Pelvic Floor DisordersNCT05957601
The Relationship Between the Parameters Affecting the Functionality of the Pelvic Floor and the Temporomandibular Joint
An observational study of Pelvic Floor Disorders and Temporomandibular Joint Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Temporomandibular Joint Disorders
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All women with pelvic floor dysfunction or healthy who met the inclusion criteria were included in the study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Research and Training Hospital
Istanbul
Duygu Şahin Altaç, PT, M.Sc, +90553 524 40 74
Duygu Şahin Altaç, PT, M.Sc
About this study
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).
Read the 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.
- Being tested
- No intervention was made as it was a descriptive epidemiological study.
- Keywords
- pelvic floor, temporomandibular disorders
- Medical subject headings
- Pelvic Floor Disorders, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was made as it was a descriptive epidemiological study.Other
No intervention was made as it was a descriptive epidemiological study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention was made as it was a descriptive epidemiological study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
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)
Measured: Baseline
Evaluation of flexibility
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.
Measured: Baseline
Evaluation of cervical range of motion
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
Measured: Baseline
Evaluation of trigger points
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".
Measured: Baseline
Evaluation of depression
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start15 May 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Istanbul Training and Research Hospital
- Responsible party
- Principal investigator, Turkan Akbayrak, Hacettepe University
- Investigators
- Türkan Akbayrak, Prof. Dr., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957601
- Sponsor's protocol ID
- 14/07/2023
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19142549Garstka 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.
PubMed 35265232Tim 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.
PubMed 34947928Toprak 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.
PubMed 22456806Kaya 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.
PubMed 20943711Ohrbach 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.
PubMed 18780535Fridlund 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.
PubMed 3809364Sahin 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.
PubMed 33411952Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
PubMed 11871683
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Parameters Affecting the Functionality of the Pelvic Floor and the Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT05957601
- Acronym / sponsor ID
- 14/07/2023
- Keywords
- pelvic floor, temporomandibular disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Istanbul Training and Research Hospital
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pelvic floor dysfunction or healthy | – | Other: No intervention was made as it was a descriptive epidemiological study.All women who met the inclusion criteria, whether pelvic floor dysfunction or healthy, were included. If necessary, grouping can be done during statistics. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women with pelvic floor dysfunction or healthy who met the inclusion criteria were included in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- pregnancy
- menopause
- having the cooperation problem
- history of active cancer
- urinary infection found during evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was made as it was a descriptive epidemiological study.No intervention was made as it was a descriptive epidemiological study. | Other | Women with pelvic floor dysfunction or healthy |
Primary outcome
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.
5 secondary outcomes
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 of flexibility
Time frame: Baseline
Evaluation of cervical range of motion
Time frame: Baseline
Evaluation of trigger points
Time frame: Baseline
Evaluation of depression
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Results publication: PubMed 19142549Saito 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.
- Results publication: PubMed 35265232Garstka 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.
- Results publication: PubMed 34947928Tim 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.
- Results publication: PubMed 22456806Toprak 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.
- Results publication: PubMed 20943711Kaya 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.
- Results publication: PubMed 18780535Ohrbach 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.
- Results publication: PubMed 3809364Fridlund 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.
- Results publication: PubMed 33411952Sahin 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.
- Results publication: PubMed 11871683Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Türkan Akbayrak, Prof. Dr. study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders and Temporomandibular Joint Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duygu Şahin Altaç, PT, M.Sc. (+905535244074, fztduygusahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pelvic floor dysfunction (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957601, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.