NCT04077801

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 8, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 1, 2019

Last Update Submit

September 17, 2024

Conditions

Keywords

Pelvic girdle Pain, lumbopelvic angles, pelvic parameters, and temporomandibular joint disorders.

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'

Diagnostic Test: diagnostic testDiagnostic Test: Postpartum painOther: 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'

Diagnostic Test: diagnostic testDiagnostic Test: Postpartum painOther: Visual analogue scale

Interventions

diagnostic testDIAGNOSTIC_TEST

diagnostic test

Control group (group B):Study group (group A)
Postpartum painDIAGNOSTIC_TEST

test

Control group (group B):Study group (group A)

test TMJ /pelvic angle/lumber angle

Control group (group B):Study group (group A)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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 (

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

Study Sites (1)

Rovan Elbesh

Giza, Egypt

Location

MeSH Terms

Conditions

Pelvic Girdle PainTemporomandibular Joint Disorders

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic PainCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

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

Locations