The Impact of Osteopathic Manipulative Treatment on Pelvic Floor Dysfunction, Activity, and Gait in Female Runners

NCT07812285 — Not applicable, Recruiting, 10 participants, Elizabeth Perrero

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Registry	NCT07812285
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	10 (Estimated)
Sponsor	Elizabeth Perrero (Other)
Conditions	Pelvic Floor Disfunction
Interventions	Osteopathic Manipulative Treatment (OMT) (Procedure)
Dates	start 2026-09-05, primary completion 2026-11-28 (estimated), completion 2026-11-28 (estimated), first posted 2026-09-10, last updated 2026-09-23
Locations	1 site in United States

-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. Participants will also use wearable devices to track physical activity throughout the study.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

Osteopathic Manipulative Treatment (OMT) (Procedure): OMT will be provided to treat somatic dysfunction identified during the osteopathic structural examination.

+Outcome measures

Primary outcomes

Change in Pelvic Floor Dysfunction Symptoms [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 [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 [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.

+Eligibility

Sex: Female, ages: 18 Years to 35 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of Kentucky	Lexington, Kentucky	United States	Recruiting