Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

NCT05978414 | Recruiting DMC

• 1 other identifier: 305/23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolapse; Female; Endometriosis-related Pain

Keywords

quaity of life; women; prolapse; female; endometriosis-related pain; visceral therapy; temporomandibular joint

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• NRS

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

• platforms

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

• postural pattern by Halla-Wernhama-Littlejohna

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

• pelvic type assessment

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

• CromWell (measurement of oral dilation)

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

Study Arms (2)

2 subgroups with wisceral therapy

EXPERIMENTAL

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

2 subgroups with placebo (without intervention)

PLACEBO COMPARATOR

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

Interventions

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.

2 subgroups with wisceral therapy

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.

2 subgroups with placebo (without intervention)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: The study will include women because diseases like endometriosis and genital prolapse are diseases of women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• University of Life Science in Poznan: collaborator

Study Sites (1)

Poznan University of Physical Education

Poznan, 61-871, Poland

RECRUITING

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Małgorzata E Wójcik, Dr

CONTACT

+4895 727 91 00; m.wojcik@awf-gorzow.edu.pl

Anna M Paczkowska, Dr

CONTACT

+4861 285 40 31

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD PT, principal investigator, research manager

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: August 7, 2023
• Study Start: November 14, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

PL (1)