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NCT Number: NCT05978414

Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

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.

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Key information

Conditions

Prolapse; Female Endometriosis-related Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Physical Education

Poznan, 61-871, Poland

Location status: Recruiting

Location contact

Małgorzata M Wójcik, Dr

CONTACT

[email protected]

+48(95) 72 79 100 ext. 32

About this study

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.

  • 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.

  • Assessment of mobility in the temporomandibular joints in the sagittal plane CromWell digital caliper, and diagnosis using standardized protocols.
  • Postural assessment on the Posturomed Technomex platform and Podoscope Sensor Medica.
  • 6.Manual visceral treatments The treatments will be performed after the patient is qualified by the obstetrician-gynecologist specialist.
  • After performing techniques and placebo in both groups, filling out questionnaires again, measuring on the platform, pattern posture..
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visceral therapy

Other

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

Other

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 outcomes

  1. NRS

    Time frame: Time point one: before starting visceral therapy and placebo, 1 st week

    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.

  2. platforms

    Time frame: Time point one: before starting visceral therapy and placebo,1 st week

    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.

  3. postural pattern by Halla-Wernhama-Littlejohna

    Time frame: Time point one: before starting visceral therapy and placeb1 st weeko,

    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.

  4. pelvic type assessment

    Time frame: Time point one: before starting visceral therapy and placebo,1 st week

    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.

  5. CromWell (measurement of oral dilation)

    Time frame: Time point one: before starting visceral therapy and placebo,1 st week

    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.

  6. standarised questonarie by Kulesa-Morawiecka et al.

    Time frame: Time point one: before starting visceral therapy and placebo,1 st week

    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.

  7. 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.

    Time frame: Time point one: before starting visceral therapy and placebo,1 st week

    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.

  8. Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.

    Time frame: Time point one: before starting visceral therapy and placebo,1 st week

    Each patient will complete a questionnaire.

  9. visceral techniques and placebo

    Time frame: 1 st week, 2nd week, 3rd week,4th week, 5 week

    The intervention group will have visceral therapy performed. The group without intervention will only have their hands held on the pelvis.

Secondary outcomes

  1. NRS

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    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.

  2. platforms

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    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.

  3. postural pattern by Halla-Wernhama-Littlejohna

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    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.

  4. pelvic type assessment

    Time frame: Time point two: after visceral therapy and placebo,5 th week

    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.

  5. CromWell (measurement of oral dilation)

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    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.

  6. standarised questonarie by Kulesa-Morawiecka et al.

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    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.

  7. 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.

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    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.

  8. Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    After 5 weeks, each patient will complete a sexual satisfaction questionnaire

  9. World Health Organization Quality of Life BREF (WHOQOL-BREF)

    Time frame: Time point two: after visceral therapy and placebo, 5th week

    After 5 weeks, each patient will complete a sexual satisfaction questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Anna M Paczkowska, Dr

CONTACT

+4861 285 40 31 ext. 12

Małgorzata E Wójcik, Dr

CONTACT

[email protected]

+4895 727 91 00 ext. 51

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Collaborators

  • University of Life Science in Poznan

Registry information

Official study title

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

Acronym: TMJ and Pelvis

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2023
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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