Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-14

Study Completion Date

2026-09-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prolapse; Female Endometriosis-related Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Visceral therapy

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No