NCT04077775

Brief Summary

The relationship between the pelvis and stomatognathic system: Various rationales for the relationship between the spine or pelvis and TMJ have been found. These theories include fascial, myological interrelationships, referred pain patterns and facilitating tonic neck reflexes involving inter segmental spinal pathways. A contributing mechanism could be the relationship between how TMJ occlusion, head position and body posture relate to the body's natural neurological visual/vestibular righting mechanism (Blum, 2004). There is a Correlation between the facial axis together with the lordotic angle and the pelvic inclination, the inner gonial angle and the mandibular plane with the lordotic angle and the pelvic inclination, as well as the facial depth with the pelvic inclination showed a significant correlation (Carsten et al., 2007).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

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
2.1 years until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 1, 2019

Last Update Submit

September 1, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • body mass index

    BMI in kg/m\^2

    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

    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

    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

    3 months

  • Spinal curves Measurement

    spinal inclinations

    3 months

Study Arms (3)

Study group (group A):

Study group (group ) Diagnostic Test: Study group (group A)24 women who have cyclic CPP I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately while the woman was in standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer

Diagnostic Test: assesment

Study group(group B):

included 20 women who have non-cyclic CPP and the other 16 women of the participants were normal I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately. In contrast, the woman was in a standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer Diagnostic Test: Study group (group A)

Control group (group C):

16 women of the participants were normal and considered the control group I) Pelvic tilt angle: The physiotherapist stood beside the women and found the position of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) accurately while the woman was in standing position. Hence the therapist placed one end arm of PALM inclinometer on ASIS, and the other end arm was placed on PSIS. The pelvic sagittal inclination angle was the angle between the horizontal line and a line passing through the ASIS and PSIS that determined by the bubble level in the PALM inclinometer

Interventions

assesmentDIAGNOSTIC_TEST

assesment

Study group (group A):

Eligibility Criteria

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

30 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

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, 12651, Egypt

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
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

October 4, 2021

Primary Completion

February 1, 2022

Study Completion

May 11, 2022

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations