Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

Endometriosis-related Pain Clinical Trial

— TMJ and Pelvis  

Official title:

Functional Relationships Between the Temporomandibular Joint and the Pelvis in Women With Gynecological Diseases of Genital Prolapse and Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978414
• Other study ID #: 305/23
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: November 2023
• Source: Poznan University of Physical Education
• Contact: Malgorzata E Wójcik, Dr
• Phone: +4895 727 91 00
• Email: m.wojcik[@]awf-gorzow.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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. The SF-36 questionnaire, FSFI scale, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis-related Pain
• Prolapse
• Prolapse; Female

Intervention

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
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.

Locations

Country	Name	City	State
Poland	Poznan University of Physical Education	Poznan

Sponsors (3)

Lead Sponsor	Collaborator
Poznan University of Physical Education	Hospital in Sroda Wielkopolska, University of Life Science in Poznan

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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,
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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