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/NCT06041958</url>
    </required_header>
    <id_info>
      <org_study_id>21-CT12-01(210917-1)</org_study_id>
      <nct_id>NCT06041958</nct_id>
    </id_info>
    <brief_title>Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema</brief_title>
    <official_title>Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zheng-Yu Hoe, MD., PhD.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kaohsiung Veterans General Hospital.</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>
        Lymphedema occurs not only in patients with breast cancer and gynecological cancers but also&#xD;
        in those where lymphatic drainage is obstructed. Accumulation of lymphatic fluid within&#xD;
        tissues results in limb swelling. Additionally, proteins present in lymphatic fluid might&#xD;
        lead to fibrosis within tissues, causing various challenges for patients. The changes in&#xD;
        volume and weight can significantly impact daily life activities such as eating, brushing&#xD;
        teeth, and other routine tasks. Furthermore, it can lead to clothing difficulties and provoke&#xD;
        unwanted attention due to aesthetic concerns.&#xD;
  &#xD;
        Currently, there is no definitive treatment for lymphedema. However, prospective research has&#xD;
        shown promising results in applying extracorporeal shock wave therapy (ESWT), originally used&#xD;
        for musculoskeletal disorders like plantar fasciitis, tennis elbow, frozen shoulder, and&#xD;
        non-union fractures, to lymphedema patients. Similarly, Pulse Electromagnetic Field Therapy&#xD;
        (PEMFT), widely used for pain management and muscle strengthening, has the potential for&#xD;
        treating lymphedema as it can enhance blood circulation and stimulate muscle contractions.&#xD;
  &#xD;
        This research project aims to explore the effectiveness and sustainability of using ESWT and&#xD;
        PEMFT for lymphedema patients. By applying these therapies to lymphedema patients, this study&#xD;
        aims to evaluate their treatment outcomes and long-term effects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There is currently no cure for lymphedema. Literature review revealedextracorporeal shock&#xD;
        wave therapy (previously applied to soft tissue diseases such as plantar fasciitis, tennis&#xD;
        elbow, frozen shoulders, and poor fracture healing) showed positive therapeutic effect for&#xD;
        patients with lymphedema.&#xD;
  &#xD;
        Another widely used therapy for pain treatment and muscle strengthening is Pulse&#xD;
        Electromagnetic Field Therapy (PEMFT), which has the potential to be used in the treatment of&#xD;
        lymphedema due to its ability to increase blood circulation and stimulate muscle&#xD;
        contractions.&#xD;
  &#xD;
        This study design to evaluate the effect of extracorporeal shock wave therapy on patients&#xD;
        with lymphedema, and further explore its therapeutic effect.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 8, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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 (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>circumference</measure>
      <time_frame>every 1 week, through study completion, an average of 1 year</time_frame>
      <description>Limb circumference</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Thickness</measure>
      <time_frame>every 1 week, through study completion, an average of 1 year</time_frame>
      <description>thickness of skin and Subcutaneous tissue</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hardness</measure>
      <time_frame>every 1 week, through study completion, an average of 1 year</time_frame>
      <description>Hardness by shearwave elastography</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Lymphedema</condition>
    <arm_group>
      <arm_group_label>General rehabilitation therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ESWT therapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomly assigned to receive either shockwave therapy or electromagnetic pulse therapy. Once assigned, the treatment method is fixed and continues for 12 weeks. From week 1 to week 12, participants receive either extracorporeal shockwave therapy or electromagnetic pulse therapy three times a week, totaling 36 sessions. After the completion of the 12-week treatment, the general rehabilitation program for lymphedema continues, conducted three times a week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PEFT therapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomly assigned to receive either shockwave therapy or electromagnetic pulse therapy. Once assigned, the treatment method is fixed and continues for 12 weeks. From week 1 to week 12, participants receive either extracorporeal shockwave therapy or electromagnetic pulse therapy three times a week, totaling 36 sessions. After the completion of the 12-week treatment, the general rehabilitation program for lymphedema continues, conducted three times a week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Extracorporeal shock wave therapy</intervention_name>
      <description>2 times/week for 12 weeks</description>
      <arm_group_label>ESWT therapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pulse electromagnetic field therapy</intervention_name>
      <description>2 times/week for 12 weeks</description>
      <arm_group_label>PEFT therapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation</intervention_name>
      <description>2 times/week for 12 weeks</description>
      <arm_group_label>General rehabilitation therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must be at least 20 years old and have no significant cognitive, language&#xD;
               comprehension, or communication issues, be able to understand and follow instructions,&#xD;
               and sign the informed consent form.&#xD;
  &#xD;
            -  Individuals with lymphedema after treatment for breast cancer or gynecologic cancer&#xD;
               are eligible (lymphedema is defined as a circumference difference of &gt;2 cm in the same&#xD;
               location on both limbs).&#xD;
  &#xD;
            -  You must be able to attend follow-up appointments at specific times during the 12&#xD;
               months of the trial, referred by a rehabilitation physician in the outpatient&#xD;
               department.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The affected limb has unhealed open wounds, acute infections, or other conditions&#xD;
               unsuitable for contact-based treatment.&#xD;
  &#xD;
            -  The affected limb has metastatic tumors.&#xD;
  &#xD;
            -  The affected limb has untreated deep vein thrombosis.&#xD;
  &#xD;
            -  Severe clotting abnormalities.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zheng Yu Hoe, Dr</last_name>
      <phone>+886935517631</phone>
      <email>jhoe@vghks.gov.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kaohsiung Veterans General Hospital</name>
        <address>
          <city>Kaohsiung</city>
          <zip>81362</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zheng-Yu Hoe</last_name>
        <phone>+886975581721</phone>
        <email>jhoe@vghks.gov.tw</email>
      </contact>
      <investigator>
        <last_name>Zheng-Yu Hoe</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Kaohsiung Veterans General Hospital.</investigator_affiliation>
      <investigator_full_name>Zheng-Yu Hoe, MD., PhD.</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphedema</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/NCT06041958
  org study id: 21-CT12-01(210917-1)
  nct id: NCT06041958
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Lymphedema occurs not only in patients with breast cancer and gynecological cancers but also
        in those where lymphatic drainage is obstructed. Accumulation of lymphatic fluid within
        tissues results in limb swelling. Additionally, proteins present in lymphatic fluid might
        lead to fibrosis within tissues, causing various challenges for patients. The changes in
        volume and weight can significantly impact daily life activities such as eating, brushing
        teeth, and other routine tasks. Furthermore, it can lead to clothing difficulties and provoke
        unwanted attention due to aesthetic concerns.
  
        Currently, there is no definitive treatment for lymphedema. However, prospective research has
        shown promising results in applying extracorporeal shock wave therapy (ESWT), originally used
        for musculoskeletal disorders like plantar fasciitis, tennis elbow, frozen shoulder, and
        non-union fractures, to lymphedema patients. Similarly, Pulse Electromagnetic Field Therapy
        (PEMFT), widely used for pain management and muscle strengthening, has the potential for
        treating lymphedema as it can enhance blood circulation and stimulate muscle contractions.
  
        This research project aims to explore the effectiveness and sustainability of using ESWT and
        PEMFT for lymphedema patients. By applying these therapies to lymphedema patients, this study
        aims to evaluate their treatment outcomes and long-term effects.
  There is currently no cure for lymphedema. Literature review revealedextracorporeal shock
        wave therapy (previously applied to soft tissue diseases such as plantar fasciitis, tennis
        elbow, frozen shoulders, and poor fracture healing) showed positive therapeutic effect for
        patients with lymphedema.
  
        Another widely used therapy for pain treatment and muscle strengthening is Pulse
        Electromagnetic Field Therapy (PEMFT), which has the potential to be used in the treatment of
        lymphedema due to its ability to increase blood circulation and stimulate muscle
        contractions.
  
        This study design to evaluate the effect of extracorporeal shock wave therapy on patients
        with lymphedema, and further explore its therapeutic effect.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: circumference
  time frame: every 1 week, through study completion, an average of 1 year
  description: Limb circumference
  measure: Thickness
  time frame: every 1 week, through study completion, an average of 1 year
  description: thickness of skin and Subcutaneous tissue
  measure: Hardness
  time frame: every 1 week, through study completion, an average of 1 year
  description: Hardness by shearwave elastography
  arm group label: General rehabilitation therapy
  arm group type: Active Comparator
  description: Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment.
  arm group label: ESWT therapy group
  arm group type: Experimental
  description: Participants are randomly assigned to receive either shockwave therapy or electromagnetic pulse therapy. Once assigned, the treatment method is fixed and continues for 12 weeks. From week 1 to week 12, participants receive either extracorporeal shockwave therapy or electromagnetic pulse therapy three times a week, totaling 36 sessions. After the completion of the 12-week treatment, the general rehabilitation program for lymphedema continues, conducted three times a week.
  arm group label: PEFT therapy group
  arm group type: Experimental
  description: Participants are randomly assigned to receive either shockwave therapy or electromagnetic pulse therapy. Once assigned, the treatment method is fixed and continues for 12 weeks. From week 1 to week 12, participants receive either extracorporeal shockwave therapy or electromagnetic pulse therapy three times a week, totaling 36 sessions. After the completion of the 12-week treatment, the general rehabilitation program for lymphedema continues, conducted three times a week.
  intervention type: Device
  intervention name: Extracorporeal shock wave therapy
  description: 2 times/week for 12 weeks
  arm group label: ESWT therapy group
  intervention type: Device
  intervention name: Pulse electromagnetic field therapy
  description: 2 times/week for 12 weeks
  arm group label: PEFT therapy group
  intervention type: Other
  intervention name: Rehabilitation
  description: 2 times/week for 12 weeks
  arm group label: General rehabilitation therapy
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zheng Yu Hoe, Dr
  phone: +886935517631
  email: jhoe@vghks.gov.tw
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Taiwan
  responsible party type: Sponsor-Investigator
  investigator affiliation: Kaohsiung Veterans General Hospital.
  investigator full name: Zheng-Yu Hoe, MD., PhD.
  investigator title: Principal Investigator
  mesh term: Lymphedema