- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07812285
The Impact of Osteopathic Manipulative Treatment on Pelvic Floor Dysfunction, Activity, and Gait in Female Runners
September 3, 2026 updated by: Elizabeth Perrero
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elizabeth Perrero
- Phone Number: 8593231100
- Email: elizabeth.perrero@uky.edu
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- Recruiting
- University of Kentucky
-
Contact:
- Elizabeth Perrero
- Phone Number: 8593231100
- Email: elizabeth.perrero@uky.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Males
- Run less than 15 miles per week
- Non-English speaking
- History of hip surgery
- Currently breastfeeding or pregnant
- Perimenopausal or menopausal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
OMT will be provided to treat somatic dysfunction identified during the osteopathic structural examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline to End of Study (6-8 Weeks)
|
|
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.
|
Baseline to End of Study (6-8 Weeks)
|
|
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.
|
Baseline to End of Study (6-8 Weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 5, 2026
Primary Completion (Estimated)
November 28, 2026
Study Completion (Estimated)
November 28, 2026
Study Registration Dates
First Submitted
August 31, 2026
First Submitted That Met QC Criteria
September 3, 2026
First Posted (Actual)
September 10, 2026
Study Record Updates
Last Update Posted (Actual)
September 10, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111754
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.