An interventional study of Osteopathic Manipulative Treatment (OMT) in Dysmenorrhea, sponsored by Western University of Health Sciences. Recruiting at 1 site in United States. Open to female participants aged 20 Years to 51 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Western University of Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Western University of Health Sciences is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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).
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.
Time frame: Baseline, at the end of Cycle 1 (each cycle is 28 days), and at the end of Cycle 2 (an additional 28 days).
Premenstrual Syndrome Scale (PMSS) Scores
The PMSS (Premenstrual Syndrome Symptom Scale) is a self-assessment questionnaire consisting of 40 items designed to evaluate the severity of physiological, psychological, and behavioral symptoms associated with Premenstrual Syndrome (PMS). It employs a 5-point Likert scale to score symptom severity, where "never" is 1, "rarely" 2, "sometimes" 3, "very often" 4, and "always" 5. The total score can range from a minimum of 40 points to a maximum of 220 points. A score of 80 points or higher indicates the presence of PMS, with higher scores reflecting greater symptom severity.
Time frame: 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
The WaLIDD score is a 4-item questionnaire designed to assess the severity of dysmenorrhea. It consists of the following components: 1. Number of Anatomical Pain Locations * "0" = no part of the body * "1" = pain in 1 site * "2" = pain in 2-3 sites * "3" = pain in 4 sites 2. Wong-Baker Pain Intensity Rating * "0" = does not hurt * "1" = hurts a little bit * "2" = hurts a little more or even more * "3" = hurts a lot or hurts worst 3. Number of Painful Days During the Menstrual Period * "0" = 0 days * "1" = 1-2 days * "2" = 3-4 days * "3" = 5+ days 4. Frequency of Pain that Prevents Activities * "0" = none * "1" = almost none * "2" = almost always * "3" = always Each item scores between 0 and 3, resulting in a total score ranging from 0 to 12. A higher score indicates a greater degree of dysmenorrhea. Specifically, a score of 0 suggests no dysmenorrhea, 1-4 indicates mild, 5-7 indicates moderate, and 7-12 indicates severe dysmenorrhea.
Time frame: 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)
The Quantitative Analgesic Questionnaire is a tool that was initially designed to document and quantify patient-reported medication use in settings of chronic pain. The QAQ was found to be a valuable tool in quantifying medication regimen and tracking changes over time. For this study, the QAQ was adapted to include only Section A, with wording modified to reflect analgesic use for dysmenorrhea. Sections B and C were excluded because they assess medications not typically used in the management of dysmenorrhea. Participants will report the type, dose, frequency, and duration of analgesic medications taken. For frequency quantification, they will be asked how many days prior to and during their period they used medication or non-medication methods, on a scale of 1 to 10 days, with higher values indicating longer use of methods to tolerate symptoms prior to periods. This will allow for the quantification of medication use and the evaluation of differences in analgesic consumption.
Time frame: Baseline, at the end of Cycle 1 (each cycle is 28 days), and at the end of Cycle 2 (an additional 28 days).
Plan to share: Yes — All components of this study will be made available to other researchers if desired. Please reach out to the PI with requests.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Western University of Health Sciences