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/NCT05979116</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004050</org_study_id>
      <nct_id>NCT05979116</nct_id>
    </id_info>
    <brief_title>Effect of Abdominal Myofascial Release on Pain and Functional Outcomes of Neck in Females With Cesarean Section</brief_title>
    <official_title>Effect of Abdominal Myofascial Release on Pain and Functional Outcomes of Neck in Females With Cesarean Section</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigate the effect of abdominal myofascial release on pain, ROM and functional&#xD;
        abilities of neck in females with CS scar.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        irty females with neck pain will participate in this study. Subjects will receive treatment&#xD;
        session of thirty minutes in length in order to minimize tissue irritation and avoid&#xD;
        increased tension of the scar area, which would counter the goal of the session.&#xD;
  &#xD;
        Treatment sessions will be provided biweekly for two weeks apart in order to allow&#xD;
        physiological and biomechanical healing time between treatment sessions.&#xD;
  &#xD;
        MFR techniques will be employed to release the caesarean scar and myofascia of the DFL of&#xD;
        each subject.&#xD;
  &#xD;
        The depth of the scar in this study takes us through all the layers from the skin to the&#xD;
        uterus, following the surgical incision procedure.&#xD;
  &#xD;
        MFR was the primary treatment applied to the accessible structure of the patients' DFL,&#xD;
        through Myers's MFR techniques of DFL. MFR in its simplest form targeted restoration of&#xD;
        mobility of myofascial and fascial layers from within, and with the surrounding structure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>a single group study as a study that consists of only a single group of subjects included in the study design, in which all subjects received a single intervention and the outcomes are assessed over time .</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain level measurement</measure>
      <time_frame>2 weeks</time_frame>
      <description>The pain level of each subject will be assessed before participation and after the end of the treatment by using NRS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Scar mobility</measure>
      <time_frame>2 weeks</time_frame>
      <description>Subjects will lay supine on a plinth with arms at their sides and legs straight. Marks were made on the CS scar at 2.5 cm intervals. This resulted in from 5 to 8 measurement points along the scar, The examiner will use the marks to measure tissue extensibility in millimeters (mm) in each of four directions: superior/left/inferior/right by using adheremeter</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pressure pain threshold</measure>
      <time_frame>2 weeks</time_frame>
      <description>Pressure pain tolerance is defined as the force at which the subject asked for pressure to stop due to pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Neck ROM</measure>
      <time_frame>2 weeks</time_frame>
      <description>Neck ROM will be measured in a standardized sitting position to remove errors and movement compensation. The subjects will be asked for sitting with their back straight. Subject's ankles, knees and hips were positioned at right angle and arms were folded across the chest to minimize thoracic movement, with tongue depressor can be held between teeth for reference.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional disability index</measure>
      <time_frame>2 weeks</time_frame>
      <description>The NDI is adapted from Oswestry Low Back Pain Disability Questionnaire. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cesarean Section</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>this study group will receive abdominal myofascial release</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>myofascial release</intervention_name>
      <description>MFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure. MFR techniques utilized with the cases include different variations of application: 1. Muscle was stroked in a long</description>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Female patients suffering from chronic neck pain since more than 3 months.&#xD;
  &#xD;
            2. They underwent CS since at least 2 year before entry into study.&#xD;
  &#xD;
            3. Not suffering from neck pain before CS&#xD;
  &#xD;
            4. Their age will range from 20 to 35 years.&#xD;
  &#xD;
            5. They will be primiparous&#xD;
  &#xD;
            6. Body mass index (BMI) will range from 20-30 kg/m2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy.&#xD;
  &#xD;
            2. BMI over 30 kg/m2.&#xD;
  &#xD;
            3. Less than six months after CS.&#xD;
  &#xD;
            4. History of pathologies resulting in weakening of connective tissue (diabetes,&#xD;
               neoplasms, rheumatic illnesses).&#xD;
  &#xD;
            5. Any abdominal surgeries other than caesarean sections.&#xD;
  &#xD;
            6. Any head or neck trauma.&#xD;
  &#xD;
            7. Skin irritation/inﬂammation at the site of scar.&#xD;
  &#xD;
            8. Any spinal deformity as kyphosis or scoliosis.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amel youssef</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Asmaa khalil</last_name>
      <phone>01004032103</phone>
      <email>dr.asmaakhalil@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cairo university</name>
        <address>
          <city>Giza</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <link>
      <url>http://pubmed.ncbi.nlm.nih.gov/28167179/</url>
      <description>Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/18307483/</url>
      <description>Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey</description>
    </link>
    <results_reference>
      <citation>Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.</citation>
      <PMID>28167179</PMID>
    </results_reference>
    <results_reference>
      <citation>Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.</citation>
      <PMID>18307483</PMID>
    </results_reference>
    <results_reference>
      <citation>Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.</citation>
      <PMID>32471194</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Asmaa Khalil Mohamed Khalil</investigator_full_name>
      <investigator_title>assistant lecturer</investigator_title>
    </responsible_party>
    <keyword>cesarean section</keyword>
    <keyword>myofascial release</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05979116
  org study id: P.T.REC/012/004050
  nct id: NCT05979116
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  To investigate the effect of abdominal myofascial release on pain, ROM and functional
        abilities of neck in females with CS scar.
  irty females with neck pain will participate in this study. Subjects will receive treatment
        session of thirty minutes in length in order to minimize tissue irritation and avoid
        increased tension of the scar area, which would counter the goal of the session.
  
        Treatment sessions will be provided biweekly for two weeks apart in order to allow
        physiological and biomechanical healing time between treatment sessions.
  
        MFR techniques will be employed to release the caesarean scar and myofascia of the DFL of
        each subject.
  
        The depth of the scar in this study takes us through all the layers from the skin to the
        uterus, following the surgical incision procedure.
  
        MFR was the primary treatment applied to the accessible structure of the patients' DFL,
        through Myers's MFR techniques of DFL. MFR in its simplest form targeted restoration of
        mobility of myofascial and fascial layers from within, and with the surrounding structure.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: a single group study as a study that consists of only a single group of subjects included in the study design, in which all subjects received a single intervention and the outcomes are assessed over time .
  primary purpose: Treatment
  masking: None (Open Label)
  measure: pain level measurement
  time frame: 2 weeks
  description: The pain level of each subject will be assessed before participation and after the end of the treatment by using NRS
  measure: Scar mobility
  time frame: 2 weeks
  description: Subjects will lay supine on a plinth with arms at their sides and legs straight. Marks were made on the CS scar at 2.5 cm intervals. This resulted in from 5 to 8 measurement points along the scar, The examiner will use the marks to measure tissue extensibility in millimeters (mm) in each of four directions: superior/left/inferior/right by using adheremeter
  measure: Pressure pain threshold
  time frame: 2 weeks
  description: Pressure pain tolerance is defined as the force at which the subject asked for pressure to stop due to pain
  measure: Neck ROM
  time frame: 2 weeks
  description: Neck ROM will be measured in a standardized sitting position to remove errors and movement compensation. The subjects will be asked for sitting with their back straight. Subject's ankles, knees and hips were positioned at right angle and arms were folded across the chest to minimize thoracic movement, with tongue depressor can be held between teeth for reference.
  measure: Functional disability index
  time frame: 2 weeks
  description: The NDI is adapted from Oswestry Low Back Pain Disability Questionnaire. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability).
  arm group label: study group
  arm group type: Experimental
  description: this study group will receive abdominal myofascial release
  intervention type: Other
  intervention name: myofascial release
  description: MFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure. MFR techniques utilized with the cases include different variations of application: 1. Muscle was stroked in a long
  arm group label: study group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amel youssef
  role: Principal Investigator
  affiliation: Cairo University
  last name: Asmaa khalil
  phone: 01004032103
  email: dr.asmaakhalil@yahoo.com
  facility: 
  country: Egypt
  url: http://pubmed.ncbi.nlm.nih.gov/28167179/
  description: Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study
  url: https://pubmed.ncbi.nlm.nih.gov/18307483/
  description: Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey
  citation: Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.
  PMID: 28167179
  citation: Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.
  PMID: 18307483
  citation: Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.
  PMID: 32471194
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Asmaa Khalil Mohamed Khalil
  investigator title: assistant lecturer
  sharing ipd: No