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Biomechanical Assessment of Spinal Posture in Girls With Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT03802474
Recruitment Status : Unknown
Verified September 2018 by HAhmed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
HAhmed, Cairo University

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


Condition or disease
Primary Dysmenorrhea

Detailed Description:

Primary dysmenorrhea is defined as painful menses in women with a normal pelvic anatomy. Adolescent girls tend to have a higher prevalence of primary dysmenorrhoea than older women, as primary dysmenorrhoea can improve with age.Asymmetry in upright posture is associated with various outcomes, such as the decreased loading of the affected side in stroke; degenerative changes of the hip, knee, and ankle joints and spine; or a leg length discrepancy.restriction of movement of the lumbosacral vertebrae, body fluid increases within the pelvis as well as contraction of the uterus leading to the intensification of the menstrual pain. 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.

One handred 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.

  1. Personal data: All data will be recorded in a recording data sheet.
  2. Formetric Raster stereography: It will be used to assess spinal configuration (kyphotic angle, lordotic angle, pelvic inclination, trunk inclination and pelvic tilting) during menstruation.
  3. Leg length discrepancy Tape measure can be used to measure the true leg length from the anterior superior iliac spine to the medial malleolus. The functional leg length is measured from the umbilicus to medial malleolus.
  4. Inclinometer can be used to measure range of motion of lumbar spines.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Biomechanical Assessment of Spinal Posture in Girls With Primary Dysmenorrhea
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Trunk inclination [ Time Frame: 1month ]

    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).


  2. Kyphotic angle [ Time Frame: 1 month ]
    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.

  3. lateral deviation [ Time Frame: 1 month ]
    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

  4. lordotic angle [ Time Frame: 1 month ]
    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

  5. pelvic inclination [ Time Frame: 1 month ]
    this is calculated as the mean torsion of the DLand DR surface normals

  6. pelvic tilt [ Time Frame: 1 month ]
    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

  7. pelvic torsion [ Time Frame: 1 month ]
    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.


Secondary Outcome Measures :
  1. leg lenght discripancy [ Time Frame: 1 months ]
    True leg length is measured from the anterior superior iliac spine to the medial malleolus. The functional leg length is measured from the umbilicus to medial malleolus.


Other Outcome Measures:
  1. Trunk flexion [ Time Frame: 1 month ]
    Flexion describes a bending movement that decreases the angle between a segment and its proximal segment

  2. Trunk extention [ Time Frame: 1 month ]
    Extention describes a straightening movement that increases the angle between body parts

  3. trunk lateral flexion [ Time Frame: 1 month ]
    Lateral flexion describes bending movement of a body part in the lateral direction, that is to say sidewards. It can be performed either to the right or to the left side.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Additional Information:

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Responsible Party: HAhmed, lecture of biomechanics, Cairo University
ClinicalTrials.gov Identifier: NCT03802474    
Other Study ID Numbers: P.T.REC/012/002074
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms