Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-28 @ 1:11 PM
Study NCT ID:
NCT07114068
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Self-Soft Tissue Mobilization of Obturator Internus Reduce Pelvic Floor or Hip Dysfunction
Sponsor:
George Fox University
Organization:
Study Overview
Official Title:
Does Self-Soft Tissue Mobilization of Obturator Internus Reduce Pelvic Floor or Hip Dysfunction
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Obturator Internus is a muscle deep within the pelvis. Fifty percent of the muscle belly can be palpated internally within the pelvic floor and 50% of the muscle externally in the pelvis. This muscle is unique in the sense that it is both a muscle of the pelvic floor as well as a muscle of the hip. There is limited research for addressing Obturator Internus muscle dysfunction in rehabilitation, but during specialty training in Pelvic Health Physical Therapy, manual techniques addressing Obturator Internus tension are indicated as a treatment to reduce dysfunction with soft tissue mobilization. The goal of this research is twofold. Firstly, to assess if self-soft tissue mobilization of the Obturator Internus muscle is beneficial for active females with pelvic floor relaxing or nonrelaxing dysfunction (PFD) or hip pain, and secondly if internal or external mobilization of the Obturator Internus muscle is more beneficial.
Detailed Description:
The objectives of this study are to assess if self-soft tissue mobilization of the Obturator Internus muscle with a pelvic wand reduces relaxing or nonrelaxing PDF or hip pain and if symptoms are reduced, which group experienced a greater improvement (internal or external Obturator Internus mobilization). Participants will be randomly assigned to the internal or external Obturator Internus mobilization groups. The internal mobilization group will access the Obturator Internus muscle via the vagina, which is common practice in Pelvic Health Physical Therapy. The external mobilization group will be accessing the Obturator Internus muscle with the same pelvic wand, but externally. Pelvic wands will be provided for each participant at no cost and will be used for only that participant. Prior to intervention with a pelvic wand, each participant will be provided education regarding the anatomy of the pelvic floor and hip and a protocol review of the intervention. There will be initial data collected prior to beginning self-soft tissue mobilization, data collected at a midpoint and following the intervention protocol. Data will be collected via a survey in REDCap (HIPAA-compliant), created specifically for this research, which includes demographics, injury history, history of PFD and/or hip pain, characteristics of physical activity and/or sport(s), knowledge of pelvic floor musculature, and questions regarding the correlation between PFD and performance. International Consensus on Incontinence Questionnaire (ICIQ-FLUTS Long Form) and Patient Reported Outcomes Measurement Information System (PROMIS) questions to address biopsychosocial concerns (specifically Anxiety \& Depression) are also included.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: