The Relationship Between the Parameters Affecting the Functionality of the Pelvic Floor and the Temporomandibular Joint
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ClinicalTrials.gov Identifier: NCT05957601 |
Recruitment Status :
Recruiting
First Posted : July 24, 2023
Last Update Posted : July 24, 2023
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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).
Condition or disease | Intervention/treatment |
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Pelvic Floor Disorders Temporomandibular Joint Disorders | Other: No intervention was made as it was a descriptive epidemiological study. |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 59 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 1 Day |
Official Title: | The Relationship Between the Parameters Affecting the Functionality of the Pelvic Floor and the Temporomandibular Joint |
Actual Study Start Date : | May 15, 2023 |
Estimated Primary Completion Date : | September 15, 2023 |
Estimated Study Completion Date : | February 15, 2024 |
Group/Cohort | Intervention/treatment |
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Women with pelvic floor dysfunction or healthy
All women who met the inclusion criteria, whether pelvic floor dysfunction or healthy, were included. If necessary, grouping can be done during statistics.
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Other: No intervention was made as it was a descriptive epidemiological study.
No intervention was made as it was a descriptive epidemiological study. |
- 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 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 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 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 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 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.
- Evaluation of the strength of the muscles that are thought to be related and located on the Deep Anterior Facial Line [ Time Frame: Baseline ]Evaluation will be performed with a LaFayette manual muscle strength measuring device for the tibialis posterior, adductors, iliopsoas, rectus abdominis, trapezius, and sternocleidomastoideus muscles. The measurement response will be recorded in pounds (Ibs)
- Evaluation of flexibility [ Time Frame: Baseline ]
Sit-reach test: It will be used to evaluate the flexibility of hamstring muscles and trunk flexion. In the application of the test, the participant will be asked to sit on the test table with both knees extended, on a hard surface, and to reach for their hands and feet without bending their knees. The distance between the third finger of both hands and the tip of the test table will be measured with a ruler, and the value obtained will be recorded in centimeters.
Trunk lateral flexion test: Participants will be asked to stand with their feet slightly open and parallel to each other, arms to the side of the trunk, and lateral flexion of the trunk. The distance in which the distal of the third finger of the patient was displaced was measured with the help of a tape measure and recorded in centimeters.
- Evaluation of cervical range of motion [ Time Frame: Baseline ]Evaluation will be performed with a goniometer as measurements of cervical flexion, extension, and right-left lateral flexion. The measurement response will be recorded in degrees
- Evaluation of trigger points [ Time Frame: Baseline ]Myofascial trigger points, which are frequently encountered in our body, will be evaluated by palpation (palpation will be done by pressing until the nail turns white, that is, with approximately 4 kilograms). Pain, twitching, and spread of pain over the palpable point are indicative of the presence of a trigger point, and if these symptoms are encountered, the presence of the trigger point will be recorded as "positive".
- Evaluation of depression [ Time Frame: Baseline ]Beck Depression Inventory: In the scale consisting of 21 questions, each question is scored between 0-3. The total score ranges from 0 to 63, and a high score indicates a high level of discomfort.
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Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | The study was carried out only on women. |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05957601
Contact: Duygu Şahin Altaç, PT, M.Sc. | +905535244074 | fztduygusahin@gmail.com | |
Contact: Türkan Akbayrak, Prof. Dr. | +905326587236 | takbayrak@yahoo.com |
Turkey | |
Istanbul Research and Training Hospital | Recruiting |
Istanbul, Turkey | |
Contact: Duygu Şahin Altaç, PT, M.Sc +90553 524 40 74 | |
Principal Investigator: Duygu Şahin Altaç, PT, M.Sc | |
Principal Investigator: Türkan Akbayrak, Prof. Dr. | |
Sub-Investigator: Doruk Cevdi Katlan, M.Sc. | |
Sub-Investigator: Nebahat Uzunay, M.Sc. |
Study Chair: | Türkan Akbayrak, Prof. Dr. | Hacettepe University |
Responsible Party: | Turkan Akbayrak, Prof. Dr., Hacettepe University |
ClinicalTrials.gov Identifier: | NCT05957601 |
Other Study ID Numbers: |
14/07/2023 |
First Posted: | July 24, 2023 Key Record Dates |
Last Update Posted: | July 24, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pelvic floor temporomandibular disorders |
Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Pelvic Floor Disorders Joint Diseases Musculoskeletal Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases |
Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Pregnancy Complications Male Urogenital Diseases |