
Experimental Treatment
Group I: ParticipantsExperimental Treatment1 Intervention
All subjects will be observed for one menstrual cycle then given Osteopathic manipulative treatment during the second menstrual cycle. During the third menstrual cycle, participants will continue to be observed.
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Who is running the clinical trial?
New York Institute of TechnologyLead Sponsor
51 Previous Clinical Trials
2,051 Total Patients Enrolled
Sheldon Yao, DOPrincipal InvestigatorNew York Institute of Technology
3 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a regular period in the last 40 days.You are taking birth control pills.You have experienced menstrual pain in the last 2 years.You have period pain that rates at least 5 out of 10 on a pain scale.You have had regular periods that last at least 2-5 days for the past 2 years.You have a condition in your pelvic area such as endometriosis, leiomyomata, adenomyosis, or pelvic inflammatory disease.You have a known hormonal imbalance, such as PCOS or ovarian disorder.You have an intrauterine device (IUD) in place.You have irregular or absent menstrual periods.You have tested positive for COVID-19 antibodies.
Research Study Groups:
This trial has the following groups:- Group 1: Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the population participating in this experiment?
"Affirmative. According to the records hosted on clinicaltrials.gov, this medical trial is presently enrolling patients - it was posted in mid-February of 2022 and last updated around that same time as well. The study calls for 20 participants from a single location."
Answered by AI
Is recruitment for this research endeavor still underway?
"Absolutely, the information housed on clinicaltrials.gov alludes to this medical trial being actively looking for candidates; first posted in February 16th 2022 and most recently updated on the same day. The study is searching for 20 people from 1 site."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Riland Academic Health Care Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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