An interventional study of Visceral therapy and Placebo in Prolapse; Female and Endometriosis-related Pain, sponsored by Poznan University of Physical Education. Recruiting at 1 site in Poland. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Treatment
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. 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.
6. Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.
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.
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.
4. Assessment of mobility in the temporomandibular joints in the sagittal plane CromWell digital caliper, and diagnosis using standardized protocols.
5. Postural assessment on the Posturomed Technomex platform and Podoscope Sensor Medica.
6. 6.Manual visceral treatments The treatments will be performed after the patient is qualified by the obstetrician-gynecologist specialist.
7. After performing techniques and placebo in both groups, filling out questionnaires again, measuring on the platform, pattern posture..
8. 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.
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 65 interventional studies indexed under Prolapse.
Browse Prolapse studies →Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Visceral therapy
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.
Other: Placebo
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 2023-2025
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
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.
After 5 weeks, each patient will complete a sexual satisfaction questionnaire
Time frame: 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
Time frame: Time point two: after visceral therapy and placebo, 5th week
Started Nov 2023 (actual). Primary completion is estimated for Sep 2026, 34 months after the start.
Of 35 non-industry interventional studies with no phase under Prolapse, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 66. This study's planned 34 months is close to that.
Counting every sponsor, half of 37 studies reached it within 36 months; a quarter within 17 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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Poznan University of Physical Education