Prolapse; FemaleTMJ and PelvisNCT05978414
Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
A study testing Visceral therapy in people with Prolapse; Female and Endometriosis-related Pain, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment. 5. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Prolapse; Female, Endometriosis-related Pain
- What is being tested?
- Visceral therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 14 Nov 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written consent to participate in the study.
- Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis.
Who cannot join
- No written consent to participate in the study.
- Cancer.
- Injury to the temporomandibular joint and pelvis.
- Fibromyalgia.
- Rheumatic diseases.
- At each stage of the experiment if the patient decides that she does not want to participate she is excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna M Paczkowska, Dr contact
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Physical Education
Poznan, 61-871
Małgorzata M Wójcik, Dr, +48(95) 72 79 100 ext. 32, m.wojcik@awf-gorzow.edu.pl
About this study
Official title: Functional Relationships Between the Temporomandibular Joint and the Pelvis in Women With Gynecological Diseases of Genital Prolapse and Endometriosis
1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment.
- Performance of visceral therapy in the group with intervention, in the group without intervention placebo. Duration 5 weeks, treatment 1x per week at the same time of day and given day e.g. Mondays only.
- Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.
Read the detailed description
Methods
After taking a detailed history, patients will be asked to:
- Completing: the SF-36 quality of life assessment questionnaire and Female Sexual Function Index assessment, and marking on a numerical scale their pain sensations for the temporomandibular joint and for the pelvis, World Health Organization Quality of Life BREF (WHOQOL-BREF). The SF-36 questionnaire, FSFI scale, World Health Organization Quality of Life BREF (WHOQOL-BREF) and numerical scale (assessing pain sensations for the temporomandibular joint and pelvic joint), will also be subjected to completion/checking after the completion of manual visceral treatments in groups with physiotherapy intervention for both conditions.
- Type of postural pattern according to Hall-Wernham-Littlejohn: type I - normal, type II - anterior pelvic tilt, type III - posterior pelvic tilt.
3 Pelvic type assessment: normal, high, low; pelvic type will be assessed in each patient and in groups with physiotherapeutic intervention for both conditions before and after manual visceral treatments.
- Assessment of mobility in the temporomandibular joints in the sagittal plane CromWell digital caliper, and diagnosis using standardized protocols.
- Postural assessment on the Posturomed Technomex platform and Podoscope Sensor Medica.
- 6.Manual visceral treatments The treatments will be performed after the patient is qualified by the obstetrician-gynecologist specialist.
- After performing techniques and placebo in both groups, filling out questionnaires again, measuring on the platform, pattern posture..
- Statistical analysis: upon completion of the study, the collected quantitative and qualitative data will be subjected to statistical analysis. The choice of statistical tools will depend on the obtained probability distribution.
- Conditions
- Prolapse; Female, Endometriosis-related Pain
- Being tested
- Visceral therapy, Placebo
- Keywords
- quaity of life, women, prolapse; female, endometriosis-related pain, visceral therapy, temporomandibular joint
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral therapyOther
Visceral therapy will be performed manually by a physiotherapist, a detailed description of the techniques is above. Therapy will be in 2 subgroups with prolapse of the usual genitals and endometriosis.
PlaceboOther
Placebo will be in 2 subgroups that will not have visceral therapy. The placebo will consist of the physiotherapist holding hands on the patient's pelvis.
| Study group | Role | What they receive |
|---|---|---|
| 2 subgroups with wisceral therapy | Experimental | A group of women with endometriosis and reproductive organ prolapse will be randomly assigned to the intervention will have visceral therapy performed, and the group without the intervention will have a placebo. Receives: Other: Visceral therapy |
| 2 subgroups with placebo (without intervention) | Placebo comparator | The group of women with endometriosis and reproduvtive organ prolapse without the intervention will have a placebo only hands held on the pelvis by a physiotherapist. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Each patient will mark on the NRS scale the sensation of pain before the tests. Scale of 1-10, the higher the value the greater the pain experience.
Measured: Time point one: before starting visceral therapy and placebo, 1 st week
platforms
Each patient will have a postural stability assessment prior to testing.No platform manufacturer provides standards. The platform is equipped with sensors - it collects the force of the feet and gives how the center of gravity is located, that is, the front-back, side-to-side tilts are given.
Measured: Time point one: before starting visceral therapy and placebo,1 st week
postural pattern by Halla-Wernhama-Littlejohna
Before the test, each patient will have a postural pattern assessment. Evaluating the pattern of type 1 anterior tilt of the body, type 2 normal, type 3 posterior tilt.
Measured: Time point one: before starting visceral therapy and placeb1 st weeko,
pelvic type assessment
Before the test, each patient will have a pelvic type assessment. High-assimilated type: hip plates above the L5 segment: overloaded type: hip plates below the L4 segment; normal type: hip plates at the level of the L4-L5 segment.
Measured: Time point one: before starting visceral therapy and placebo,1 st week
CromWell (measurement of oral dilation)
Before the test, each patient will have their mouth opening measured with an electronic caliper.There are no standards given, it is a measurement of the dilation of the mouth.
Measured: Time point one: before starting visceral therapy and placebo,1 st week
standarised questonarie by Kulesa-Morawiecka et al.
Each patient will complete a questionnaire on the evaluation of the temporomandibular joint. Scale of 0-10 points, 0 - means no strength of head and neck muscles, 10 - means strong tension of head and neck muscles.
Measured: Time point one: before starting visceral therapy and placebo,1 st week
According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.
Each patient will complete a questionnaire on the evaluation of quality of life.Assessment: physical functioning, limitations due to physical health, pain perception, general sense of health, vitality, social functioning, emotional functioning and mental health.
Measured: Time point one: before starting visceral therapy and placebo,1 st week
Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
Each patient will complete a questionnaire.
Measured: Time point one: before starting visceral therapy and placebo,1 st week
visceral techniques and placebo
The intervention group will have visceral therapy performed. The group without intervention will only have their hands held on the pelvis.
Measured: 1 st week, 2nd week, 3rd week,4th week, 5 week
Masseter Muscles Tension
The device was developed by the authors (PAT 2568 W.132167; patent W.132167). Its construction consists of two parallel beams between which strain gauges are placed to record their deformation under applied compressive force. The signal from the strain gauges was transmitted to a force meter, which displayed the result in mass units (kilograms). The recorded result was entered into an Excel spreadsheet. Measurements were performed under both eyes-open and eyes-closed conditions. Each measurement lasted 30 seconds. A 5-minute rest interval was applied between the eyes-open and eyes-closed measurements
Measured: 2023-2025
Secondary outcomes (9)
NRS
After 5 weeks, each patient will mark on the pain sensation scale. Scale of 1-10, the higher the value the greater the pain experience.
Measured: Time point two: after visceral therapy and placebo, 5th week
platforms
After 5 weeks, each patient will have a postural stability assessment. No platform manufacturer provides standards. The platform is equipped with sensors - it collects the force of the feet and gives how the center of gravity is located, that is, the front-back, side-to-side tilts are given.
Measured: Time point two: after visceral therapy and placebo, 5th week
postural pattern by Halla-Wernhama-Littlejohna
After 5 weeks, each patient will have a posture pattern assessment. Evaluating the pattern of type 1 anterior tilt of the body, type 2 normal, type 3 posterior tilt.
Measured: Time point two: after visceral therapy and placebo, 5th week
pelvic type assessment
After 5 weeks, each patient will have a pelvic type assessment.High-assimilated type: hip plates above the L5 segment: overloaded type: hip plates below the L4 segment; normal type: hip plates at the level of the L4-L5 segment.
Measured: Time point two: after visceral therapy and placebo,5 th week
CromWell (measurement of oral dilation)
After 5 weeks, each patient will have an evaluation of oral dilation with an electronic caliper.There are no standards given, it is a measurement of the dilation of the mouth.
Measured: Time point two: after visceral therapy and placebo, 5th week
standarised questonarie by Kulesa-Morawiecka et al.
After 5 weeks, each patient will complete a temporomandibular joint evaluation questionnaire.Scale of 0-10 points, 0 - means no strength of head and neck muscles, 10 - means strong tension of head and neck muscles.
Measured: Time point two: after visceral therapy and placebo, 5th week
According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.
After 5 weeks, each patient will complete a quality of life questionnaire. Assessment: physical functioning, limitations due to physical health, pain perception, general sense of health, vitality, social functioning, emotional functioning and mental health.
Measured: Time point two: after visceral therapy and placebo, 5th week
Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
After 5 weeks, each patient will complete a sexual satisfaction questionnaire
Measured: Time point two: after visceral therapy and placebo, 5th week
World Health Organization Quality of Life BREF (WHOQOL-BREF)
After 5 weeks, each patient will complete a sexual satisfaction questionnaire
Measured: Time point two: after visceral therapy and placebo, 5th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start14 Nov 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse; FemaleStudies 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
- Model description
- Description of the study group: The study will qualify women, aged from 18 to 60 years old admitted to the Sredz Heart Hospital in Sroda Wielkopolska, gynecology and obstetrics department. The planned study group is 200 women after surgical treatment (100 with prolapse of reproductive organs and 100 with a diagnosis of endometriosis). Both conditions are planned to be randomly divided into: a subgroup undergoing physiotherapy intervention and a subgroup without physiotherapy intervention. Women who do not consent to physiotherapeutic intervention will be included in the control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- University of Life Science in Poznan
- Responsible party
- Principal investigator, Małgorzata Wójcik, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978414
- Sponsor's protocol ID
- 305/23
- Acronym
- TMJ and Pelvis
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Relationships Between the Temporomandibular Joint and the Pelvis in Women With Gynecological Diseases of Genital Prolapse and Endometriosis
- ClinicalTrials.gov ID
- NCT05978414
- Acronym / sponsor ID
- TMJ and Pelvis / 305/23
- Conditions
- Prolapse; Female, Endometriosis-related Pain
- Keywords
- quaity of life, women, prolapse; female, endometriosis-related pain, visceral therapy, temporomandibular joint
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- University of Life Science in Poznan
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Aug 2023 (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.
1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment.
- Performance of visceral therapy in the group with intervention, in the group without intervention placebo. Duration 5 weeks, treatment 1x per week at the same time of day and given day e.g. Mondays only.
- Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.
Detailed description
Methods
After taking a detailed history, patients will be asked to:
- Completing: the SF-36 quality of life assessment questionnaire and Female Sexual Function Index assessment, and marking on a numerical scale their pain sensations for the temporomandibular joint and for the pelvis, World Health Organization Quality of Life BREF (WHOQOL-BREF). The SF-36 questionnaire, FSFI scale, World Health Organization Quality of Life BREF (WHOQOL-BREF) and numerical scale (assessing pain sensations for the temporomandibular joint and pelvic joint), will also be subjected to completion/checking after the completion of manual visceral treatments in groups with physiotherapy intervention for both conditions.
- Type of postural pattern according to Hall-Wernham-Littlejohn: type I - normal, type II - anterior pelvic tilt, type III - posterior pelvic tilt.
3 Pelvic type assessment: normal, high, low; pelvic type will be assessed in each patient and in groups with physiotherapeutic intervention for both conditions before and after manual visceral treatments.
- Assessment of mobility in the temporomandibular joints in the sagittal plane CromWell digital caliper, and diagnosis using standardized protocols.
- Postural assessment on the Posturomed Technomex platform and Podoscope Sensor Medica.
- 6.Manual visceral treatments The treatments will be performed after the patient is qualified by the obstetrician-gynecologist specialist.
- After performing techniques and placebo in both groups, filling out questionnaires again, measuring on the platform, pattern posture..
- Statistical analysis: upon completion of the study, the collected quantitative and qualitative data will be subjected to statistical analysis. The choice of statistical tools will depend on the obtained probability distribution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Description of the study group: The study will qualify women, aged from 18 to 60 years old admitted to the Sredz Heart Hospital in Sroda Wielkopolska, gynecology and obstetrics department. The planned study group is 200 women after surgical treatment (100 with prolapse of reproductive organs and 100 with a diagnosis of endometriosis). Both conditions are planned to be randomly divided into: a subgroup undergoing physiotherapy intervention and a subgroup without physiotherapy intervention. Women who do not consent to physiotherapeutic intervention will be included in the control group.
| Arm | Type | Receives |
|---|---|---|
| 2 subgroups with wisceral therapy | Experimental | Other: Visceral therapyA group of women with endometriosis and reproductive organ prolapse will be randomly assigned to the intervention will have visceral therapy performed, and the group without the intervention will have a placebo. |
| 2 subgroups with placebo (without intervention) | Placebo comparator | Other: PlaceboThe group of women with endometriosis and reproduvtive organ prolapse without the intervention will have a placebo only hands held on the pelvis by a physiotherapist. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Written consent to participate in the study.
- Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis.
Key exclusion criteria (6 listed)
- No written consent to participate in the study.
- Cancer.
- Injury to the temporomandibular joint and pelvis.
- Fibromyalgia.
- Rheumatic diseases.
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 |
|---|---|---|
| Visceral therapyVisceral therapy will be performed manually by a physiotherapist, a detailed description of the techniques is above. Therapy will be in 2 subgroups with prolapse of the usual genitals and endometriosis. | Other | 2 subgroups with wisceral therapy |
| PlaceboPlacebo will be in 2 subgroups that will not have visceral therapy. The placebo will consist of the physiotherapist holding hands on the patient's pelvis. | Other | 2 subgroups with placebo (without intervention) |
Primary outcome
NRS
Time frame: Time point one: before starting visceral therapy and placebo, 1 st week
Each patient will mark on the NRS scale the sensation of pain before the tests. Scale of 1-10, the higher the value the greater the pain experience.
platforms
Time frame: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will have a postural stability assessment prior to testing.No platform manufacturer provides standards. The platform is equipped with sensors - it collects the force of the feet and gives how the center of gravity is located, that is, the front-back, side-to-side tilts are given.
postural pattern by Halla-Wernhama-Littlejohna
Time frame: Time point one: before starting visceral therapy and placeb1 st weeko,
Before the test, each patient will have a postural pattern assessment. Evaluating the pattern of type 1 anterior tilt of the body, type 2 normal, type 3 posterior tilt.
pelvic type assessment
Time frame: Time point one: before starting visceral therapy and placebo,1 st week
Before the test, each patient will have a pelvic type assessment. High-assimilated type: hip plates above the L5 segment: overloaded type: hip plates below the L4 segment; normal type: hip plates at the level of the L4-L5 segment.
CromWell (measurement of oral dilation)
Time frame: Time point one: before starting visceral therapy and placebo,1 st week
Before the test, each patient will have their mouth opening measured with an electronic caliper.There are no standards given, it is a measurement of the dilation of the mouth.
standarised questonarie by Kulesa-Morawiecka et al.
Time frame: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will complete a questionnaire on the evaluation of the temporomandibular joint. Scale of 0-10 points, 0 - means no strength of head and neck muscles, 10 - means strong tension of head and neck muscles.
According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.
Time frame: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will complete a questionnaire on the evaluation of quality of life.Assessment: physical functioning, limitations due to physical health, pain perception, general sense of health, vitality, social functioning, emotional functioning and mental health.
Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
Time frame: Time point one: before starting visceral therapy and placebo,1 st week
Each patient will complete a questionnaire.
visceral techniques and placebo
Time frame: 1 st week, 2nd week, 3rd week,4th week, 5 week
The intervention group will have visceral therapy performed. The group without intervention will only have their hands held on the pelvis.
Masseter Muscles Tension
Time frame: 2023-2025
The device was developed by the authors (PAT 2568 W.132167; patent W.132167). Its construction consists of two parallel beams between which strain gauges are placed to record their deformation under applied compressive force. The signal from the strain gauges was transmitted to a force meter, which displayed the result in mass units (kilograms). The recorded result was entered into an Excel spreadsheet. Measurements were performed under both eyes-open and eyes-closed conditions. Each measurement lasted 30 seconds. A 5-minute rest interval was applied between the eyes-open and eyes-closed measurements
9 secondary outcomes
NRS
Time frame: Time point two: after visceral therapy and placebo, 5th week
platforms
Time frame: Time point two: after visceral therapy and placebo, 5th week
postural pattern by Halla-Wernhama-Littlejohna
Time frame: Time point two: after visceral therapy and placebo, 5th week
pelvic type assessment
Time frame: Time point two: after visceral therapy and placebo,5 th week
CromWell (measurement of oral dilation)
Time frame: Time point two: after visceral therapy and placebo, 5th week
standarised questonarie by Kulesa-Morawiecka et al.
Time frame: Time point two: after visceral therapy and placebo, 5th week
According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.
Time frame: Time point two: after visceral therapy and placebo, 5th week
Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
Time frame: Time point two: after visceral therapy and placebo, 5th week
World Health Organization Quality of Life BREF (WHOQOL-BREF)
Time frame: Time point two: after visceral therapy and placebo, 5th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Anna M Paczkowska, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral therapy in people with Prolapse; Female and Endometriosis-related Pain, run by Poznan University of Physical Education at 1 site in Poland.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Małgorzata E Wójcik, Dr (+4895 727 91 00 ext. 51, m.wojcik@awf-gorzow.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Time point one: before starting visceral therapy and placebo, 1 st week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.