NCT04077788

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 8, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2020

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

September 1, 2019

Last Update Submit

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).

Other: muscle energy technique

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

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.

Study group (group A):control group (group B):

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

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

Study Sites (1)

Rovan Elbesh

Giza, Egypt

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations