DysmenorrheaNCT07849140
Impact of OMT on the Symptoms of Dysmenorrhea
A study testing Osteopathic Manipulative Treatment (OMT) in people with Dysmenorrhea, run by Western University of Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 51 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female Western University of Health Sciences students, faculty, or staff who experience dysmenorrhea symptoms.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Western University of Health Sciences
Pomona, California, 91766-1854
About this study
Official title: Assessing the Impact of Osteopathic Manipulative Treatment on Dysmenorrhea
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.
Read the 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.
- Conditions
- Dysmenorrhea
- Being tested
- Osteopathic Manipulative Treatment (OMT)
- Keywords
- OMT, Dysmenorrhea, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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:
- 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
- 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
- Number of Painful Days During the Menstrual Period
- "0" = 0 days
- "1" = 1-2 days
- "2" = 3-4 days
- "3" = 5+ days
- 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.
Measured: 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.
Measured: Baseline, at the end of Cycle 1 (each cycle is 28 days), and at the end of Cycle 2 (an additional 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Redding, Western University of Health Sciences
- Investigators
- David Redding, DO, Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849140
- Sponsor's protocol ID
- P26IRB013
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All components of this study will be made available to other researchers if desired. Please reach out to the PI with requests.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Osteopathic Manipulative Treatment on Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07849140
- Acronym / sponsor ID
- P26IRB013
- Conditions
- Dysmenorrhea
- Keywords
- OMT, Dysmenorrhea, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control time period vs. OMT Intervention period | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT)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. |
Who may qualify
- Ages
- 20 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female Western University of Health Sciences students, faculty, or staff who experience dysmenorrhea symptoms.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Control time period vs. OMT Intervention period |
Primary outcome
Menstrual Pain Numeric Scale Rating (NRS)
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).
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.
3 secondary outcomes
Premenstrual Syndrome Scale (PMSS) Scores
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
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)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. All components of this study will be made available to other researchers if desired. Please reach out to the PI with requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Redding, DO principal investigator
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment (OMT) in people with Dysmenorrhea, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Redding, DO (909-469-5281, dredding@westernu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Pain Numeric Scale Rating (NRS) (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.