<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03802474</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002074</org_study_id>
    <nct_id>NCT03802474</nct_id>
  </id_info>
  <brief_title>Biomechanical Assessment of Spinal Posture in Girls With Primary Dysmenorrhea</brief_title>
  <official_title>Biomechanical Assessment of Spinal Posture in Girls With Primary Dysmenorrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dysmenorrhea comes from the Greek word for difficult monthly flow and describes painful&#xD;
      menstruation.Primary dysmenorrhea might be caused by spinal misalignment and incompatibility&#xD;
      between muscles of the pelvic circumference and soft tissue.Leg Length Discrepancy affects&#xD;
      spinal posture. Although, several studies evaluated the relation between spinal alignment,&#xD;
      spinal configuration and primary dysmenorrhea, but, there is no previous study investigate&#xD;
      the effect of leg length discrepancy on primary dysmenorrhea. So, this study will correlate&#xD;
      leg length discrepancy with spinal configuration and primary dysmenorrhea.&#xD;
&#xD;
      Statement of the problem:&#xD;
&#xD;
      Is there an impact of spinal posture on primary dysmenorrhea in girls?&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Null hypothesis: There is no impact of spinal mobility ,spinal configurations and leg length&#xD;
      discrepancy on primary dysmenorrhea&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary dysmenorrhea is defined as painful menses in women with a normal pelvic anatomy.&#xD;
      Adolescent girls tend to have a higher prevalence of primary dysmenorrhoea than older women,&#xD;
      as primary dysmenorrhoea can improve with age.Asymmetry in upright posture is associated with&#xD;
      various outcomes, such as the decreased loading of the affected side in stroke; degenerative&#xD;
      changes of the hip, knee, and ankle joints and spine; or a leg length discrepancy.restriction&#xD;
      of movement of the lumbosacral vertebrae, body fluid increases within the pelvis as well as&#xD;
      contraction of the uterus leading to the intensification of the menstrual pain. Although,&#xD;
      several studies evaluated the relation between spinal alignment, spinal configuration and&#xD;
      primary dysmenorrhea, but, there is no previous study investigate the effect of leg length&#xD;
      discrepancy on primary dysmenorrhea. So, this study will correlate leg length discrepancy&#xD;
      with spinal configuration and primary dysmenorrhea.&#xD;
&#xD;
      One handred healthy girls with regular menstrual cycle and are not have any pelvic or&#xD;
      gynecological disorders will be participated in this study. All subjects will be recruited&#xD;
      from student of faculty of physical therapy, Cairo University.&#xD;
&#xD;
        1. Personal data: All data will be recorded in a recording data sheet.&#xD;
&#xD;
        2. Formetric Raster stereography: It will be used to assess spinal configuration (kyphotic&#xD;
           angle, lordotic angle, pelvic inclination, trunk inclination and pelvic tilting) during&#xD;
           menstruation.&#xD;
&#xD;
        3. Leg length discrepancy Tape measure can be used to measure the true leg length from the&#xD;
           anterior superior iliac spine to the medial malleolus. The functional leg length is&#xD;
           measured from the umbilicus to medial malleolus.&#xD;
&#xD;
        4. Inclinometer can be used to measure range of motion of lumbar spines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Trunk inclination</measure>
    <time_frame>1month</time_frame>
    <description>the trunk inclination refer to the difference in height between VP and DM based on a vertical plane (sagital section).&#xD;
an angle &gt;2.8 referred to as &quot; Inclination&quot; (I), an angle &lt;2.8 as &quot;reclination&quot; (R).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kyphotic angle</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lateral deviation</measure>
    <time_frame>1 month</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lordotic angle</measure>
    <time_frame>1 month</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pelvic inclination</measure>
    <time_frame>1 month</time_frame>
    <description>this is calculated as the mean torsion of the DLand DR surface normals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pelvic tilt</measure>
    <time_frame>1 month</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pelvic torsion</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>leg lenght discripancy</measure>
    <time_frame>1 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Trunk flexion</measure>
    <time_frame>1 month</time_frame>
    <description>Flexion describes a bending movement that decreases the angle between a segment and its proximal segment</description>
  </other_outcome>
  <other_outcome>
    <measure>Trunk extention</measure>
    <time_frame>1 month</time_frame>
    <description>Extention describes a straightening movement that increases the angle between body parts</description>
  </other_outcome>
  <other_outcome>
    <measure>trunk lateral flexion</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Primary Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>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</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy girls with regular menstrual cycle and are not have any pelvic or gynecological&#xD;
        disorders will be participated in this study. All subjects will be recruited from student&#xD;
        of faculty of physical therapy, Cairo University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy girls with regular menstrual cycles with an average of 28:35 days.&#xD;
&#xD;
          -  Their age will be ranged from 17to 24 years.&#xD;
&#xD;
          -  Their body mass index will be ranged from 20 to 25kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Girls who have musculoskeletal disorders as low back pain.&#xD;
&#xD;
          -  Girls who have any pelvic or gynecological disorders.&#xD;
&#xD;
          -  History of lower limb injury.&#xD;
&#xD;
          -  Over-weight and obese girls.&#xD;
&#xD;
          -  Thin and underweight girls.&#xD;
&#xD;
          -  Girls with spinal deformities as kyphosis and scoliosis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study</gender_description>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>HAhmed</investigator_full_name>
    <investigator_title>lecture of biomechanics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802474
org study id: P.T.REC/012/002074
nct id: NCT03802474
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Trunk inclination
time frame: 1month
description: 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).
measure: Kyphotic angle
time frame: 1 month
description: 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.
measure: lateral deviation
time frame: 1 month
description: 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
measure: lordotic angle
time frame: 1 month
description: 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
measure: pelvic inclination
time frame: 1 month
description: this is calculated as the mean torsion of the DLand DR surface normals
measure: pelvic tilt
time frame: 1 month
description: 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
measure: pelvic torsion
time frame: 1 month
description: 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.
measure: leg lenght discripancy
time frame: 1 months
description: 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.
measure: Trunk flexion
time frame: 1 month
description: Flexion describes a bending movement that decreases the angle between a segment and its proximal segment
measure: Trunk extention
time frame: 1 month
description: Extention describes a straightening movement that increases the angle between body parts
measure: trunk lateral flexion
time frame: 1 month
description: 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.
arm group label: Group A
description: 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
arm group label: Group B
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study
minimum age: 17 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: HAhmed
investigator title: lecture of biomechanics
mesh term: Dysmenorrhea