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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04077788
Other study ID # P.T.REC/012/001889
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2019
Est. completion date August 11, 2020

Study information

Verified date September 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 11, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Rovan Elbesh Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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