Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740932
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
HAhmed, Cairo University

Brief Summary:
Chronic pelvic pain (CPP), a frequent complaint in clinical gynaecology, is defined as cyclic or acyclic pain located in the pelvis, persisting for 6 months or more, and severe enough to cause functional incapacity that requires medical or surgical treatment (or both). Chronic pelvic pain is the reason for approximately 10% of all gynaecologic consultations

Condition or disease Intervention/treatment
Pelvic Pain Diagnostic Test: Study group (group A)

Detailed Description:

Women who showed an imbalance of the pelvis also experienced greater pain. A possible explanation for this is that the change in the position of the uterus, due to the imbalance of the pelvis, prompted an excessive amount of prostaglandin to be secreted. When the spinal alignment of women who had intense menstrual pain was put back to normal, the pain was alleviated. The level of tension in the ligaments and nerves connecting the sacral vertebrae and the uterus is the cause off the menstrual pain. Due to the abnormal restriction of movement of the lumbosacral vertebrae, body fluid increase within the pelvis as wells contraction of the uterus leading to the intensification of the menstrual pain.

Stabilization of anterior and lateral pelvic curves through exercise or osteopathic manipulative techniques that utilizes techniques of muscle energy, balanced ligamentous tension, myofascial release, strain and counterstrain to assist muscles to keep the spine upright and sufficiently flexible to support good posture . Correct posture involves a straight spine, which maintains the natural curve of the spine in the human body. Correct posture minimizes the strain on the human body by maintaining balance of the muscles and skeleton. This balanced musculoskeletal state protects the supporting structures in the body and prevents damage or progressive deformation in all positions, including standing, lying down, and sitting. Additionally, correct posture implies not inclining the body forward, backward, left, or right.

The temporomandibular joint is surrounded by ligaments, muscles, nerves, and blood vessels. The masticatory muscles enable mouth opening and closing, lateral movement, and forward and backward movement of the mouth, and excessive tension or imbalance of muscles can limit the joint movements, possibly resulting in limited ROM. Thus, it can be surmised that the imbalance in the spinal muscles caused the imbalance in the temporomandibular muscles and limited TMJ mobility.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Effect of Biomechanical Alignment and Jaw Movement on Females With Pelvic Pain
Estimated Study Start Date : July 23, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Group/Cohort Intervention/treatment
Study group (group A):
It will consist of 30 subjects who will have cyclic pelvic pain
Diagnostic Test: 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


Study group (group B):
It will consist of 30 subjects who will have non cyclic pelvic pain.
Diagnostic Test: 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


Control group (group C):
It will consist of 30 subjects normal women who will not having pelvic pain.
Diagnostic Test: 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





Primary Outcome Measures :
  1. body mass index [ Time Frame: 3 months ]
    BMI in kg/m^2

  2. Satisfaction assessed by the VAS [ Time Frame: 3 months ]
    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. 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

  4. jaw movement [ Time Frame: 3 months ]

    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


  5. Spinal curves Measurement [ Time Frame: 3 months ]
    spinal inclinations followed standardized procedure. Initially, with the subject in prone lying, reference points were marked at the left and right posterior superior iliac spines (PSIS) and at the intersection of the line joining them over the sacral surface and the vertical line of the spine. Also marked were the interspaces of L5-S1, T12-LI and TI-T2. All measurements of spinal inclinations were taken with the subject in erect standing, with feet together, hands by the sides, head erect and eyes focused directly ahead.For the sagittal curves of the spine, the inclinometer was placed along the slope of the vertebrae at each of the levels of the three marked interspaces, so that the zero reading of the inclinometer matched the marked point. The vertically hanging needle of the inclinometer indicated the angles of inclination of these three levels. From these values, the angles of lordosis and kyphosis were determined



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

90 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 (

Criteria

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.

Layout table for additonal information
Responsible Party: HAhmed, lecturer at biomechanicas depatment, Cairo University
ClinicalTrials.gov Identifier: NCT03740932     History of Changes
Other Study ID Numbers: P.T.REC/012/001887
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms