Pelvic PainNCT04077775
Lumbopelvic Biomechanical Variables and TMJ Kinematics Changes in Pregnant Women: A Case-Control Study
An observational study of Pelvic Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The relationship between the pelvis and stomatognathic system: Various rationales for the relationship between the spine or pelvis and TMJ have been found. These theories include fascial, myological interrelationships, referred pain patterns and facilitating tonic neck reflexes involving inter segmental spinal… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- assesment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2021to 11 May 2022
- 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 40 years
- Women only
- Adult
Study population: 30 women will participate in this study, thirty women diagnosed as having cyclic pelvic pain and thirty women diagnosed as having non cyclic pelvic pain thirty women normal women will not having pelvic pain. They will be selected from outpatient clinic of obstetrics and Gynaecology department in El-Hosary family health Centre. All participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in the study
Who may be able to join
- The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs.
Who cannot join
- Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality. Major jaw abnormality. Any jaw orthotics or prosthesis. Missing teeth.
Trial locations and contacts
1 site in 1 country.
About this study
The relationship between the pelvis and stomatognathic system:
Various rationales for the relationship between the spine or pelvis and TMJ have been found. These theories include fascial, myological interrelationships, referred pain patterns and facilitating tonic neck reflexes involving inter segmental spinal pathways. A contributing mechanism could be the relationship between how TMJ occlusion, head position and body posture relate to the body's natural neurological visual/vestibular righting mechanism (Blum, 2004).
There is a Correlation between the facial axis together with the lordotic angle and the pelvic inclination, the inner gonial angle and the mandibular plane with the lordotic angle and the pelvic inclination, as well as the facial depth with the pelvic inclination showed a significant correlation (Carsten et al., 2007).
- Conditions
- Pelvic Pain
- Being tested
- assesment
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assesmentDiagnostic test
assesment
| Study group | Role | What they receive |
|---|---|---|
| Study group (group A): | Study group (group ) Diagnostic Test: Study group (group A)24 women who have cyclic CPP
I) Pelvic tilt angle:
The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately while the woman was in standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer Receives: Diagnostic Test: assesment | |
| Study group(group B): | included 20 women who have non-cyclic CPP and the other 16 women of the participants were normal I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately. In contrast, the woman was in a standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer Diagnostic Test: Study group (group A) | |
| Control group (group C): | 16 women of the participants were normal and considered the control group I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately while the woman was in standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
BMI in kg/m^2
Measured: 3 months
Satisfaction assessed by the VAS
Degrees of menstrual pain will be assessed using a VAS, which was a method of representing subjects' pain on a 10 cm linear scale. Score of 0 meant 'no pain' and 10 meant 'worst pain'. Tomeasure specific symptoms, such as the s
Measured: 3 months
pelvic tilt in degrees:
The blocks are released and the rods are placed over the crest of the ilium. The blocks are then pressed firmly toward the midline. Read the angle from the level. If the gauge reads over 21/2°, the result is listed as positive.Anterior pelvic tilting angle: PALM was used for measuring pelvic tilting angle. A mark was put on a point just inferior to ASIS; another mark was put just inferior to PSIS. The callipers of the PALM were put on these two points
Measured: 3 months
jaw movement
Maximal vertical mouth opening (MIO):
From sitting position, with the use of the calliper, the distance between the incisal edges along the midline of the upper and lower central incisors without pain was measured, by placing one end of the poley gauge against the incisal edge of one of the upper central incisors, and the other end against the incisal edge of the opposing lower incisor.
The distance recorded in millimeters, the subjects was instructed to" open your mouth as wide as possible without causing pain or discomfort". The poley gauge was sterilized with antiseptic solution before and after each measure
Measured: 3 months
Spinal curves Measurement
spinal inclinations
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start4 Oct 2021
- Primary completion1 Feb 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rovan mohamed saad elbesh, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077775
- Sponsor's protocol ID
- P.T.REC/012/001888
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2019
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbopelvic Biomechanical Variables and TMJ Kinematics Changes in Pregnant Women: A Case-Control Study
- ClinicalTrials.gov ID
- NCT04077775
- Acronym / sponsor ID
- P.T.REC/012/001888
- Conditions
- Pelvic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 4 Sep 2019 (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 relationship between the pelvis and stomatognathic system:
Various rationales for the relationship between the spine or pelvis and TMJ have been found. These theories include fascial, myological interrelationships, referred pain patterns and facilitating tonic neck reflexes involving inter segmental spinal pathways. A contributing mechanism could be the relationship between how TMJ occlusion, head position and body posture relate to the body's natural neurological visual/vestibular righting mechanism (Blum, 2004).
There is a Correlation between the facial axis together with the lordotic angle and the pelvic inclination, the inner gonial angle and the mandibular plane with the lordotic angle and the pelvic inclination, as well as the facial depth with the pelvic inclination showed a significant correlation (Carsten et al., 2007).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group (group A): | – | Diagnostic Test: assesmentStudy group (group ) Diagnostic Test: Study group (group A)24 women who have cyclic CPP I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately while the woman was in standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer |
| Study group(group B): | – | –included 20 women who have non-cyclic CPP and the other 16 women of the participants were normal I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately. In contrast, the woman was in a standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer Diagnostic Test: Study group (group A) |
| Control group (group C): | – | –16 women of the participants were normal and considered the control group I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately while the woman was in standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 30 women will participate in this study, thirty women diagnosed as having cyclic pelvic pain and thirty women diagnosed as having non cyclic pelvic pain thirty women normal women will not having pelvic pain. They will be selected from outpatient clinic of obstetrics and Gynaecology department in El-Hosary family health Centre. All participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in the study
Key inclusion criteria (1 listed)
- The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs.
Key exclusion criteria (1 listed)
- Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality. Major jaw abnormality. Any jaw orthotics or prosthesis. Missing teeth.
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 |
|---|---|---|
| assesmentassesment | Diagnostic test | Study group (group A): |
Primary outcome
body mass index
Time frame: 3 months
BMI in kg/m^2
Satisfaction assessed by the VAS
Time frame: 3 months
Degrees of menstrual pain will be assessed using a VAS, which was a method of representing subjects' pain on a 10 cm linear scale. Score of 0 meant 'no pain' and 10 meant 'worst pain'. Tomeasure specific symptoms, such as the s
pelvic tilt in degrees:
Time frame: 3 months
The blocks are released and the rods are placed over the crest of the ilium. The blocks are then pressed firmly toward the midline. Read the angle from the level. If the gauge reads over 21/2°, the result is listed as positive.Anterior pelvic tilting angle: PALM was used for measuring pelvic tilting angle. A mark was put on a point just inferior to ASIS; another mark was put just inferior to PSIS. The callipers of the PALM were put on these two points
jaw movement
Time frame: 3 months
Maximal vertical mouth opening (MIO): From sitting position, with the use of the calliper, the distance between the incisal edges along the midline of the upper and lower central incisors without pain was measured, by placing one end of the poley gauge against the incisal edge of one of the upper central incisors, and the other end against the incisal edge of the opposing lower incisor. The distance recorded in millimeters, the subjects was instructed to" open your mouth as wide as possible without causing pain or discomfort". The poley gauge was sterilized with antiseptic solution before and after each measure
Spinal curves Measurement
Time frame: 3 months
spinal inclinations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Sep 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2024.