<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/NCT04455659</url>
  </required_header>
  <id_info>
    <org_study_id>1720</org_study_id>
    <nct_id>NCT04455659</nct_id>
  </id_info>
  <brief_title>Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.</brief_title>
  <acronym>TENS</acronym>
  <official_title>Impact of Adding Transcutaneous Electrical Nerve Stimulation to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia.</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>Yes</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>
      Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were&#xD;
      randomly assigned either into experimental group (26 patients) received TENS plus the&#xD;
      traditional physical therapy program( including range of motion exercise, stretching exercise&#xD;
      of obturator internus muscle, clam shell exercise, relaxation exercise and underwater&#xD;
      exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received&#xD;
      only the traditional physical therapy exercise for the same period of time. Intensity of pain&#xD;
      by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake&#xD;
      are measured pre and post treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">May 25, 2020</completion_date>
  <primary_completion_date type="Actual">May 25, 2020</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>Pain intensity (NRS)</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>Numeric Rating Scale (NRS) for pain is a one-dimensional measure of pain intensity in adults, including those with chronic pain .It is an instrument tool to measure the intensity of pain, Numerical pain rating scale consists an 11-point numeric scale with 0 representing &quot;no pain&quot; and 10 representing extreme pain (Worst possible pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum cortisol level</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>A venous blood sample of 8 CC was taken at the morning, centrifuged and stored at 20ºC till analyzed, Normal cortisol level ranged from 9-25 µg/dL at morning and patients with painful conditions tended to have higher than normal SCL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of Etodolac Intake (ELI) in mg</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>It was done before and after the treatment program</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Pudendal Neuralgia</condition>
  <arm_group>
    <arm_group_label>TENS + Conventional physical therapy exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional physical therapy exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trans-cutaneous Electrical Nerve Stimulation</intervention_name>
    <description>TENS that was applied once daily, three times per week for 8 weeks. Each treatment session was conducted for 20 minutes, two electrodes were positioned over the perineal area between anus and scrotum on the Centrum tendineum, while the other two electrodes were applied under the buttocks medially at the level of the ischial spines (medial to the ischial spines bilaterally) with the patient in comfortable supine hook-lying position with abducted hips. to prevent burn beneath the electrodes, the surface area of the electrode should be equal to or greater than 4 cm2 to minimize the heat production. In addition, to decrease the current density between electrodes, the inter-electrode distance was less than the cross sectional area of the electrode</description>
    <arm_group_label>TENS + Conventional physical therapy exercise</arm_group_label>
    <other_name>Conventional physical therapy exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional physical therapy exercise</intervention_name>
    <description>physical therapy program for 30 minutes, and 3 times per week for 8 weeks in the form of strengthening exercise, clam - shell exercise, and stretching exercise focusing on obturator internus muscle, range of motion exercise for the hip and pelvis musculature for 30 minute three times a week for consecutive 8 weeks , each type of exercise was performed for a duration of 6 seconds and repeated 10 times</description>
    <arm_group_label>TENS + Conventional physical therapy exercise</arm_group_label>
    <arm_group_label>conventional physical therapy exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male with ages ranged from 30 to 50 years.&#xD;
&#xD;
          -  Suffering from pudendal neuralgia and its intractable perineal pain that persists for&#xD;
             a minimum one month beyond the acute onset.&#xD;
&#xD;
          -  Pelvic pain with sitting that relived by standing or toilet sitting.&#xD;
&#xD;
          -  Anal pain, dyspareunia and genital pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who had history of skin malignancy.&#xD;
&#xD;
          -  Diabetic,&#xD;
&#xD;
          -  Sensory disorders,&#xD;
&#xD;
          -  Circulatory insufficiency&#xD;
&#xD;
          -  Acute infection of the treatment area,&#xD;
&#xD;
          -  Renal failure&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>12322</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hadaya Mosaad</investigator_full_name>
    <investigator_title>Lecturer , department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Pudendal Neuralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>we will share study protocol after 6 months from publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>After 6 months from publication.</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT04455659
org study id: 1720
nct id: NCT04455659
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fifty two male participants, 30-50 years old, suffering from chronic pudendal neuralgia were
      randomly assigned either into experimental group (26 patients) received TENS plus the
      traditional physical therapy program( including range of motion exercise, stretching exercise
      of obturator internus muscle, clam shell exercise, relaxation exercise and underwater
      exercise) 3 sessions per week for 8 successive weeks, or control group (26 patients) received
      only the traditional physical therapy exercise for the same period of time. Intensity of pain
      by Verbal rating scale (VRS) as well as Serum cortisol level (SCL)and Etodolac level intake
      are measured pre and post treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain intensity (NRS)
time frame: 8 weeks of treatment
description: Numeric Rating Scale (NRS) for pain is a one-dimensional measure of pain intensity in adults, including those with chronic pain .It is an instrument tool to measure the intensity of pain, Numerical pain rating scale consists an 11-point numeric scale with 0 representing "no pain" and 10 representing extreme pain (Worst possible pain)
measure: Serum cortisol level
time frame: 8 weeks of treatment
description: A venous blood sample of 8 CC was taken at the morning, centrifuged and stored at 20ºC till analyzed, Normal cortisol level ranged from 9-25 µg/dL at morning and patients with painful conditions tended to have higher than normal SCL
measure: Calculation of Etodolac Intake (ELI) in mg
time frame: 8 weeks of treatment
description: It was done before and after the treatment program
arm group label: TENS + Conventional physical therapy exercise
arm group type: Experimental
arm group label: conventional physical therapy exercise
arm group type: Active Comparator
intervention type: Device
intervention name: Trans-cutaneous Electrical Nerve Stimulation
description: TENS that was applied once daily, three times per week for 8 weeks. Each treatment session was conducted for 20 minutes, two electrodes were positioned over the perineal area between anus and scrotum on the Centrum tendineum, while the other two electrodes were applied under the buttocks medially at the level of the ischial spines (medial to the ischial spines bilaterally) with the patient in comfortable supine hook-lying position with abducted hips. to prevent burn beneath the electrodes, the surface area of the electrode should be equal to or greater than 4 cm2 to minimize the heat production. In addition, to decrease the current density between electrodes, the inter-electrode distance was less than the cross sectional area of the electrode
arm group label: TENS + Conventional physical therapy exercise
other name: Conventional physical therapy exercise
intervention type: Procedure
intervention name: Conventional physical therapy exercise
description: physical therapy program for 30 minutes, and 3 times per week for 8 weeks in the form of strengthening exercise, clam - shell exercise, and stretching exercise focusing on obturator internus muscle, range of motion exercise for the hip and pelvis musculature for 30 minute three times a week for consecutive 8 weeks , each type of exercise was performed for a duration of 6 seconds and repeated 10 times
arm group label: TENS + Conventional physical therapy exercise
arm group label: conventional physical therapy exercise
criteria: 
gender: Male
gender based: Yes
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hadaya Mosaad
investigator title: Lecturer , department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university.
mesh term: Neuralgia
mesh term: Pudendal Neuralgia
sharing ipd: Yes
ipd description: we will share study protocol after 6 months from publication.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: After 6 months from publication.