Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology (TMJ and Pelvis)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Prolapse; Female; Endometriosis-related Pain
• Intervention / Treatment: Other: Visceral therapy; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Małgorzata E Wójcik, Dr; Phone Number: 51 +4895 727 91 00; Email: m.wojcik@awf-gorzow.edu.pl
• Study Contact Backup: Name: Anna M Paczkowska, Dr; Phone Number: 12 +4861 285 40 31

Study Locations

• Poland
  • Poznan, Poland, 61-871
    • Recruiting
    • Poznań University of Physical Education
    • Contact: Małgorzata M Wójcik, Dr; Phone Number: 32 +48(95) 72 79 100; Email: m.wojcik@awf-gorzow.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 subgroups with wisceral therapy; 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; 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 Comparator: 2 subgroups with placebo (without intervention); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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 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 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 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 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.	1 st week, 2nd week, 3rd week,4th week, 5 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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 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 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 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 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 point two: after visceral therapy and placebo, 5th week

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education
• Collaborators: University of Life Science in Poznan

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 29, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: women; temporomandibular joint; quaity of life; prolapse; female; endometriosis-related pain; visceral therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis; Prolapse
• Other Study ID Numbers: 305/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No