Impact of OMT on the Symptoms of Dysmenorrhea

NCT07849140 | Recruiting

• 1 other identifier: P26IRB013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will span two months per participant and include a baseline evaluation, a control period, the treatment itself, and an after-treatment evaluation. After getting informed consent, participants will be asked to fill out surveys about their menstrual cycles and health histories, including pain levels, timing, and the types and length of symptoms they may have. Participants will then go through a month control period where they will have their cycle without any osteopathic manipulative treatment (OMT) being given, followed by a standard osteopathic exam. They will be asked to fill out all surveys again at this time. They will then go through OMT 3-7 days before their next period. After their second cycle, they will complete a final survey. Participants' pain and symptoms will be assessed at each time point by comparing survey responses and checking for improvement. The goal of this study is to see whether osteopathic manipulative treatment reduces pain and eases symptoms, and whether this approach is practical for future studies.

Conditions

Dysmenorrhea

Keywords

OMT; Dysmenorrhea; Osteopathic Manipulative Treatment; Osteopathic Manipulative Medicine

Outcome Measures

Primary Outcomes (1)

• Menstrual Pain Numeric Scale Rating (NRS)

  The NRS is a widely used and validated tool for measuring menstrual pain in subjects participating in clinical trials. This self-reported pain scale ranges from 0 to 10. A score of zero indicates no pain, and a score of 10 indicates the worst possible pain.

  Baseline, at the end of Cycle 1 (each cycle is 28 days), and at the end of Cycle 2 (an additional 28 days).

Secondary Outcomes (3)

• Premenstrual Syndrome Scale (PMSS) Scores

  Baseline, at the end of Cycle 1 (each cycle is 28 days), and at the end of Cycle 2 (an additional 28 days).

• Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) Score

  Baseline, at the end of Cycle 1 (each cycle is 28 days), and at the end of Cycle 2 (an additional 28 days).

• Modified Quantitative Analgesic Questionnaire (QAQ)

  Baseline, at the end of Cycle 1 (each cycle is 28 days), and at the end of Cycle 2 (an additional 28 days).

Study Arms (1)

Control time period vs. OMT Intervention period

EXPERIMENTAL

This single-arm study consists of participants undergoing a 1-month control period with no intervention prior to their menstrual cycle, during which they don't alter their daily lives. This is followed by a second month in which they undergo a menstrual cycle with OMT intervention 3-7 days before menstruation.

Procedure: Osteopathic Manipulative Treatment (OMT)

Interventions

Osteopathic Manipulative Treatment (OMT) PROCEDURE

Manual applied therapeutic techniques to correct somatic dysfunction and asymmetry of the lumbar and cervical pelvis and sacrum. This includes soft-tissue, articulatory, muscle energy, myofascial release, and High-Velocity Low-Amplitude (HVLA).

Control time period vs. OMT Intervention period

Eligibility Criteria

• Age: 20 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female Western University of Health Sciences students, faculty, or staff who experience dysmenorrhea symptoms.

You may not qualify if:

• Individuals who are pregnant or breastfeeding.
• Individuals under the age of 20 and over the age of 51.
• Individuals with a history of endometriosis or PCOS.
• Individuals with a history of thyroid conditions.
• Individuals who change or plan ot change birth control during the course of the study.
• Individuals receiving outside OMT or physical therapy treatment.

Sponsors & Collaborators

• Western University of Health Sciences: lead

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766-1854, United States

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• David Redding, DO

  Western University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Redding, DO

CONTACT

909-469-5281; dredding@westernu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of NMM/OMM and Family Medicine

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 30, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study is published.
• Access Criteria: All interested research professionals.

Locations

US (1)