xml: <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/NCT06031649</url>
    </required_header>
    <id_info>
      <org_study_id>Lumbar Paraspinal Muscles</org_study_id>
      <nct_id>NCT06031649</nct_id>
    </id_info>
    <brief_title>Lumbar Paraspinal Muscular Properties After Cesarean Delivery</brief_title>
    <official_title>Lumbar Paraspinal Muscular Properties After Cesarean Delivery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>South Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South Valley University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The biomechanical characteristics of lumbar paraspinal muscles may give us insight into&#xD;
        different lower back dysfunctions in postpartum mothers after cesarean section.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stiffness and elasticity are two mechanical characteristics of the muscles, whereas&#xD;
        relaxation time and creeping are two viscoelastic characteristics.&#xD;
  &#xD;
        Different studies investigated the mechanical properties of lumbar paraspinal muscles in&#xD;
        numerous musculoskeletal conditions, however, no previous studies investigated these&#xD;
        characteristics after cesarean section, which is associated with high prevalence of lower&#xD;
        back pain when compared with normal delivery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 28, 2021</start_date>
    <completion_date type="Actual">February 15, 2022</completion_date>
    <primary_completion_date type="Actual">January 29, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Lumbar Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m.</measure>
      <time_frame>6-12 weeks after cesarean section</time_frame>
      <description>muscular stiffness refers to muscle resistance against forces that deform it.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lumbar Paraspinal Muscles Elasticity, measured by the MyotonPRO device in a relative unit</measure>
      <time_frame>6-12 weeks after cesarean section</time_frame>
      <description>Muscular Elasticity refers to the muscular ability to return to its original shape after the removal of tensional forces.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lumbar Paraspinal Muscles Stress Relaxation Time, measured by the MyotonPRO device in milliseconds</measure>
      <time_frame>6-12 weeks after cesarean section</time_frame>
      <description>relaxation time is a viscoelastic characteristic of the muscles, it refers to the time taken to return to the original shape after the removal of the deformative forces.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lumbar Paraspinal Muscles Creep, measured by the MyotonPRO device in a relative unit</measure>
      <time_frame>6-12 weeks after cesarean section</time_frame>
      <description>Muscular creep refers to the muscular ability to lengthen when constant stresses applied to it.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">60</enrollment>
    <condition>Low Back Pain, Mechanical</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <description>30 mother underwent cesarean section</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <description>30 healthy females who were in the control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MyotonPRO device</intervention_name>
      <description>It is a valid and reliable device for measuring the muscular mechanical properties</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
      <other_name>Myotonometry</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          60 females participated in this research, aged between 20 and 34 years old. They were free&#xD;
          of specific lower back disorders. They were recruited from the outpatient clinics of South&#xD;
          Valley Hospitals&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women who experienced cesarean section at least for one time&#xD;
  &#xD;
            -  Women Who are free of specific lower back disorders&#xD;
  &#xD;
            -  Women who are below 34 years old and above 20 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who experienced normal vaginal birth&#xD;
  &#xD;
            -  Women who complain of a specific lower back disorder&#xD;
  &#xD;
            -  Women who are above 34 years old or below 20 years old&#xD;
  &#xD;
            -  Women who have a body mass index above 30 Kg/m2&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>A study in the scope of physiotherapy for women's health</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>34 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of physical therapy, South Valley University</name>
        <address>
          <city>Qinā</city>
          <state>Qena</state>
          <zip>83523</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.</citation>
      <PMID>28005829</PMID>
    </reference>
    <reference>
      <citation>Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.</citation>
      <PMID>34721664</PMID>
    </reference>
    <reference>
      <citation>Parikh S, Suchi J. Prevalence of low back pain and its impact on quality of life in post-partum women. International Journal of Scientific Research. 2016; 7:14342-8.</citation>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>South Valley University</investigator_affiliation>
      <investigator_full_name>Mohamed Gamal Abouelyazeed Ali</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy for Women's Health</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031649
  org study id: Lumbar Paraspinal Muscles
  nct id: NCT06031649
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The biomechanical characteristics of lumbar paraspinal muscles may give us insight into
        different lower back dysfunctions in postpartum mothers after cesarean section.
  Stiffness and elasticity are two mechanical characteristics of the muscles, whereas
        relaxation time and creeping are two viscoelastic characteristics.
  
        Different studies investigated the mechanical properties of lumbar paraspinal muscles in
        numerous musculoskeletal conditions, however, no previous studies investigated these
        characteristics after cesarean section, which is associated with high prevalence of lower
        back pain when compared with normal delivery.
  observational model: Cohort
  time perspective: Retrospective
  measure: Lumbar Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m.
  time frame: 6-12 weeks after cesarean section
  description: muscular stiffness refers to muscle resistance against forces that deform it.
  measure: Lumbar Paraspinal Muscles Elasticity, measured by the MyotonPRO device in a relative unit
  time frame: 6-12 weeks after cesarean section
  description: Muscular Elasticity refers to the muscular ability to return to its original shape after the removal of tensional forces.
  measure: Lumbar Paraspinal Muscles Stress Relaxation Time, measured by the MyotonPRO device in milliseconds
  time frame: 6-12 weeks after cesarean section
  description: relaxation time is a viscoelastic characteristic of the muscles, it refers to the time taken to return to the original shape after the removal of the deformative forces.
  measure: Lumbar Paraspinal Muscles Creep, measured by the MyotonPRO device in a relative unit
  time frame: 6-12 weeks after cesarean section
  description: Muscular creep refers to the muscular ability to lengthen when constant stresses applied to it.
  arm group label: Group A
  description: 30 mother underwent cesarean section
  arm group label: Group B
  description: 30 healthy females who were in the control group
  intervention type: Device
  intervention name: MyotonPRO device
  description: It is a valid and reliable device for measuring the muscular mechanical properties
  arm group label: Group A
  arm group label: Group B
  other name: Myotonometry
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: A study in the scope of physiotherapy for women's health
  minimum age: 20 Years
  maximum age: 34 Years
  facility: 
  country: Egypt
  citation: Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.
  PMID: 28005829
  citation: Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.
  PMID: 34721664
  citation: Parikh S, Suchi J. Prevalence of low back pain and its impact on quality of life in post-partum women. International Journal of Scientific Research. 2016; 7:14342-8.
  responsible party type: Principal Investigator
  investigator affiliation: South Valley University
  investigator full name: Mohamed Gamal Abouelyazeed Ali
  investigator title: Lecturer of Physical Therapy for Women's Health
  mesh term: Low Back Pain