<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/NCT01686464</url>
  </required_header>
  <id_info>
    <org_study_id>wykq2012</org_study_id>
    <secondary_id>665533</secondary_id>
    <nct_id>NCT01686464</nct_id>
  </id_info>
  <brief_title>A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy</brief_title>
  <official_title>A New Clinical Therapy for Bell's Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy,&#xD;
      called simultaneous &quot;Magnetic and Oxygen Treatment along Meridians and Collaterals&quot; (MOMC),&#xD;
      to treat Bell's Palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between June 1998 and January 2005, a total of 3002 subjects with BP were evaluated, 882&#xD;
      patients fulfilled the inclusion criteria and entered the study.&#xD;
&#xD;
      Patients were randomly assigned to either the prednisone-valacyclovir group(group 1) or the&#xD;
      magnetic-oxygen group(group 2) . Among the 882 patients completing the study,825 patients in&#xD;
      group 1 received prednisone, given as a single dose of 40 mg daily for 5 days; the dose will&#xD;
      then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking&#xD;
      valacyclovir 400 mg in three doses daily for 10 days. 57 patients in group 2 received&#xD;
      magnetic-oxygen treatment:MOMC treatment was given as daily 20 min section for 10 days with&#xD;
      2~3 days of intermission between;Oxygen therapy was given simultaneously at a flow rate of&#xD;
      2~3.0 L / min for the same duration during all acupuncture sections.&#xD;
&#xD;
      Clinical evaluation for the severity of paralysis was performed immediately before and after&#xD;
      the treatment using the facial nerve grading (FNG) scores of House and Brackmann system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 1998</start_date>
  <completion_date type="Actual">January 2005</completion_date>
  <primary_completion_date type="Actual">January 2005</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>House-Brackmann scale</measure>
    <time_frame>the 20th day of completion of the treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">882</enrollment>
  <condition>Bell's Palsy</condition>
  <arm_group>
    <arm_group_label>Magnetic - Oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnetic and Oxygen Treatment for Bell's Palsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>prednisone - valacyclovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>prednisone and valacyclovir treatments for bell palsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prednisone and valacyclovir treatments</intervention_name>
    <description>patients were administered prednisone as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days.</description>
    <arm_group_label>prednisone - valacyclovir</arm_group_label>
    <other_name>prednisone and valacyclovir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic and Oxygen Treatment</intervention_name>
    <description>MOMC treatment was given as daily 20 min section for 10 days with 2~3 days of intermission between. Oxygen therapy was given simultaneously at a flow rate of 2~3.0 L / min for the same duration during all acupuncture sections.</description>
    <arm_group_label>Magnetic - Oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Only patients with complete (or nearly complete) non-recurrent facial paralysis (grade&#xD;
             5-6/6) for more than 1 months&#xD;
&#xD;
          2. the first time to onset the disease&#xD;
&#xD;
          3. on one side of the face paralysis&#xD;
&#xD;
          4. willing to finish the whole observation period&#xD;
&#xD;
          5. with written consent form signed by themselves.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor&#xD;
             which offend temporal bone, cerebral trauma&#xD;
&#xD;
          2. facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel,&#xD;
             liver, kidney, lung, and psychosis&#xD;
&#xD;
          3. patient with Hunt's syndrome&#xD;
&#xD;
          4. pregnant women or women in lactation&#xD;
&#xD;
          5. patients are participating other clinical research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yan L wang, Ph .D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ping Li, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The 4th military medical university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the 4th Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.nlm.nih.gov/medlineplus/bellspalsy.html</url>
    <description>Bell palsy paralysis Acupuncture</description>
  </link>
  <results_reference>
    <citation>Shafshak TS, Essa AY, Bakey FA. The possible contributing factors for the success of steroid therapy in Bell's palsy: a clinical and electrophysiological study. J Laryngol Otol. 1994 Nov;108(11):940-3. doi: 10.1017/s0022215100128580.</citation>
    <PMID>7829945</PMID>
  </results_reference>
  <results_reference>
    <citation>Finsterer J. Management of peripheral facial nerve palsy. Eur Arch Otorhinolaryngol. 2008 Jul;265(7):743-52. doi: 10.1007/s00405-008-0646-4. Epub 2008 Mar 27.</citation>
    <PMID>18368417</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>wang yanliang</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>magnetic</keyword>
  <keyword>oxygen</keyword>
  <keyword>Bell's Palsy</keyword>
  <keyword>acupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bell Palsy</mesh_term>
    <mesh_term>Facial Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valacyclovir</mesh_term>
    <mesh_term>Prednisone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01686464
org study id: wykq2012
secondary id: 665533
nct id: NCT01686464
lead sponsor: 
has dmc: Yes
The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy,
      called simultaneous "Magnetic and Oxygen Treatment along Meridians and Collaterals" (MOMC),
      to treat Bell's Palsy.
Between June 1998 and January 2005, a total of 3002 subjects with BP were evaluated, 882
      patients fulfilled the inclusion criteria and entered the study.

      Patients were randomly assigned to either the prednisone-valacyclovir group(group 1) or the
      magnetic-oxygen group(group 2) . Among the 882 patients completing the study,825 patients in
      group 1 received prednisone, given as a single dose of 40 mg daily for 5 days; the dose will
      then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking
      valacyclovir 400 mg in three doses daily for 10 days. 57 patients in group 2 received
      magnetic-oxygen treatment:MOMC treatment was given as daily 20 min section for 10 days with
      2~3 days of intermission between;Oxygen therapy was given simultaneously at a flow rate of
      2~3.0 L / min for the same duration during all acupuncture sections.

      Clinical evaluation for the severity of paralysis was performed immediately before and after
      the treatment using the facial nerve grading (FNG) scores of House and Brackmann system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: House-Brackmann scale
time frame: the 20th day of completion of the treatment
arm group label: Magnetic - Oxygen
arm group type: Experimental
description: Magnetic and Oxygen Treatment for Bell's Palsy
arm group label: prednisone - valacyclovir
arm group type: Active Comparator
description: prednisone and valacyclovir treatments for bell palsy
intervention type: Drug
intervention name: prednisone and valacyclovir treatments
description: patients were administered prednisone as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days.
arm group label: prednisone - valacyclovir
other name: prednisone and valacyclovir
intervention type: Device
intervention name: Magnetic and Oxygen Treatment
description: MOMC treatment was given as daily 20 min section for 10 days with 2~3 days of intermission between. Oxygen therapy was given simultaneously at a flow rate of 2~3.0 L / min for the same duration during all acupuncture sections.
arm group label: Magnetic - Oxygen
criteria: 
gender: All
minimum age: 10 Years
maximum age: 74 Years
healthy volunteers: No
last name: yan L wang, Ph .D
role: Principal Investigator
affiliation: Wenzhou Medical University
last name: Ping Li, M.D.
role: Study Chair
affiliation: The 4th military medical university
facility: 
country: China
url: http://www.nlm.nih.gov/medlineplus/bellspalsy.html
description: Bell palsy paralysis Acupuncture
citation: Shafshak TS, Essa AY, Bakey FA. The possible contributing factors for the success of steroid therapy in Bell's palsy: a clinical and electrophysiological study. J Laryngol Otol. 1994 Nov;108(11):940-3. doi: 10.1017/s0022215100128580.
PMID: 7829945
citation: Finsterer J. Management of peripheral facial nerve palsy. Eur Arch Otorhinolaryngol. 2008 Jul;265(7):743-52. doi: 10.1007/s00405-008-0646-4. Epub 2008 Mar 27.
PMID: 18368417
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: wang yanliang
investigator title: principal investigator
mesh term: Bell Palsy
mesh term: Facial Paralysis
mesh term: Paralysis
mesh term: Valacyclovir
mesh term: Prednisone