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Recruiting NCT05978414

Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

No phase Interventional Prolapse; Female Endometriosis-related Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visceral therapy, Placebo.
Who it may be relevant to
Registry conditions: Prolapse; Female, Endometriosis-related Pain. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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:

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • NRS [Time frame: Time point one: before starting visceral therapy and placebo, 1 st week]
  • platforms [Time frame: Time point one: before starting visceral therapy and placebo,1 st week]
  • postural pattern by Halla-Wernhama-Littlejohna [Time frame: Time point one: before starting visceral therapy and placeb1 st weeko,]
  • pelvic type assessment [Time frame: Time point one: before starting visceral therapy and placebo,1 st week]
  • CromWell (measurement of oral dilation) [Time frame: Time point one: before starting visceral therapy and placebo,1 st week]
  • standarised questonarie by Kulesa-Morawiecka et al. [Time frame: 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. [Time frame: 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. [Time frame: Time point one: before starting visceral therapy and placebo,1 st week]
  • visceral techniques and placebo [Time frame: 1 st week, 2nd week, 3rd week,4th week, 5 week]
Secondary outcome measures (9)
  • NRS [Time frame: Time point two: after visceral therapy and placebo, 5th week]
  • platforms [Time frame: Time point two: after visceral therapy and placebo, 5th week]
  • postural pattern by Halla-Wernhama-Littlejohna [Time frame: Time point two: after visceral therapy and placebo, 5th week]
  • pelvic type assessment [Time frame: Time point two: after visceral therapy and placebo,5 th week]
  • CromWell (measurement of oral dilation) [Time frame: Time point two: after visceral therapy and placebo, 5th week]
  • standarised questonarie by Kulesa-Morawiecka et al. [Time frame: Time point two: after visceral therapy and placebo, 5th 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. [Time frame: Time point two: after visceral therapy and placebo, 5th week]
  • 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]
  • World Health Organization Quality of Life BREF (WHOQOL-BREF) [Time frame: Time point two: after visceral therapy and placebo, 5th week]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Poznan University of Physical Education — Poznan

Identifiers

NCT: NCT05978414 · 305/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗