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NCT07849140NARecruiting

Impact of OMT on the Symptoms of Dysmenorrhea

Western University of Health Sciences

Start Date

4/30/2026

Completion Date

12/31/2027

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.

Detailed Description

This prospective longitudinal pilot study will last two months per subject. It uses a within-subjects design (pre-post comparison with an internal control phase). The study includes a pre-intervention assessment, a control phase, the intervention, and a post-intervention assessment. After obtaining informed consent, subjects will complete an initial baseline survey assessing menstrual cycle characteristics, including pain intensity (0-10 scale), duration, symptom types, and frequency. The baseline survey will include screening questions regarding subjects' medical history to identify conditions associated with secondary dysmenorrhea (e.g., endometriosis, PCOS, thyroid disorders, or other relevant gynecologic conditions). These questions will be used to ensure that participants do not meet any exclusion criteria indicating secondary dysmenorrhea. Subjects will also be asked to confirm that they are not currently receiving other therapeutic interventions (such as OMT, physical therapy, or other manual treatments) for dysmenorrhea during the study period. This is intended to ensure that the study evaluates the effects of a single standardized OMT intervention without interference from concurrent treatments and to establish an accurate baseline comparison between the control and intervention menstrual cycles. Following completion of the baseline survey of menstrual cycle characteristics, subjects will enter a control period consisting of one complete menstrual cycle without osteopathic manipulative treatment (OMT). During the control period, participants will complete an initial survey before menses, followed by a post-menstrual survey at the end of this untreated cycle. Subjects who report new exclusion criteria during the study period will be withdrawn from participation. Following the control phase, subjects will undergo a standardized osteopathic structural exam, followed by OMT, approximately 3 to 7 days before the menstrual cycle. After the intervention and after the completion of menses, subjects will complete a post-menstrual exit survey. Upon completion of the study, all surveys will be compared, and changes in the data will be analyzed. The structural exam and OMT will include: A normal, osteopathic structural exam of the lumbar, pelvis, and sacrum (assessing for lumbar spinal asymmetry, tenderness, and hypertonicity of paraspinal muscles, pelvic landmarks; ASIS, PSIS, pubic symphysis, sacral sulcus depth, and Inferior lateral angles of the sacrum). OMT will include soft tissue of the lumbar spine, articulatory and muscle energy techniques, and possible HVLA (quick adjustments of dysfunctional joints). Data will be de-identified and analyzed using descriptive statistics and within-subject comparisons (paired t-tests or nonparametric equivalents) to assess changes in pain and symptom scores between the control and intervention phases. The primary outcomes will include reductions in average pain intensity and symptom burden, while secondary outcomes will assess analgesic use. Results will inform feasibility and potential efficacy for future larger-scale studies. Descriptive statistics will include means, standard deviations, medians, and frequencies for all variables. Paired t-tests or, if necessary, the Wilcoxon signed-rank test will be used to compare control and OMT intervention phase pain and symptom scores. Repeated-measures analysis (RM-ANOVA or Friedman test) will be used to examine time-based trends across the baseline, control phase, intervention phase, and post-intervention point. We will also analyze feasibility metrics, including completion rates, survey adherence, and treatment attendance.

Eligibility Criteria

Age Range: 20 years to 51 years

Inclusion Criteria: * Female Western University of Health Sciences students, faculty, or staff who experience dysmenorrhea symptoms. Exclusion Criteria: * 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.

Interventions

PROCEDURE

Osteopathic Manipulative Treatment (OMT)

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Conditions

Dysmenorrhea

Locations

Western University of Health Sciences

Pomona, California 91766-1854

United States