Pelvic PainbiomechanicalNCT03740932
Biomechanical Changes in Women With Chronic Pelvic Pain
An observational study of Pelvic Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic pelvic pain (CPP), a frequent complaint in clinical gynaecology, is defined as cyclic or acyclic pain located in the pelvis, persisting for 6 months or more, and severe enough to cause functional incapacity that requires medical or surgical treatment (or both). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Study group (group A)
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Sep 2019to 11 Apr 2020
- 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
- Healthy volunteers accepted
- Adult
Study population: 90 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.
Show all 9Show fewer
- Major jaw abnormality.
- Any jaw orthotics or prosthesis.
- Missing teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain
Chronic pelvic pain (CPP), a frequent complaint in clinical gynaecology, is defined as cyclic or acyclic pain located in the pelvis, persisting for 6 months or more, and severe enough to cause functional incapacity that requires medical or surgical treatment (or both). Chronic pelvic pain is the reason for approximately 10% of all gynaecologic consultations
Read the detailed description
Women who showed an imbalance of the pelvis also experienced greater pain. A possible explanation for this is that the change in the position of the uterus, due to the imbalance of the pelvis, prompted an excessive amount of prostaglandin to be secreted. When the spinal alignment of women who had intense menstrual pain was put back to normal, the pain was alleviated. The level of tension in the ligaments and nerves connecting the sacral vertebrae and the uterus is the cause off the menstrual pain. Due to the abnormal restriction of movement of the lumbosacral vertebrae, body fluid increase within the pelvis as wells contraction of the uterus leading to the intensification of the menstrual pain.
Stabilization of anterior and lateral pelvic curves through exercise or osteopathic manipulative techniques that utilizes techniques of muscle energy, balanced ligamentous tension, myofascial release, strain and counterstrain to assist muscles to keep the spine upright and sufficiently flexible to support good posture . Correct posture involves a straight spine, which maintains the natural curve of the spine in the human body. Correct posture minimizes the strain on the human body by maintaining balance of the muscles and skeleton. This balanced musculoskeletal state protects the supporting structures in the body and prevents damage or progressive deformation in all positions, including standing, lying down, and sitting. Additionally, correct posture implies not inclining the body forward, backward, left, or right.
The temporomandibular joint is surrounded by ligaments, muscles, nerves, and blood vessels. The masticatory muscles enable mouth opening and closing, lateral movement, and forward and backward movement of the mouth, and excessive tension or imbalance of muscles can limit the joint movements, possibly resulting in limited ROM. Thus, it can be surmised that the imbalance in the spinal muscles caused the imbalance in the temporomandibular muscles and limited TMJ mobility.
- Conditions
- Pelvic Pain
- Being tested
- Study group (group A)
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study group (group A)Diagnostic test
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 millimetres, 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
| Study group | Role | What they receive |
|---|---|---|
| Study group (group A): | It will consist of 30 subjects who will have cyclic pelvic pain Receives: Diagnostic Test: Study group (group A) | |
| Study group (group B): | It will consist of 30 subjects who will have non cyclic pelvic pain. Receives: Diagnostic Test: Study group (group A) | |
| Control group (group C): | It will consist of 30 subjects normal women who will not having pelvic pain. Receives: Diagnostic Test: Study group (group A) |
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 followed standardized procedure. Initially, with the subject in prone lying, reference points were marked at the left and right posterior superior iliac spines (PSIS) and at the intersection of the line joining them over the sacral surface and the vertical line of the spine. Also marked were the interspaces of L5-S1, T12-LI and TI-T2. All measurements of spinal inclinations were taken with the subject in erect standing, with feet together, hands by the sides, head erect and eyes focused directly ahead.For the sagittal curves of the spine, the inclinometer was placed along the slope of the vertebrae at each of the levels of the three marked interspaces, so that the zero reading of the inclinometer matched the marked point. The vertically hanging needle of the inclinometer indicated the angles of inclination of these three levels. From these values, the angles of lordosis and kyphosis were determined
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 posted14 Nov 2018
- Study start8 Sep 2019
- Primary completion1 Apr 2020
- Study completion11 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 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
- NCT03740932
- Sponsor's protocol ID
- P.T.REC/012/001887
- Acronym
- biomechanical
- Status last verified
- Sep 2024
- First submitted
- 2 Nov 2018
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamal EE, Hamada HA, Ashour RS, Yousef AM, Elbesh RM. Biomechanical changes in females with poly cystic ovarian syndrome: a case-control study. Sci Rep. 2025 Apr 1;15(1):11190. doi: 10.1038/s41598-025-93481-9.
PubMed 40169684
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
- Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain
- ClinicalTrials.gov ID
- NCT03740932
- Acronym / sponsor ID
- biomechanical / P.T.REC/012/001887
- Conditions
- Pelvic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 11 Apr 2020 (actual)
- First posted
- 14 Nov 2018 (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.
Chronic pelvic pain (CPP), a frequent complaint in clinical gynaecology, is defined as cyclic or acyclic pain located in the pelvis, persisting for 6 months or more, and severe enough to cause functional incapacity that requires medical or surgical treatment (or both). Chronic pelvic pain is the reason for approximately 10% of all gynaecologic consultations
Detailed description
Women who showed an imbalance of the pelvis also experienced greater pain. A possible explanation for this is that the change in the position of the uterus, due to the imbalance of the pelvis, prompted an excessive amount of prostaglandin to be secreted. When the spinal alignment of women who had intense menstrual pain was put back to normal, the pain was alleviated. The level of tension in the ligaments and nerves connecting the sacral vertebrae and the uterus is the cause off the menstrual pain. Due to the abnormal restriction of movement of the lumbosacral vertebrae, body fluid increase within the pelvis as wells contraction of the uterus leading to the intensification of the menstrual pain.
Stabilization of anterior and lateral pelvic curves through exercise or osteopathic manipulative techniques that utilizes techniques of muscle energy, balanced ligamentous tension, myofascial release, strain and counterstrain to assist muscles to keep the spine upright and sufficiently flexible to support good posture . Correct posture involves a straight spine, which maintains the natural curve of the spine in the human body. Correct posture minimizes the strain on the human body by maintaining balance of the muscles and skeleton. This balanced musculoskeletal state protects the supporting structures in the body and prevents damage or progressive deformation in all positions, including standing, lying down, and sitting. Additionally, correct posture implies not inclining the body forward, backward, left, or right.
The temporomandibular joint is surrounded by ligaments, muscles, nerves, and blood vessels. The masticatory muscles enable mouth opening and closing, lateral movement, and forward and backward movement of the mouth, and excessive tension or imbalance of muscles can limit the joint movements, possibly resulting in limited ROM. Thus, it can be surmised that the imbalance in the spinal muscles caused the imbalance in the temporomandibular muscles and limited TMJ mobility.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group (group A): | – | Diagnostic Test: Study group (group A)It will consist of 30 subjects who will have cyclic pelvic pain |
| Study group (group B): | – | Diagnostic Test: Study group (group A)It will consist of 30 subjects who will have non cyclic pelvic pain. |
| Control group (group C): | – | Diagnostic Test: Study group (group A)It will consist of 30 subjects normal women who will not having pelvic pain. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 90 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 (4 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 (9 listed)
- Bone disease.
- Discogenic state with radiculopathy or not.
- Systemic disease of musculoskeletal system.
- Any sensory problems.
- Previous vertebral fractures.
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 |
|---|---|---|
| Study group (group A)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 millimetres, 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 | Diagnostic test | Control group (group C):, Study group (group A):, Study group (group B): |
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 followed standardized procedure. Initially, with the subject in prone lying, reference points were marked at the left and right posterior superior iliac spines (PSIS) and at the intersection of the line joining them over the sacral surface and the vertical line of the spine. Also marked were the interspaces of L5-S1, T12-LI and TI-T2. All measurements of spinal inclinations were taken with the subject in erect standing, with feet together, hands by the sides, head erect and eyes focused directly ahead.For the sagittal curves of the spine, the inclinometer was placed along the slope of the vertebrae at each of the levels of the three marked interspaces, so that the zero reading of the inclinometer matched the marked point. The vertically hanging needle of the inclinometer indicated the angles of inclination of these three levels. From these values, the angles of lordosis and kyphosis were determined
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.
- Derived from this study: PubMed 40169684Kamal EE, Hamada HA, Ashour RS, Yousef AM, Elbesh RM. Biomechanical changes in females with poly cystic ovarian syndrome: a case-control study. Sci Rep. 2025 Apr 1;15(1):11190. doi: 10.1038/s41598-025-93481-9.
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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 4 inclusion and 9 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?
On the ClinicalTrials.gov record for NCT03740932, which also lists 1 linked publication.
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.