The Effect of OMM in the Treatment of Primary Dysmenorrhea Symptoms

NCT05208476 | Completed

• 1 other identifier: BHS-1521
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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 for the duration of symptom relief with OMT. Throughout the study, participants will be using the "Menstrual Distress Questionnaire" to document complaints. A MYOTON will be utilized to measure any musculoskeletal correlations with symptoms and pre- and post- OMM treatment effects. Description analysis will be done using participant responses to see the effect of OMT on musculoskeletal complaints and associated symptoms of primary dysmenorrhea.

Conditions

Dysmenorrhea Primary

Outcome Measures

Primary Outcomes (1)

• Menstrual Distress Questionnaire

  Changes in subject reported primary dysmenorrhea symptoms using validated Menstrual Distress Questionnaire

  3 months

Secondary Outcomes (1)

• Muscle Stiffness and Muscle Tone

  3 months

Study Arms (1)

Participants

EXPERIMENTAL

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.

Procedure: Osteopathic manipulative medicine

Interventions

Osteopathic manipulative medicine PROCEDURE

A set of hands-on techniques used by osteopathic physicians to help diagnose, treat and prevent illness or disease.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complaints of menstrual-related pain over past 2 years
• Regular menstrual cycles, with menstruation lasting at least 2-5 days for past 2 years
• Occurrence of a regular menstrual cycle within past 40 days
• Complaint of dysmenorrhea symptoms with a severity of at least 5/10 on the Visual Analog Scale

You may not qualify if:

• Presence of Pelvic Pathology (endometriosis, leiomyomata, adenomyosis, pelvic inflammatory disease, etc)
• Known Hormonal Imbalance (PCOS, Ovarian Disorder, etc)
• Oral Contraceptive Use
• Presence of IUD (Copper or Hormone Eluting)
• Oligomenorrhea/Amenorrhea
• Pregnancy
• Under age 18 yo
• Positive COVID-19 serological testing

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

Riland Academic Health Care Center

Old Westbury, New York, 11545, United States

Location

Related Publications (3)

• Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.

  PMID: 24695505 BACKGROUND

• Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.

  PMID: 26346058 BACKGROUND

• Emo A, Blumer J. Neuromuscular Manipulation Improves Pain Intensity and Duration in Primary Dysmenorrhea. J Am Osteopath Assoc. 2018 Jul 1;118(7):488-489. doi: 10.7556/jaoa.2018.109. No abstract available.

  PMID: 29946673 BACKGROUND

Study Officials

• Sheldon Yao, DO

  New York Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 26, 2022
• Study Start: February 16, 2022
• Primary Completion: December 30, 2023
• Study Completion: April 16, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)