<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/NCT04488835</url>
  </required_header>
  <id_info>
    <org_study_id>68mm</org_study_id>
    <nct_id>NCT04488835</nct_id>
  </id_info>
  <brief_title>Pulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve</brief_title>
  <official_title>A Comparative Study Between Pulsed Electromagnetic Field Therapy and Transcutaneous Electrical Nerve Stimulation in Management of Post-herpetic Neuralgia of the Sciatic Nerve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Background and purpose: Post-herpetic neuralgia (PHN) is the most frequent chronic&#xD;
      complication of herpes zoster, resulting in post- infectious severe neuropathic pain. Due to&#xD;
      drug resistance severe pain; patients with PHN suffer from reduced physical activities,&#xD;
      social and psychological manifestations as well as decrease in the quality of life. The&#xD;
      purpose of this research was to evaluate the efficacy of pulsed electromagnetic field therapy&#xD;
      (PEMFT) versus transcutaneous electrical nerve stimulation (TENS) in the treatment of&#xD;
      post-herpetic neuralgia of the sciatic nerve.&#xD;
&#xD;
      Methods: In an eight weeks period of treatemnt, 52 patients were randomly and equally&#xD;
      assigned into two groups. Both groups received conventional physical therapy treatment&#xD;
      protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS&#xD;
      application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes&#xD;
      for each session. Assessment performed pre and post intervention using visual analogue scale&#xD;
      (VAS) and estimation of the carbamazepine intake (CMI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2018</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>neuralgia</measure>
    <time_frame>8 weeks</time_frame>
    <description>Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Neuralgia,Postherpetic</condition>
  <arm_group>
    <arm_group_label>TENS Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this group received TENS therapy in addition to routine physical therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEMFT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this group received PEMFT therapy in addition to routine physical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electromagnetic field therapy and transcutaneous electrical nerve stimulation</intervention_name>
    <description>Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).</description>
    <arm_group_label>PEMFT group</arm_group_label>
    <arm_group_label>TENS Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 30-40 years&#xD;
&#xD;
          -  History of herpes zoster more than 90 days&#xD;
&#xD;
          -  Visual analogue scale is greater than or equal 5 out on a scale from 0 to 10&#xD;
&#xD;
          -  All patients were on pain medication &quot;Carbamazepine&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncooperative behavior&#xD;
&#xD;
          -  Intellectual disability to complete the self-evaluation questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marwa Eid, Ass.prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marwa Eid</name>
      <address>
        <city>Cairo</city>
        <zip>2011</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Marwa Eid</investigator_full_name>
    <investigator_title>assistant professor of physical therapy for surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Neuralgia, Postherpetic</mesh_term>
  </condition_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/NCT04488835
org study id: 68mm
nct id: NCT04488835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background and purpose: Post-herpetic neuralgia (PHN) is the most frequent chronic
      complication of herpes zoster, resulting in post- infectious severe neuropathic pain. Due to
      drug resistance severe pain; patients with PHN suffer from reduced physical activities,
      social and psychological manifestations as well as decrease in the quality of life. The
      purpose of this research was to evaluate the efficacy of pulsed electromagnetic field therapy
      (PEMFT) versus transcutaneous electrical nerve stimulation (TENS) in the treatment of
      post-herpetic neuralgia of the sciatic nerve.

      Methods: In an eight weeks period of treatemnt, 52 patients were randomly and equally
      assigned into two groups. Both groups received conventional physical therapy treatment
      protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS
      application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes
      for each session. Assessment performed pre and post intervention using visual analogue scale
      (VAS) and estimation of the carbamazepine intake (CMI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: neuralgia
time frame: 8 weeks
description: Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain
arm group label: TENS Therapy Group
arm group type: Experimental
description: patients in this group received TENS therapy in addition to routine physical therapy
arm group label: PEMFT group
arm group type: Experimental
description: patients in this group received PEMFT therapy in addition to routine physical therapy
intervention type: Other
intervention name: Electromagnetic field therapy and transcutaneous electrical nerve stimulation
description: Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).
arm group label: PEMFT group
arm group label: TENS Therapy Group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 40 Years
healthy volunteers: No
last name: Marwa Eid, Ass.prof.
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Marwa Eid
investigator title: assistant professor of physical therapy for surgery
mesh term: Neuralgia
mesh term: Neuralgia, Postherpetic