NCT03802474

Brief Summary

Dysmenorrhea comes from the Greek word for difficult monthly flow and describes painful menstruation.Primary dysmenorrhea might be caused by spinal misalignment and incompatibility between muscles of the pelvic circumference and soft tissue.Leg Length Discrepancy affects spinal posture. Although, several studies evaluated the relation between spinal alignment, spinal configuration and primary dysmenorrhea, but, there is no previous study investigate the effect of leg length discrepancy on primary dysmenorrhea. So, this study will correlate leg length discrepancy with spinal configuration and primary dysmenorrhea. Statement of the problem: Is there an impact of spinal posture on primary dysmenorrhea in girls? Hypothesis: Null hypothesis: There is no impact of spinal mobility ,spinal configurations and leg length discrepancy on primary dysmenorrhea

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Status
unknown

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

Study Start

First participant enrolled

January 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 14, 2019

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

January 10, 2019

Last Update Submit

January 10, 2019

Conditions

Outcome Measures

Primary Outcomes (7)

  • Trunk inclination

    the trunk inclination refer to the difference in height between VP and DM based on a vertical plane (sagital section). an angle \>2.8 referred to as " Inclination" (I), an angle \<2.8 as "reclination" (R).

    1month

  • Kyphotic angle

    this is the maximum kyphotic angle measured between the surface tangents of the upper inflection point ICT in the vicinity of the VP and the thoracic lumbar inflection point ITL.

    1 month

  • lateral deviation

    the total deviation of the spinal midline from the VP-DM line in the frontal plane , i.e the maximum deflection on the right plus the maximum deflection on the left

    1 month

  • lordotic angle

    this is the maximum lordotic angle measured between the surface tangents of the thoracic-lumbar inflection point ITL and the lower lumbar-sacral inflection point ILS

    1 month

  • pelvic inclination

    this is calculated as the mean torsion of the DLand DR surface normals

    1 month

  • pelvic tilt

    the difference in height of the lumbar dimples, based on a horizontal plane (transverse section ). DR is higher than DL if the angle is positive

    1 month

  • pelvic torsion

    pelvic torsion is calculated from the reciprocal torsion of the surface normals on the two lumbar dimples (vertical components). If the difference angle is positive, then the normal on the right dimple (DR) is up more than on the left dimple.

    1 month

Secondary Outcomes (1)

  • leg lenght discripancy

    1 months

Other Outcomes (3)

  • Trunk flexion

    1 month

  • Trunk extention

    1 month

  • trunk lateral flexion

    1 month

Study Arms (2)

Group A

girls with primary dysmenorrhea subject to three-dimensional analysis of the back will conducted with the 4D formetric device and inclinometer to measure range of motion of spine

Group B

girls with normal painless menstruation without primary dysmenorrhea subject to three-dimensional analysis of the back will conducted with the 4D formetric device and inclinometer to measure range of motion of spine

Eligibility Criteria

Age17 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailshealthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study. All subjects will be recruited from student of faculty of physical therapy, Cairo University.

You may qualify if:

  • Healthy girls with regular menstrual cycles with an average of 28:35 days.
  • Their age will be ranged from 17to 24 years.
  • Their body mass index will be ranged from 20 to 25kg/m2.

You may not qualify if:

  • Girls who have musculoskeletal disorders as low back pain.
  • Girls who have any pelvic or gynecological disorders.
  • History of lower limb injury.
  • Over-weight and obese girls.
  • Thin and underweight girls.
  • Girls with spinal deformities as kyphosis and scoliosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of biomechanics

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 14, 2019

Study Start

January 1, 2019

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

January 14, 2019

Record last verified: 2018-09