Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain

September 19, 2022 updated by: rovan mohamed saad elbesh, Cairo University
Clinical experiences have shown that significant pain regression during a menstrual cycle has been often achieved by the use of spinal manipulative therapy (SMT) indicated in women with primary dysmenorrhea with coexisting functional disorders of lumbosacral (LS) spine. Namely, by activation of the nociceptive and vegetative system, LS spine disorders, before all segmental dysfunction and degenerative changes, can induce referred pain and reflex disturbances of pelvic organs (somatovisceral reflexes). Since significant improvement or disappearance of pain during a menstrual cycle is often achieved with adequate therapy of coexisting vertebral disorders in women with primary dysmenorrhea, it is important to recognise latent or manifest vertebral disorders in dysmenorrheic women using clinical examination (Grgić, 2009).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Rovan Elbesh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

the participants will be divided randomly into two groups equal in numbers study group (group A) and control group (group B).

• Study group (group A): It will consist of fifteen subjects who will receive osteopathic technique six treatment ( sessions) around three cycles two treatment every month first treatment after the end of menstruation.second treatment before the next cycle. In addition to their medical treatment if needed non-steroidal anti-inflammatory drugs (NIAIDS).

• Control group (group B): It will consist of fifteen subjects who will reeive sham treatment,will take their medical treatment only non-steroidal anti- inflammatory drugs (NIAIDS) if needed.

Description

Inclusion criteria:

  • The age of the participants will be ranged from 25 to 35 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:

The potential participants will be excluded if they meet one of the following criteria:

  • Pelvic inflammatory diseases.
  • Any pelvic pathological condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group (group A):
It consisted of fifteen subjects who received muscle energy technique (Mitchell relaxation osteopathic technique). Two sessions per cycle for three cycles before menstruation by one week and after the end of menstruation by one week. In addition to their medical treatment non-steroidal anti-inflammatory drugs (NIAIDS).
Other: muscle energy technique

Muscle energy technique:

  1. Application of MET for bone of pelvis:

    I) Pubis:

    1. Cranial Os pubis.
    2. Caudal os pubis.

    II) ileum:

    1. Anterior ileum.
    2. Posterior ileum.
    3. External Rotation (In flare) Lesion.
    4. Internal Rotation (Out flare) Lesion.

    III) sacrum:

    1. Forward torsion of sacrum.
    2. Backward torsion of sacrum.

  2. Muscle energy technique for specific muscles of pelvis and spine:

    1. Stretch of the Psoas Major.
    2. Stretch of the paravertebral muscle.
    3. Stretch of the piriforms.
control group (group B):
It consisted of fifteen subjects who took their medical treatment only (non-steroidal anti-inflammatory drugs (NIAIDS)).
Other: muscle energy technique

Muscle energy technique:

  1. Application of MET for bone of pelvis:

    I) Pubis:

    1. Cranial Os pubis.
    2. Caudal os pubis.

    II) ileum:

    1. Anterior ileum.
    2. Posterior ileum.
    3. External Rotation (In flare) Lesion.
    4. Internal Rotation (Out flare) Lesion.

    III) sacrum:

    1. Forward torsion of sacrum.
    2. Backward torsion of sacrum.

  2. Muscle energy technique for specific muscles of pelvis and spine:

    1. Stretch of the Psoas Major.
    2. Stretch of the paravertebral muscle.
    3. Stretch of the piriforms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-Height Scale
Time Frame: 3 months

It will be used for measuring the body weight and height of each patient participating in the study to calculate the patient's body mass index (BMI).

Body mass index (BMI) = Weight (Kg
3 months
Visual analogue scale (VAS)
Time Frame: 3 months
ain will be assessed by visual analogue scale. It is 10 cm horizontal line with one end described as (no pain=0) and other end (worst pain=10). It was considered a valid way for assessing pain. It allowed graphic representation and numerical analysis of collected data (Boonstra et al., 2008) (Appendix III).
3 months
Menstrual Distress Questionnaire (MDQ)
Time Frame: 3 months
The MDQ is a 46-item self-report inventory for use in the assessment and treatment of premenstrual and menstrual symptoms. The MDQ can distinguish cyclical from noncyclical changes in physical symptoms, mood and behavior, and arousal.
3 months
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 measur
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2019

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

August 11, 2020

Study Registration Dates

First Submitted

September 1, 2019

First Submitted That Met QC Criteria

September 1, 2019

First Posted (ACTUAL)

September 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/001889

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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