Postpartum PainNCT04077801
Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain: An Observational Case-control Study
An observational study of Postpartum Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Pain
- What is being tested?
- diagnostic test, Postpartum pain and Visual analogue scale
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Sep 2019to 5 Feb 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
- Adult
Study population: 75 women will participate in this study, The selected cases divide into a study group(A) included 44 women who have CPP and group (B) included 31 women of the participants were normal and considered the control group. 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
Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.
Read the detailed description
Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.
- Conditions
- Postpartum Pain
- Being tested
- diagnostic test, Postpartum pain, Visual analogue scale
- Keywords
- Pelvic girdle Pain, lumbopelvic angles, pelvic parameters, and temporomandibular joint disorders.
- Medical subject headings
- Pelvic Girdle Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic testDiagnostic test
diagnostic test
Postpartum painDiagnostic test
test
Visual analogue scaleOther
test TMJ /pelvic angle/lumber angle
| Study group | Role | What they receive |
|---|---|---|
| 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 Postpartum pain Intervention 'Visual analogue scale' Receives: Diagnostic Test: diagnostic test; Diagnostic Test: Postpartum pain; Other: Visual analogue scale | |
| Control group (group B): | 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 Postpartum pain Intervention 'Visual analogue scale' Receives: Diagnostic Test: diagnostic test; Diagnostic Test: Postpartum pain; Other: Visual analogue scale |
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
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
lateral deviation 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
lumber angle-pelvic inclination by mm
Measured: 3 months
Satisfaction assessed by the VAS
Degrees of 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
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 start8 Sep 2019
- Primary completion1 Jan 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum 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
- Cross-sectional
- Enrolment
- 75 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
- NCT04077801
- Sponsor's protocol ID
- P.T.REC/012/005284
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2019
- Last updated
- 19 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 19 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: An Observational Case-control Study
- ClinicalTrials.gov ID
- NCT04077801
- Acronym / sponsor ID
- P.T.REC/012/005284
- Conditions
- Postpartum Pain
- Keywords
- Pelvic girdle Pain, lumbopelvic angles, pelvic parameters, and temporomandibular joint disorders.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 5 Feb 2020 (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.
Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.
Detailed description
Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (group A) | – | Diagnostic Test: diagnostic test, Diagnostic Test: Postpartum pain, Other: Visual analogue scaleMaximal 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 Postpartum pain Intervention 'Visual analogue scale' |
| Control group (group B): | – | Diagnostic Test: diagnostic test, Diagnostic Test: Postpartum pain, Other: Visual analogue scaleMaximal 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 Postpartum pain Intervention 'Visual analogue scale' |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 75 women will participate in this study, The selected cases divide into a study group(A) included 44 women who have CPP and group (B) included 31 women of the participants were normal and considered the control group. 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 |
|---|---|---|
| diagnostic testdiagnostic test | Diagnostic test | Control group (group B):, Study group (group A) |
| Postpartum paintest | Diagnostic test | Control group (group B):, Study group (group A) |
| Visual analogue scaletest TMJ /pelvic angle/lumber angle | Other | Control group (group B):, Study group (group A) |
Primary outcome
body mass index
Time frame: 3 months
BMI in kg/m^2
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
lateral deviation 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
lumber angle-pelvic inclination by mm
Satisfaction assessed by the VAS
Time frame: 3 months
Degrees of 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
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 19 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 Postpartum 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 19 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 19 Sep 2024.