[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658329":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":23,"armGroups":31,"interventions":38,"overallOfficials":44,"centralContacts":48,"locations":53,"responsibleParty":67,"collaborators":23,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":23,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":55,"whyStopped":23,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Western University of Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"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).",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"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.\n\nThe 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.",{"measure":18,"description":19,"timeFrame":12},"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:\n\n1. Number of Anatomical Pain Locations\n\n   * \"0\" = no part of the body\n   * \"1\" = pain in 1 site\n   * \"2\" = pain in 2-3 sites\n   * \"3\" = pain in 4 sites\n2. Wong-Baker Pain Intensity Rating\n\n   * \"0\" = does not hurt\n   * \"1\" = hurts a little bit\n   * \"2\" = hurts a little more or even more\n   * \"3\" = hurts a lot or hurts worst\n3. Number of Painful Days During the Menstrual Period\n\n   * \"0\" = 0 days\n   * \"1\" = 1-2 days\n   * \"2\" = 3-4 days\n   * \"3\" = 5+ days\n4. Frequency of Pain that Prevents Activities\n\n   * \"0\" = none\n   * \"1\" = almost none\n   * \"2\" = almost always\n   * \"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.",{"measure":21,"description":22,"timeFrame":12},"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.\n\nFor 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.\n\nParticipants 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.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE","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.\n\nThe 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.\n\nFollowing 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.\n\nFollowing 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.\n\nThe 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).\n\nData 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.\n\nDescriptive 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.",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"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.",[37],"Procedure: Osteopathic Manipulative Treatment (OMT)",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":23},"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).",[33],[45],{"name":46,"affiliation":5,"role":47},"David Redding, DO","PRINCIPAL_INVESTIGATOR",[49],{"name":46,"role":50,"phone":51,"phoneExt":23,"email":52},"CONTACT","909-469-5281","dredding@westernu.edu",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":23},"RECRUITING","Pomona","California","91766-1854","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-117.75228,34.05529,{"lat":65,"lon":64},{"type":47,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"David Redding","Associate Professor of NMM\u002FOMM and Family Medicine","100658329","impact-of-omt-on-the-symptoms-of-dysmenorrhea-100658329",false,"NCT07849140","Impact of OMT on the Symptoms of Dysmenorrhea","Assessing the Impact of Osteopathic Manipulative Treatment on Dysmenorrhea","Inclusion Criteria:\n\n* Female Western University of Health Sciences students, faculty, or staff who experience dysmenorrhea symptoms.\n\nExclusion Criteria:\n\n* Individuals who are pregnant or breastfeeding.\n* Individuals under the age of 20 and over the age of 51.\n* Individuals with a history of endometriosis or PCOS.\n* Individuals with a history of thyroid conditions.\n* Individuals who change or plan ot change birth control during the course of the study.\n* Individuals receiving outside OMT or physical therapy treatment.","FEMALE","20 Years","51 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[25],"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.",[87],"Dysmenorrhea",[89,87,90,91],"OMT","Osteopathic Manipulative Treatment","Osteopathic Manipulative Medicine","2026-09-23",{"date":94,"type":95},"2026-09-30","ACTUAL",{"date":97,"type":95},"2026-04-30",{"date":99,"type":82},"2027-12-31",{"name":5,"class":6},1]