Clinical trial NCT05978414: Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
Official title: Functional Relationships Between the Temporomandibular Joint and the Pelvis in Women With Gynecological Diseases of Genital Prolapse and Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolapse; Female
Endometriosis-related Pain
Keywords: quaity of life
women
prolapse; female
endometriosis-related pain
visceral therapy
temporomandibular joint
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
Collaborators: name: University of Life Science in Poznan
First posted: 2023-08-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Detailed description: Methods

After taking a detailed history, patients will be asked to:

1. 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.
2. 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Written consent to participate in the study.
2. Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis.

Exclusion Criteria:

1. No written consent to participate in the study.
2. Cancer.
3. Injury to the temporomandibular joint and pelvis.
4. Fibromyalgia.
5. Rheumatic diseases.
6. At each stage of the experiment if the patient decides that she does not want to participate she is excluded.

Primary outcomes:
measure: NRS
timeFrame: Time point one: before starting visceral therapy and placebo, 1 st week
measure: platforms
timeFrame: Time point one: before starting visceral therapy and placebo,1 st week
measure: postural pattern by Halla-Wernhama-Littlejohna
timeFrame: Time point one: before starting visceral therapy and placeb1 st weeko,
measure: pelvic type assessment
timeFrame: Time point one: before starting visceral therapy and placebo,1 st week
measure: CromWell (measurement of oral dilation)
timeFrame: Time point one: before starting visceral therapy and placebo,1 st week
measure: standarised questonarie by Kulesa-Morawiecka et al.
timeFrame: Time point one: before starting visceral therapy and placebo,1 st week
measure: 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.
timeFrame: Time point one: before starting visceral therapy and placebo,1 st week
measure: Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
timeFrame: Time point one: before starting visceral therapy and placebo,1 st week
measure: visceral techniques and placebo
timeFrame: 1 st week, 2nd week, 3rd week,4th week, 5 week
Secondary outcomes:
measure: NRS
timeFrame: Time point two: after visceral therapy and placebo, 5th week
measure: platforms
timeFrame: Time point two: after visceral therapy and placebo, 5th week
measure: postural pattern by Halla-Wernhama-Littlejohna
timeFrame: Time point two: after visceral therapy and placebo, 5th week
measure: pelvic type assessment
timeFrame: Time point two: after visceral therapy and placebo,5 th week
measure: CromWell (measurement of oral dilation)
timeFrame: Time point two: after visceral therapy and placebo, 5th week
measure: standarised questonarie by Kulesa-Morawiecka et al.
timeFrame: Time point two: after visceral therapy and placebo, 5th week
measure: 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.
timeFrame: Time point two: after visceral therapy and placebo, 5th week
measure: Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
timeFrame: Time point two: after visceral therapy and placebo, 5th week
measure: World Health Organization Quality of Life BREF (WHOQOL-BREF)
timeFrame: Time point two: after visceral therapy and placebo, 5th week
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Physical Education
Study officials:
References: