NCT07114068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 3, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

self soft tissue mobilizationpelvic floor dysfunctionactive females

Outcome Measures

Primary Outcomes (2)

  • International Consensus on Incontinence Questionnaire (ICIQ-FLUTS Long Form)

    A questionnaire that evaluates female lower urinary tract symptoms and quality of life in clinical practice and research. This questionnaire has been found to be valid, reliable, and responsive.

    At enrollment and completion (2 weeks later)

  • Patient Reported Outcome Measure Information System (PROMIS): Anxiety & Depression

    measures are scored on the T-score metric. Higher scores mean more of the attribute being measured (e.g., more Fatigue, more Physical Function). Thus, a score of 60 is one standard deviation above the average reference population. PROMIS measures are rigorously developed and validated self-report tools spanning 300+ measures across physical, mental, and social health (https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis). As a Computer Adaptive Test (CAT), each measure asks 4-10 questions (average 5-6) drawn from the total item bank.

    Initial enrollment and at completion (2 weeks later)

Study Arms (2)

Internal Mobilization Group

ACTIVE COMPARATOR

This group performs self mobilization of the Obturator Internus muscle internally.

Other: Self mobilization of Obturator Internus Muscle using wand

External Mobilization Group

ACTIVE COMPARATOR

This group performs self mobilization of the Obturator Internus muscle externally.

Other: Self mobilization of Obturator Internus Muscle using wand

Interventions

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.

External Mobilization GroupInternal Mobilization Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 18-45 years
  • Female gender
  • Current pelvic floor dysfunction (relaxing or nonrelaxing) or current hip pain
  • Participants must be physically active as defined by the World Health Organization as performing 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week.

You may not qualify if:

  • Pregnancy
  • Gynecological or Obstetric Surgery within 6 months
  • Active infection (including Sexually Transmitted Infection, Pelvic, Yeast)
  • Cancer
  • Inflammatory Disease
  • Connective Tissue Disease
  • Or have been instructed by a Healthcare provider to not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Fox University Medical Sciences Building

Newberg, Oregon, 97132, United States

Location

Related Publications (8)

  • Muro S, Nimura A, Ibara T, Chikazawa K, Nakazawa M, Akita K. Anatomical basis for contribution of hip joint motion by the obturator internus to defaecation/urinary functions by the levator ani via the obturator fascia. J Anat. 2023 Apr;242(4):657-665. doi: 10.1111/joa.13810. Epub 2022 Dec 18.

    PMID: 36528838BACKGROUND
  • Morris VC, Murray MP, Delancey JO, Ashton-Miller JA. A comparison of the effect of age on levator ani and obturator internus muscle cross-sectional areas and volumes in nulliparous women. Neurourol Urodyn. 2012 Apr;31(4):481-6. doi: 10.1002/nau.21208. Epub 2012 Feb 29.

    PMID: 22378544BACKGROUND
  • Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle TM, Lowder JL. A pilot trial of movement-based pelvic floor physical therapy to address pelvic floor myofascial pain and lower urinary tract symptoms. Int Urogynecol J. 2023 Jun;34(6):1261-1270. doi: 10.1007/s00192-022-05353-9. Epub 2022 Sep 20.

    PMID: 36125508BACKGROUND
  • Lewis GK, Chen AH, Craver EC, Crook JE, Carrubba AR. Trigger point injections followed by immediate myofascial release in the treatment of pelvic floor tension myalgia. Arch Gynecol Obstet. 2023 Apr;307(4):1027-1035. doi: 10.1007/s00404-022-06880-y. Epub 2022 Dec 14.

    PMID: 36513896BACKGROUND
  • Crowle, A., and C. Harley. "Exploration of the Efficacy of Myofascial Release and Trigger Point Therapy for Women with Pelvic Organ Prolapse." Physiotherapy 107 (2020): e104-e104. Web.

    BACKGROUND
  • Cage, Stephen A., and Brandon J. Warner. "Idiopathic Obturator Internus Strain in a Collegiate Tennis Player: A Case Report." The Journal of Sports Medicine and Allied Health Sciences 3.2 (2017): n. pag. Web.

    BACKGROUND
  • Anderson RU, Wise D, Sawyer T, Nathanson BH, Nevin Smith J. Equal Improvement in Men and Women in the Treatment of Urologic Chronic Pelvic Pain Syndrome Using a Multi-modal Protocol with an Internal Myofascial Trigger Point Wand. Appl Psychophysiol Biofeedback. 2016 Jun;41(2):215-24. doi: 10.1007/s10484-015-9325-6.

    PMID: 26721470BACKGROUND
  • Anderson R, Wise D, Sawyer T, Nathanson BH. Safety and effectiveness of an internal pelvic myofascial trigger point wand for urologic chronic pelvic pain syndrome. Clin J Pain. 2011 Nov-Dec;27(9):764-8. doi: 10.1097/AJP.0b013e31821dbd76.

    PMID: 21613956BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, Assistant Professor

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 11, 2025

Study Start

January 28, 2024

Primary Completion

May 27, 2024

Study Completion

May 27, 2024

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations