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/NCT05979766</url>
    </required_header>
    <id_info>
      <org_study_id>RiphahIUmib</org_study_id>
      <nct_id>NCT05979766</nct_id>
    </id_info>
    <brief_title>Manual Lymphatic Drainage vs Marian Clark Drainage in Pcs</brief_title>
    <official_title>Effects of Manual Lymphatic Drainage Versus Marian Clark Drainage on Pain and Disability in Patients With Pelvic Congestion Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>No</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>
        Pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the&#xD;
        pelvic region there is a constant hindrance in patient's daily professional and personal life&#xD;
        due to the chronic pain. it can provide a definite way to improve pelvic congestion and&#xD;
        quality of life. In this way it can benefit a large percentage of community females suffering&#xD;
        from pelvic congestion syndrome and disability. This can grow at large length in favour of&#xD;
        patients, clinicians and overall women health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As per researcher's knowledge there are limited researches in which efficacy of manual&#xD;
        lymphatic drainage in pelvic congestion syndrome are analyzed furthermore my comparative&#xD;
        intervention i.e Marian Clark drainage is a rarely used osteopathic technique and not much&#xD;
        studies have been conducted on it. This study helped to in identifying the effect of manual&#xD;
        lymphatic drainage versus Marian Clark drainage on pain and disability in patients with&#xD;
        pelvic congestion syndrome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 5, 2022</start_date>
    <completion_date type="Anticipated">August 2023</completion_date>
    <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Manual lymphatic drainage</measure>
      <time_frame>6 months</time_frame>
      <description>Treatment protocol to group A&#xD;
  It consists of 15 patients who will receive manual lymphatic drainage 4 sessions per week for 12 weeks&#xD;
  Manual Lymph Drainage Techniques for Pelvic Decongestion&#xD;
  Step 1: short neck treatment (supraclavicular fossa or SCF)&#xD;
  Step 2: (two parts: visceral, deep)&#xD;
  Visceral:&#xD;
  Deep: Treatment of the thoracic duct, cisterna Chyli&#xD;
  Deep Abdominal Manual lymphatic drainage&#xD;
  Step-3. Treatment of right Axillary Lymph nodes&#xD;
  Step-4. Establish the Right inguino-Axillary Anastomosis.&#xD;
  Step-5. Decongest the right ipsilateral lower abdomen and suprapubic area&#xD;
  Step-6 Treatment of Left Axillary Lymph nodes&#xD;
  Step-7. Establish the Left inguino-Axillary Anastomosis.&#xD;
  Step-8. Decongest the Let ipsilateral lower abdomen and suprapubic area</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Marian clark drainage</measure>
      <time_frame>6 months</time_frame>
      <description>It consists of 15 patients who will receive Marian clark drainage 4 sessions per week for 12 weeks each session will continue till therapist feels palpable change in congestion in pelvic area medial to Anterior superior Iliac spine.&#xD;
  Stand to the side of the patient&#xD;
  Patient semiprone on all fours&#xD;
  Hook fingers medial to both Anterior superior Iliac spine&#xD;
  Pull hands cephalad (traction)&#xD;
  Patient arches back like a cat&#xD;
  Encourage this movement with cephalad rocking&#xD;
  Repeat for several minutes</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Pelvic Congestive Syndrome</condition>
    <arm_group>
      <arm_group_label>Manual lymphatic drainage vs marian clark drainage</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Manual lymphatic drainage versus marian clark drainage</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Manual lymphatic drainage versus marian clark drainage</intervention_name>
      <description>Manual lymphatic drainage versus marian clark drainage</description>
      <arm_group_label>Manual lymphatic drainage versus marian clark drainage</arm_group_label>
      <arm_group_label>Manual lymphatic drainage vs marian clark drainage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Multiparous women&#xD;
  &#xD;
            -  Age ranging 20 to 50&#xD;
  &#xD;
            -  Ovarian veins &gt;4mm in diameter on Ultrasound Chronic pelvic pain/pressure for more&#xD;
               than 6 months.&#xD;
  &#xD;
            -  Dull, aching or &quot;dragging&quot; pain in the pelvis or lower back, particularly on standing&#xD;
               and worse around the time of your menstrual period.&#xD;
  &#xD;
            -  Pelvic pain that worsens as the day goes on, particularly if much time is spent&#xD;
               standing dyspareunia&#xD;
  &#xD;
            -  Swollen veins in pelvic region, butt, thighs, vulva and vagina.&#xD;
  &#xD;
            -  Associated Irritable bladder/Irritable bowel present&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pelvic pain due to other organic cause like uterine fibroids, Endometriosis, Ovarian&#xD;
               cyst pelvic pain due to neurological or musculoskeletal disorder&#xD;
  &#xD;
            -  Uterine prolapse&#xD;
  &#xD;
            -  Pelvic cancer&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hafiza Neelam Muneeb, Ms</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imran Amjad, Phd</last_name>
      <phone>03324390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Jinnah hospital</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hafiza Neelam Muneeb, PT</last_name>
        <phone>+92 320 4097476</phone>
        <email>hafiza.neelam@riphah.edu.pk</email>
      </contact>
      <investigator>
        <last_name>Maira Imran Butt, MS-WHPT</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hafiza Neelam Muneeb</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <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/NCT05979766
  org study id: RiphahIUmib
  nct id: NCT05979766
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the
        pelvic region there is a constant hindrance in patient's daily professional and personal life
        due to the chronic pain. it can provide a definite way to improve pelvic congestion and
        quality of life. In this way it can benefit a large percentage of community females suffering
        from pelvic congestion syndrome and disability. This can grow at large length in favour of
        patients, clinicians and overall women health.
  As per researcher's knowledge there are limited researches in which efficacy of manual
        lymphatic drainage in pelvic congestion syndrome are analyzed furthermore my comparative
        intervention i.e Marian Clark drainage is a rarely used osteopathic technique and not much
        studies have been conducted on it. This study helped to in identifying the effect of manual
        lymphatic drainage versus Marian Clark drainage on pain and disability in patients with
        pelvic congestion syndrome.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Manual lymphatic drainage
  time frame: 6 months
  description: Treatment protocol to group A
  It consists of 15 patients who will receive manual lymphatic drainage 4 sessions per week for 12 weeks
  Manual Lymph Drainage Techniques for Pelvic Decongestion
  Step 1: short neck treatment (supraclavicular fossa or SCF)
  Step 2: (two parts: visceral, deep)
  Visceral:
  Deep: Treatment of the thoracic duct, cisterna Chyli
  Deep Abdominal Manual lymphatic drainage
  Step-3. Treatment of right Axillary Lymph nodes
  Step-4. Establish the Right inguino-Axillary Anastomosis.
  Step-5. Decongest the right ipsilateral lower abdomen and suprapubic area
  Step-6 Treatment of Left Axillary Lymph nodes
  Step-7. Establish the Left inguino-Axillary Anastomosis.
  Step-8. Decongest the Let ipsilateral lower abdomen and suprapubic area
  measure: Marian clark drainage
  time frame: 6 months
  description: It consists of 15 patients who will receive Marian clark drainage 4 sessions per week for 12 weeks each session will continue till therapist feels palpable change in congestion in pelvic area medial to Anterior superior Iliac spine.
  Stand to the side of the patient
  Patient semiprone on all fours
  Hook fingers medial to both Anterior superior Iliac spine
  Pull hands cephalad (traction)
  Patient arches back like a cat
  Encourage this movement with cephalad rocking
  Repeat for several minutes
  arm group label: Manual lymphatic drainage vs marian clark drainage
  arm group type: Active Comparator
  description: Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome
  arm group label: Manual lymphatic drainage versus marian clark drainage
  arm group type: Active Comparator
  description: Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome
  intervention type: Other
  intervention name: Manual lymphatic drainage versus marian clark drainage
  description: Manual lymphatic drainage versus marian clark drainage
  arm group label: Manual lymphatic drainage versus marian clark drainage
  arm group label: Manual lymphatic drainage vs marian clark drainage
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Hafiza Neelam Muneeb, Ms
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Imran Amjad, Phd
  phone: 03324390125
  email: imran.amjad@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No