Pelvic Floor DisfunctionNCT07812285
The Impact of Osteopathic Manipulative Treatment on Pelvic Floor Dysfunction, Activity, and Gait in Female Runners
A study testing Osteopathic Manipulative Treatment (OMT) in people with Pelvic Floor Disfunction, run by Elizabeth Perrero at 1 site in United States.
Trial summary
This study will examine whether osteopathic manipulative treatment (OMT) affects pelvic floor symptoms, physical activity, and running gait in female runners. Participants will complete six study sessions over 6 to 8 weeks that include questionnaires, gait assessments, and OMT. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disfunction
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2026to 28 Nov 2026
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females assigned female at birth
- Run at least 15 miles per week
- English speaking
- No previous history of hip surgery
- Not currently breastfeeding or pregnant
- Not perimenopausal or menopausal
Who cannot join
- Males
- Run less than 15 miles per week
- Non-English speaking
- History of hip surgery
- Currently breastfeeding or pregnant
- Perimenopausal or menopausal
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
University of Kentucky
Lexington, Kentucky, 40506
Elizabeth Perrero, 8593231100, elizabeth.perrero@uky.edu
About this study
This study will examine whether osteopathic manipulative treatment (OMT) affects pelvic floor symptoms, physical activity, and running gait in female runners. Participants will complete six study sessions over 6 to 8 weeks that include questionnaires, gait assessments, and OMT. Participants will also use wearable devices to track physical activity throughout the study.
- Conditions
- Pelvic Floor Disfunction
- Being tested
- Osteopathic Manipulative Treatment (OMT)
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
OMT will be provided to treat somatic dysfunction identified during the osteopathic structural examination.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Experimental | Participants will receive OMT to address somatic dysfunction identified during the osteopathic structural examination. All participants will receive the intervention over six treatment sessions during six to eight weeks. Receives: Procedure: Osteopathic Manipulative Treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic Floor Dysfunction Symptoms
Pelvic floor symptoms will be assessed using the Female Genitourinary Pain Index (Modified NIH Chronic Prostatitis Symptom Index for Women).
Measured: Baseline to End of Study (6-8 Weeks)
Total Training Load
Total training load will be assessed using Training Stress Score from the provided wearable device. Training Stress Score is a numeric value combine workout duration and intensity, with higher scores indicating greater training load and lower score indicating less training load.
Measured: Baseline to End of Study (6-8 Weeks)
Running Volume
Running volume will be assessed using data from the provided wearable device. The unit of measure for this outcome is miles.
Measured: Baseline to End of Study (6-8 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start5 Sep 2026
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisfunctionStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth Perrero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Perrero, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812285
- Sponsor's protocol ID
- 111754
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Osteopathic Manipulative Treatment on Pelvic Floor Dysfunction, Activity, and Gait in Female Runners
- ClinicalTrials.gov ID
- NCT07812285
- Acronym / sponsor ID
- 111754
- Conditions
- Pelvic Floor Disfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Elizabeth PerreroUniversity, hospital or other
- Study start
- 5 Sep 2026 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 10 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 study will examine whether osteopathic manipulative treatment (OMT) affects pelvic floor symptoms, physical activity, and running gait in female runners. Participants will complete six study sessions over 6 to 8 weeks that include questionnaires, gait assessments, and OMT. Participants will also use wearable devices to track physical activity throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT) | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT)Participants will receive OMT to address somatic dysfunction identified during the osteopathic structural examination. All participants will receive the intervention over six treatment sessions during six to eight weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy females assigned female at birth
- Run at least 15 miles per week
- English speaking
- No previous history of hip surgery
- Not currently breastfeeding or pregnant
Key exclusion criteria (6 listed)
- Males
- Run less than 15 miles per week
- Non-English speaking
- History of hip surgery
- Currently breastfeeding or pregnant
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)OMT will be provided to treat somatic dysfunction identified during the osteopathic structural examination. | Procedure or surgery | Osteopathic Manipulative Treatment (OMT) |
Primary outcome
Change in Pelvic Floor Dysfunction Symptoms
Time frame: Baseline to End of Study (6-8 Weeks)
Pelvic floor symptoms will be assessed using the Female Genitourinary Pain Index (Modified NIH Chronic Prostatitis Symptom Index for Women).
Total Training Load
Time frame: Baseline to End of Study (6-8 Weeks)
Total training load will be assessed using Training Stress Score from the provided wearable device. Training Stress Score is a numeric value combine workout duration and intensity, with higher scores indicating greater training load and lower score indicating less training load.
Running Volume
Time frame: Baseline to End of Study (6-8 Weeks)
Running volume will be assessed using data from the provided wearable device. The unit of measure for this outcome is miles.
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 23 Sep 2026.
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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.
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 Pelvic Floor Disfunction, run by Elizabeth Perrero 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 6 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 23 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 Elizabeth Perrero (8593231100, elizabeth.perrero@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pelvic Floor Dysfunction Symptoms (time frame: Baseline to End of Study (6-8 Weeks)). The study lists 3 primary outcomes in all. 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 23 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.