Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain: An Observational Case-control Study
1 other identifier
observational
75
1 country
1
Brief 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. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedStudy Start
First participant enrolled
September 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2020
CompletedSeptember 19, 2024
September 1, 2024
4 months
September 1, 2019
September 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
body mass index
BMI in kg/m\^2
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
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
3 months
Spinal curves Measurement
lumber angle-pelvic inclination by mm
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
3 months
Study Arms (2)
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'
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'
Interventions
test TMJ /pelvic angle/lumber angle
Eligibility Criteria
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 (
You may qualify if:
- \- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Rovan Elbesh
Giza, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
September 1, 2019
First Posted
September 4, 2019
Study Start
September 8, 2019
Primary Completion
January 1, 2020
Study Completion
February 5, 2020
Last Updated
September 19, 2024
Record last verified: 2024-09