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

Primary Purpose

Prolapse; Female, Endometriosis-related Pain

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Visceral therapy
Placebo
Sponsored by
Poznan University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolapse; Female focused on measuring quaity of life, women, prolapse; female, endometriosis-related pain, visceral therapy, temporomandibular joint

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Written consent to participate in the study. Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis. Exclusion Criteria: 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.

Sites / Locations

  • Poznan University of Physical EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2 subgroups with wisceral therapy

2 subgroups with placebo (without intervention)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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

Full Information

First Posted
June 28, 2023
Last Updated
July 29, 2023
Sponsor
Poznan University of Physical Education
Collaborators
University of Life Science in Poznan, Hospital in Sroda Wielkopolska
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1. Study Identification

Unique Protocol Identification Number
NCT05978414
Brief Title
Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
Acronym
TMJ and Pelvis
Official Title
Functional Relationships Between the Temporomandibular Joint and the Pelvis in Women With Gynecological Diseases of Genital Prolapse and Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Physical Education
Collaborators
University of Life Science in Poznan, Hospital in Sroda Wielkopolska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse; Female, Endometriosis-related Pain
Keywords
quaity of life, women, prolapse; female, endometriosis-related pain, visceral therapy, temporomandibular joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Women will be randomly assigned to a test and control group according to their disease. The person performing the visceral tests and techniques will not know which group the woman belongs to. The evaluator of the results will not know whether they are the group with or without visceral techniques.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2 subgroups with wisceral therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
2 subgroups with placebo (without intervention)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Visceral therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
NRS
Description
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
Title
platforms
Description
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
Title
postural pattern by Halla-Wernhama-Littlejohna
Description
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,
Title
pelvic type assessment
Description
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
Title
CromWell (measurement of oral dilation)
Description
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
Title
standarised questonarie by Kulesa-Morawiecka et al.
Description
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
Title
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.
Description
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
Title
Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
Description
Each patient will complete a questionnaire.
Time Frame
Time point one: before starting visceral therapy and placebo,1 st week
Title
visceral techniques and placebo
Description
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
Secondary Outcome Measure Information:
Title
NRS
Description
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
Title
platforms
Description
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
Title
postural pattern by Halla-Wernhama-Littlejohna
Description
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
Title
pelvic type assessment
Description
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
Title
CromWell (measurement of oral dilation)
Description
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
Title
standarised questonarie by Kulesa-Morawiecka et al.
Description
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
Title
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.
Description
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
Title
Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.
Description
After 5 weeks, each patient will complete a sexual satisfaction questionnaire
Time Frame
Time point two: after visceral therapy and placebo, 5th week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study will include women because diseases like endometriosis and genital prolapse are diseases of women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written consent to participate in the study. Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Małgorzata E Wójcik, Dr
Phone
+4895 727 91 00
Ext
51
Email
m.wojcik@awf-gorzow.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Anna M Paczkowska, Dr
Phone
+4861 285 40 31
Ext
12
Facility Information:
Facility Name
Poznan University of Physical Education
City
Poznan
ZIP/Postal Code
61-871
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Małgorzata M Wójcik, Dr
Phone
+48(95) 72 79 100
Ext
32
Email
m.wojcik@awf-gorzow.edu.pl

12. IPD Sharing Statement

Learn more about this trial

Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

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