Does Self-Soft Tissue Mobilization of Obturator Internus Reduce Pelvic Floor or Hip Dysfunction

NCT ID: NCT07114068

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-28
• Study Completion Date: 2024-05-27

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.

Conditions

Pelvic Floor Dysfunction; Hip Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Internal Mobilization Group

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

Group Type: ACTIVE_COMPARATOR

Self mobilization of Obturator Internus Muscle using wand

Intervention Type: OTHER

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 Group

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

Group Type: ACTIVE_COMPARATOR

Self mobilization of Obturator Internus Muscle using wand

Intervention Type: OTHER

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.

Interventions

Self mobilization of Obturator Internus Muscle using wand

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

George Fox University

OTHER

Sponsor Role: lead

Responsible Party

Tess Treinen Swake

Physical Therapist, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

George Fox University Medical Sciences Building

Newberg, Oregon, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 36528838 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 36125508 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26721470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21613956 (View on PubMed)

Other Identifiers

2231085

Identifier Type: -

Identifier Source: org_study_id