Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain
1 other identifier
observational
30
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 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
November 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2020
CompletedSeptember 21, 2022
September 1, 2022
9 months
September 1, 2019
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Weight-Height Scale
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)
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)
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
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
Study Arms (2)
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).
control group (group B):
It consisted of fifteen subjects who took their medical treatment only (non-steroidal anti-inflammatory drugs (NIAIDS)).
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- The potential participants will be excluded if they meet one of the following criteria:
- Pelvic inflammatory diseases.
- Any pelvic pathological condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Rovan Elbesh
Giza, Egypt
MeSH Terms
Conditions
Condition 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
November 8, 2019
Primary Completion
August 1, 2020
Study Completion
August 11, 2020
Last Updated
September 21, 2022
Record last verified: 2022-09