Impact of OMT on the Symptoms of Dysmenorrhea
ConditionDysmenorrhea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-51
SponsorWestern University of Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female Western University of Health Sciences students, faculty, or staff who experience dysmenorrhea symptoms.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Osteopathic Manipulative Treatment (OMT)
Procedure/SurgeryManual 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).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Control time period vs. OMT Intervention periodExperimental treatment 1 intervention
Trial outcomes
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.
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).Secondary outcomes
1
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).2
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).3
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).Sponsors and contacts
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Source ClinicalTrials.gov