- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077801
Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain: An Observational Case-control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Giza, Egypt
- Rovan Elbesh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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 (
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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' |
diagnostic test
test
test TMJ /pelvic angle/lumber angle
|
|
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' |
diagnostic test
test
test TMJ /pelvic angle/lumber angle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body mass index
Time Frame: 3 months
|
BMI in kg/m^2
|
3 months
|
|
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
|
3 months
|
|
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 |
3 months
|
|
Spinal curves Measurement
Time Frame: 3 months
|
lumber angle-pelvic inclination by mm
|
3 months
|
|
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
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005284
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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