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Collegamenti funzionali tra l'articolazione temporo-mandibolare e il bacino in ginecologia (TMJ and Pelvis)

20 settembre 2026 aggiornato da: Małgorzata Wójcik, Poznan University of Physical Education

Relazioni funzionali tra l'articolazione temporo-mandibolare e il bacino nelle donne con malattie ginecologiche di prolasso genitale ed endometriosi

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Anna M Paczkowska, Dr
  • Numero di telefono: 12 +4861 285 40 31

Luoghi di studio

      • Poznan, Polonia, 61-871
        • Reclutamento
        • Poznan University of Physical Education
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

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.

Comparatore placebo: 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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
NRS
Lasso di tempo: 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.

Time point one: before starting visceral therapy and placebo, 1 st week
platforms
Lasso di tempo: 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.

Time point one: before starting visceral therapy and placebo,1 st week
postural pattern by Halla-Wernhama-Littlejohna
Lasso di tempo: 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.

Time point one: before starting visceral therapy and placeb1 st weeko,
pelvic type assessment
Lasso di tempo: 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.

Time point one: before starting visceral therapy and placebo,1 st week
CromWell (measurement of oral dilation)
Lasso di tempo: 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.

Time point one: before starting visceral therapy and placebo,1 st week
standarised questonarie by Kulesa-Morawiecka et al.
Lasso di tempo: 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.

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.
Lasso di tempo: 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.

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.
Lasso di tempo: Time point one: before starting visceral therapy and placebo,1 st week

Each patient will complete a questionnaire.

Time point one: before starting visceral therapy and placebo,1 st week
visceral techniques and placebo
Lasso di tempo: 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.

1 st week, 2nd week, 3rd week,4th week, 5 week
Masseter Muscles Tension
Lasso di tempo: 2023-2025

The device was developed by the authors (PAT 2568 W.132167; patent W.132167). Its construction consists of two parallel beams between which strain gauges are placed to record their deformation under applied compressive force. The signal from the strain gauges was transmitted to a force meter, which displayed the result in mass units (kilograms). The recorded result was entered into an Excel spreadsheet. Measurements were performed under both eyes-open and eyes-closed conditions. Each measurement lasted 30 seconds. A 5-minute rest interval was applied between the eyes-open and eyes-closed measurements

2023-2025

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
NRS
Lasso di tempo: 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.

Time point two: after visceral therapy and placebo, 5th week
platforms
Lasso di tempo: 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.

Time point two: after visceral therapy and placebo, 5th week
postural pattern by Halla-Wernhama-Littlejohna
Lasso di tempo: 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.

Time point two: after visceral therapy and placebo, 5th week
pelvic type assessment
Lasso di tempo: 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.

Time point two: after visceral therapy and placebo,5 th week
CromWell (measurement of oral dilation)
Lasso di tempo: 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.

Time point two: after visceral therapy and placebo, 5th week
standarised questonarie by Kulesa-Morawiecka et al.
Lasso di tempo: 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.

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.
Lasso di tempo: 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.

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.
Lasso di tempo: Time point two: after visceral therapy and placebo, 5th week

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

Time point two: after visceral therapy and placebo, 5th week
World Health Organization Quality of Life BREF (WHOQOL-BREF)
Lasso di tempo: Time point two: after visceral therapy and placebo, 5th week

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 novembre 2023

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

28 giugno 2023

Primo inviato che soddisfa i criteri di controllo qualità

29 luglio 2023

Primo Inserito (Effettivo)

7 agosto 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 305/23

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .