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Clinical Trials/NCT05957601
NCT05957601
Recruiting
Not Applicable

The Relationship Between the Parameters Affecting the Functionality of the Pelvic Floor and the Temporomandibular Joint

Hacettepe University1 site in 1 country59 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor Disorders
Sponsor
Hacettepe University
Enrollment
59
Locations
1
Primary Endpoint
Evaluation of masseter muscle activation
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of our study is to examine the relationship between the parameters affecting the pelvic floor and temporomandibular joint (TMJ) functionality and to emphasize the necessity of investigating combined and coordinated exercise approaches in the treatment of dysfunctions that may occur in both specific regions. Our study, which is planned as an epidemiological research, will include 59 women between the ages of 20-50, who applied to the Istanbul Research and Training Hospital, Gynecology and Obstetrics Polyclinic, and volunteered to participate in the study. Assessments include pelvic floor dysfunction, pelvic floor muscle activation, sacroiliac joint mobility, pelvis position, and pain for pelvic floor functionality; temporomandibular joint dysfunction, masseter muscle activation, temporomandibular joint range of motion, position of the mandible and pain for temporomandibular joint funstionlaity; strength of the muscles located on the deep anterior line and thought to be related, flexibility, myofascial trigger points and depression level for mediating factors affecting functionality. After the data are completed, the Kolmogorov-Smirnov test will be applied to determine whether the data fit the normal distribution before starting the statistical analysis. Pearson Correlation test will be applied between dependent variables, independent variables and mediating factors in case the data show normal distribution, and Spearman Correlation test will be applied if it does not show normal distribution.

Significance value will be determined as p<0.05, correlation coefficient between variables r: 0-0.46 (weak); r: 0.5-0.74 (medium); r: will be interpreted as 0.75-1.0 (strong).

Detailed Description

It is known that there are postural changes in individuals with temporomandibular joint dysfunction (TMD). Although studies on this subject have focused mostly on the head, neck and shoulder regions, recent studies have shown that in addition to the opposite direction of head deviation and rectification in the thoracic region in individuals with TMD; It also indicates the presence of hyperlordosis in the lumbar region and posterior rotation of the pelvis. Similarly, Garstka et al. reported that unilateral sacroiliac joint locking was observed in individuals with clicking problems in temporomandibular joint (TMJ). Studies indicate that these effects of TMJ extending to the pelvic girdle occur through the facial pathways and that similar increases in symptoms in these regions are associated with emotional stress. A local change in a muscle segment first lengthens and shortens the muscles in close distance, and then acts on the other muscles on the fascial chain, thanks to the fascial pathways. The deep anterior fascial line starts from the sole of the foot and continues from the back of the leg bones to the inner side of the knee and thigh.While its main pathways pass in front of the hip joint, pelvis and lumbar spine, it proceeds with an alternate branch to the pelvic floor and the first lumbar spine. From the psoas-diaphragm space, it continues along several alternative pathways, covering the entire thorax and viscera, ending in both the neuro- and viscerocranium. Although the relationship of the TMJ with other structures on the connecting pathways has been the subject of many studies by looking at the fascial pathways of the deep anterior fascial line no study has been found that comprehensively examined the parameters of the TMJ and the pelvic floor. However, pelvic floor dysfunctions, urinary incontinence, faecal incontinence, pelvic organ prolapse, chronic pelvic pain, etc. It affects the psychology, physical condition, social life, family life, professional and sexual life of millions of women around the world. This study was planned because the etiology of dysfunctions of both regions is similar, they are located on the same fascial line, and although positive correlation results were obtained for other regions on the same fascial line, there was no previous study examining the relationship between TMJ and pelvic floor. In our study, we aim to emphasize the necessity of investigating combined and coordinated approaches in the prevention and treatment of dysfunctions that may occur in both specific regions by determining the relationship between the functionality of the pelvic floor and the TMJ and the factors affecting the relationship in women.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
February 15, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Turkan Akbayrak

Prof. Dr.

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • having applied to the Istanbul Research and Training Hospital, Gynecology and Obstetrics Polyclinic,
  • being literate
  • being between 20-50 years old
  • volunteering to participate in the study

Exclusion Criteria

  • pregnancy
  • menopause
  • having the cooperation problem
  • history of active cancer
  • urinary infection found during evaluation
  • being in the period of menstruation at the time of assessment
  • having a neurological, orthopedic or serious metabolic disease that may affect pelvic floor functions.

Outcomes

Primary Outcomes

Evaluation of masseter muscle activation

Time Frame: Baseline

Evaluation will be performed with the DuoBravo EMG device. The active electrode will be placed on the most prominent point of the masseter muscle during isometric contraction, and the passive electrode will be placed on the nose. It will be clearly stated that when individuals are given the command "relax", they must completely relax their chewing muscles, and when the "muscle" command is given, they must perform a strong bite. The measurement will be repeated three times, the muscle activation response will be recorded in mV

Evaluation of temporomandibular range of motion

Time Frame: Baseline

Evaluation will be carried out with a ruler. Painless mouth opening, maximum unaided mouth opening, maximum assisted mouth opening, right and left lateral movements will be measured with a ruler, values will be recorded in centimeters

Evaluation of pelvic floor muscle activation

Time Frame: Baseline

Evaluation will be performed with the DuoBravo EMG device. The measurement is taken in the supine position, knees flexed 140 degrees, thighs and feet approximately 30 cm in order to completely relax the pelvic floor muscles, reduce the effect of gravity and eliminate auxiliary muscles such as hip adductors. open and the soles of the feet are in contact with the bed. The passive EMG electrode will be placed on the anterior surface of the thigh, and the active vaginal electrode will be placed intravaginally using a special probe for each patient. It will be clearly stated that when individuals are given the "relax" command, they should completely relax their pelvic floor muscles, and when the "muscle" command is given, they should only tighten the vaginal probe and pull it inward without contracting the hip, thigh and abdominal muscles and without holding their breath. The measurement will be repeated three times, the muscle activation response will be recorded in mV

Evaluation of pelvic floor dysfunction

Time Frame: Baseline

Pelvic Floor Distress Inventory-20: There are 20 questions in total in the scale and these questions consist of 3 subfactors. According to whether they have the complaint or not, the participants say "no(0) or yes"; If the answers are yes, how much the complaint bothers the person will be graded as "insignificant (1), little (2), moderate (3), a lot (4)". The total score of the scale is between 0-300. The higher the score obtained as a result of this questionnaire, the higher the degree of complaint of pelvic floor dysfunction. Pelvic Organ Prolapse Quantification System: According to the hymen reference point, a total of 4 points will be measured: cervix, posterior fornix, anterior and posterior vaginal wall. According to the most distal point of the prolapse, Stage 0 (no prolapses); Stage I, Stage II, Stage III and Stage IV (complete eversion of the total length of the lower genital area).

Evaluation of temporomandibular joint dysfunction

Time Frame: Baseline

Jaw Functional Limitation Scale - 20: Each item is scored between 0-10 on a scale consisting of 20 items. 0 = no restriction and 10 = severe restriction. The total score is between 0 and 200, and a high score indicates a high level of discomfort

Evaluation of sacroiliac joint mobility

Time Frame: Baseline

Standing forward bending test: The physiotherapist will place both thumbs behind the participant, just below the Spina Iliaca Posterior Superior (SIPS). While the patient's knees are bent forward in extension, the physiotherapist will evaluate the asymmetry by following the movement with the thumbs. If one side is displaced more superiorly than the other, the test will be recorded as positive. For positive findings, Gillet's test will be done for confirmation.

Evaluation of pelvic pain

Time Frame: Baseline

Pelvic Pain Impact Questionnaire: The questionnaire consists of 10 questions, but the first eight questions are scored. The range of points to be taken from the questionnaire varies between 1-32. The increase in the score value to be taken indicates that the effect of pelvic pain on the person also increases.

Evaluation of temporomandibular joint pain

Time Frame: Baseline

Graded Chronic Pain Scale Version 2.0: The scoring of 6 items in the scale, which consists of 8 items in total, is made between 0 (no pain) and 10 (maximum pain), while the other 2 questions are evaluated by giving the number of days to the patient. A high score indicates a high level of discomfort.

Secondary Outcomes

  • Evaluation of depression(Baseline)
  • Evaluation of flexibility(Baseline)
  • Evaluation of the strength of the muscles that are thought to be related and located on the Deep Anterior Facial Line(Baseline)
  • Evaluation of cervical range of motion(Baseline)
  • Evaluation of trigger points(Baseline)

Study Sites (1)

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