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/NCT05969353</url>
    </required_header>
    <id_info>
      <org_study_id>062-23 BNZ</org_study_id>
      <nct_id>NCT05969353</nct_id>
    </id_info>
    <brief_title>Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study</brief_title>
    <official_title>Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study in Participants Who Hospitalized in Department of Internal Medicine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bnai Zion Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bnai Zion Medical Center</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>
        This is a randomized sham controlled study that will include patients hospitalized in the&#xD;
        internal medicine department and the orthopedics department at Bnei Zion Hospital presenting&#xD;
        with pain from various sources with an NRS level equal to or above 4.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or&#xD;
        BFA) one hour before and every 24 hours until discharge.&#xD;
  &#xD;
        If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or&#xD;
        more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated&#xD;
        assessments as above.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 23, 2023</start_date>
    <completion_date type="Anticipated">January 10, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2025</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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>efficacy of BFA</measure>
      <time_frame>two years</time_frame>
      <description>Evaluating the analgesic efficacy of BFA in addition to the standard treatment for pain - Standard of care (SOC) to reduce pain in patients hospitalized in the internal and orthopedic department who experience pain of moderate intensity and above compared to SHAM BFA.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study</condition>
    <arm_group>
      <arm_group_label>sham controlled arm</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>battlefield acupunture</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>accupunture</intervention_name>
      <description>BFA</description>
      <arm_group_label>battlefield acupunture</arm_group_label>
      <arm_group_label>sham controlled arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -1.Pain of skeletal muscle origin (Musculoskeletal MSK)/rheumatological/orthopedic&#xD;
          syndromes 2.Visual Analog Score (VAS) grade 4 or higher before receiving the treatment.&#xD;
  &#xD;
          3.Eligible to participate in the study according to the assessment of the investigator&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pain syndromes of non-muscular bony/rheumatological/orthopedic origin&#xD;
  &#xD;
            2. Planned an MRI next week&#xD;
  &#xD;
            3. An infectious process in the ear planned for acupuncture or a history of sensitivity&#xD;
               to metal&#xD;
  &#xD;
            4. have any participant condition that ' according to the Investigator ' could interfere&#xD;
               with the conduct of the trial -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>shira ginsberg, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>BnaiZion MC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Julia Sterlin</last_name>
      <phone>0528976129</phone>
      <email>JULIA.STERLIN@GMAIL.COM</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shira Ginsberg, MD</last_name>
      <email>shiragins@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>BnaiZion MC</name>
        <address>
          <city>Haifa</city>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Julia Sterlin</last_name>
        <phone>97258976129</phone>
        <email>JULIA.STERLIN@GMAIL.COM</email>
      </contact>
      <contact_backup>
        <last_name>Shira Ginsberg, MD</last_name>
        <phone>97258976129</phone>
        <email>shiragins@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bnai Zion Medical Center</investigator_affiliation>
      <investigator_full_name>shira.ginsberg</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05969353
  org study id: 062-23 BNZ
  nct id: NCT05969353
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized sham controlled study that will include patients hospitalized in the
        internal medicine department and the orthopedics department at Bnei Zion Hospital presenting
        with pain from various sources with an NRS level equal to or above 4.
  All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or
        BFA) one hour before and every 24 hours until discharge.
  
        If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or
        more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated
        assessments as above.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: efficacy of BFA
  time frame: two years
  description: Evaluating the analgesic efficacy of BFA in addition to the standard treatment for pain - Standard of care (SOC) to reduce pain in patients hospitalized in the internal and orthopedic department who experience pain of moderate intensity and above compared to SHAM BFA.
  arm group label: sham controlled arm
  arm group type: Sham Comparator
  arm group label: battlefield acupunture
  arm group type: Active Comparator
  intervention type: Other
  intervention name: accupunture
  description: BFA
  arm group label: battlefield acupunture
  arm group label: sham controlled arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: shira ginsberg, MD
  role: Principal Investigator
  affiliation: BnaiZion MC
  last name: Julia Sterlin
  phone: 0528976129
  email: JULIA.STERLIN@GMAIL.COM
  last name: Shira Ginsberg, MD
  email: shiragins@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Bnai Zion Medical Center
  investigator full name: shira.ginsberg
  investigator title: MD
  sharing ipd: Undecided