NCT07812285 · Elizabeth Perrero
The Impact of Osteopathic Manipulative Treatment on Pelvic Floor Dysfunction, Activity, and Gait in Female Runners
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Osteopathic Manipulative Treatment (OMT)
OMT will be provided to treat somatic dysfunction identified during the osteopathic structural examination.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Run less than 15 miles per week
- Non-English speaking
- History of hip surgery
- Currently breastfeeding or pregnant
- Perimenopausal or menopausal
Where
- Lexington, Kentucky
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations