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

NCT05957601 | Unknown

• 1 other identifier: 14/07/2023
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Floor Disorders; Temporomandibular Joint Disorders

Keywords

pelvic floor; temporomandibular disorders

Outcome Measures

Primary Outcomes (8)

• Evaluation of pelvic floor dysfunction

  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).

  Baseline

• Evaluation of temporomandibular joint dysfunction

  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

  Baseline

• Evaluation of pelvic floor muscle activation

  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

  Baseline

• Evaluation of masseter muscle activation

  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

  Baseline

• Evaluation of sacroiliac joint mobility

  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.

  Baseline

• Evaluation of temporomandibular range of motion

  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

  Baseline

• Evaluation of pelvic pain

  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.

  Baseline

• Evaluation of temporomandibular joint pain

  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.

  Baseline

Secondary Outcomes (5)

• Evaluation of the strength of the muscles that are thought to be related and located on the Deep Anterior Facial Line

  Baseline

• Evaluation of flexibility

  Baseline

• Evaluation of cervical range of motion

  Baseline

• Evaluation of trigger points

  Baseline

• Evaluation of depression

  Baseline

Study Arms (1)

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.

Other: No intervention was made as it was a descriptive epidemiological study.

Interventions

No intervention was made as it was a descriptive epidemiological study. OTHER

No intervention was made as it was a descriptive epidemiological study.

Women with pelvic floor dysfunction or healthy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: The study was carried out only on women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All women with pelvic floor dysfunction or healthy who met the inclusion criteria were included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• Istanbul Training and Research Hospital: collaborator

Study Sites (1)

Istanbul Research and Training Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• Saito ET, Akashi PM, Sacco Ide C. Global body posture evaluation in patients with temporomandibular joint disorder. Clinics (Sao Paulo). 2009;64(1):35-9. doi: 10.1590/s1807-59322009000100007.

  PMID: 19142549 RESULT

• Garstka AA, Brzozka M, Bitenc-Jasiejko A, Ardan R, Gronwald H, Skomro P, Lietz-Kijak D. Cause-Effect Relationships between Painful TMD and Postural and Functional Changes in the Musculoskeletal System: A Preliminary Report. Pain Res Manag. 2022 Feb 28;2022:1429932. doi: 10.1155/2022/1429932. eCollection 2022.

  PMID: 35265232 RESULT

• Tim S, Mazur-Bialy AI. The Most Common Functional Disorders and Factors Affecting Female Pelvic Floor. Life (Basel). 2021 Dec 14;11(12):1397. doi: 10.3390/life11121397.

  PMID: 34947928 RESULT

• Toprak Celenay S, Akbayrak T, Kaya S, Ekici G, Beksac S. Validity and reliability of the Turkish version of the Pelvic Floor Distress Inventory-20. Int Urogynecol J. 2012 Aug;23(8):1123-7. doi: 10.1007/s00192-012-1729-8. Epub 2012 Mar 29.

  PMID: 22456806 RESULT

• Kaya S, Akbayrak T, Beksac S. Comparison of different treatment protocols in the treatment of idiopathic detrusor overactivity: a randomized controlled trial. Clin Rehabil. 2011 Apr;25(4):327-38. doi: 10.1177/0269215510385481. Epub 2010 Oct 13.

  PMID: 20943711 RESULT

• Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofac Pain. 2008 Summer;22(3):219-30.

  PMID: 18780535 RESULT

• Fridlund AJ, Cacioppo JT. Guidelines for human electromyographic research. Psychophysiology. 1986 Sep;23(5):567-89. doi: 10.1111/j.1469-8986.1986.tb00676.x. No abstract available.

  PMID: 3809364 RESULT

• Sahin D, Kaya Mutlu E, Sakar O, Ates G, Inan S, Taskiran H. The effect of the ischaemic compression technique on pain and functionality in temporomandibular disorders: A randomised clinical trial. J Oral Rehabil. 2021 May;48(5):531-541. doi: 10.1111/joor.13145. Epub 2021 Jan 21.

  PMID: 33411952 RESULT

• Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.

  PMID: 11871683 RESULT

MeSH Terms

Conditions

Pelvic Floor Disorders; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Türkan Akbayrak, Prof. Dr.

  Hacettepe University

  STUDY CHAIR

Central Study Contacts

Duygu Şahin Altaç, PT, M.Sc.

CONTACT

+905535244074; fztduygusahin@gmail.com

Türkan Akbayrak, Prof. Dr.

CONTACT

+905326587236; takbayrak@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: May 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: February 15, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)