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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04077788
Collaborator
(none)
30
9.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: muscle energy technique

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain
Anticipated Study Start Date :
Nov 8, 2019
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 11, 2020

Arms and Interventions

Arm 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: Application of MET for bone of pelvis: I) Pubis: Cranial Os pubis. Caudal os pubis. II) ileum: Anterior ileum. Posterior ileum. External Rotation (In flare) Lesion. Internal Rotation (Out flare) Lesion. III) sacrum: Forward torsion of sacrum. Backward torsion of sacrum. Muscle energy technique for specific muscles of pelvis and spine: Stretch of the Psoas Major. Stretch of the paravertebral muscle. 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: Application of MET for bone of pelvis: I) Pubis: Cranial Os pubis. Caudal os pubis. II) ileum: Anterior ileum. Posterior ileum. External Rotation (In flare) Lesion. Internal Rotation (Out flare) Lesion. III) sacrum: Forward torsion of sacrum. Backward torsion of sacrum. Muscle energy technique for specific muscles of pelvis and spine: Stretch of the Psoas Major. Stretch of the paravertebral muscle. Stretch of the piriforms.

Outcome Measures

Primary Outcome Measures

  1. Weight-Height Scale [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

  2. Visual analogue scale (VAS) [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. Menstrual Distress Questionnaire (MDQ) [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.

  4. jaw movement [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HAhmed, assistant proffesor, Cairo University
ClinicalTrials.gov Identifier:
NCT04077788
Other Study ID Numbers:
  • P.T.REC/012/001889
First Posted:
Sep 4, 2019
Last Update Posted:
Sep 4, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 4, 2019