Pelvic Floor DysfunctionNCT07114068
Does Self-Soft Tissue Mobilization of Obturator Internus Reduce Pelvic Floor or Hip Dysfunction
A study testing Self mobilization of Obturator Internus Muscle using wand in people with Pelvic Floor Dysfunction and Hip Pain, run by George Fox University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pelvic Floor Dysfunction, Hip Pain
- What is being tested?
- Self mobilization of Obturator Internus Muscle using wand
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2024to 27 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Fox University Medical Sciences Building
Newberg, Oregon, 97132
About this study
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.
Read the 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
- Being tested
- Self mobilization of Obturator Internus Muscle using wand
- Keywords
- self soft tissue mobilization, pelvic floor dysfunction, active females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self mobilization of Obturator Internus Muscle using wandOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Internal Mobilization Group | Active comparator | This group performs self mobilization of the Obturator Internus muscle internally. Receives: 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. Receives: Other: Self mobilization of Obturator Internus Muscle using wand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Initial enrollment and at completion (2 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start28 Jan 2024
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Fox University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tess Treinen Swake, George Fox University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114068
- Sponsor's protocol ID
- 2231085
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36528838Morris 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.
PubMed 22378544Meister 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.
PubMed 36125508Lewis 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.
PubMed 36513896Crowle, 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.
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.
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.
PubMed 26721470Anderson 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.
PubMed 21613956
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Self-Soft Tissue Mobilization of Obturator Internus Reduce Pelvic Floor or Hip Dysfunction
- ClinicalTrials.gov ID
- NCT07114068
- Acronym / sponsor ID
- 2231085
- Conditions
- Pelvic Floor Dysfunction, Hip Pain
- Keywords
- self soft tissue mobilization, pelvic floor dysfunction, active females
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- George Fox UniversityUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal Mobilization Group | Active comparator | Other: Self mobilization of Obturator Internus Muscle using wandThis group performs self mobilization of the Obturator Internus muscle internally. |
| External Mobilization Group | Active comparator | Other: Self mobilization of Obturator Internus Muscle using wandThis group performs self mobilization of the Obturator Internus muscle externally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnancy
- Gynecological or Obstetric Surgery within 6 months
- Active infection (including Sexually Transmitted Infection, Pelvic, Yeast)
- Cancer
- Inflammatory Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self mobilization of Obturator Internus Muscle using wandParticipants 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. | Other | External Mobilization Group, Internal Mobilization Group |
Primary outcome
International Consensus on Incontinence Questionnaire (ICIQ-FLUTS Long Form)
Time frame: At enrollment and completion (2 weeks later)
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.
Patient Reported Outcome Measure Information System (PROMIS): Anxiety & Depression
Time frame: Initial enrollment and at completion (2 weeks later)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 36528838Muro 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.
- Background: PubMed 22378544Morris 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.
- Background: PubMed 36125508Meister 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.
- Background: PubMed 36513896Lewis 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.
- BackgroundCrowle, 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.
- BackgroundCage, 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: PubMed 26721470Anderson 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.
- Background: PubMed 21613956Anderson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self mobilization of Obturator Internus Muscle using wand in people with Pelvic Floor Dysfunction and Hip Pain, run by George Fox University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consensus on Incontinence Questionnaire (ICIQ-FLUTS Long Form) (time frame: At enrollment and completion (2 weeks later)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07114068, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.