<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/NCT03269591</url>
  </required_header>
  <id_info>
    <org_study_id>dr ghada</org_study_id>
    <nct_id>NCT03269591</nct_id>
  </id_info>
  <brief_title>Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea</brief_title>
  <acronym>magnetic</acronym>
  <official_title>Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled&#xD;
      trial in the Egyptian women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Primary dysmenorrhea is one of the most common complaints of women and is also&#xD;
      the most common gynecological problem worldwide. These cramps are recurrent and 90%&#xD;
      adolescent girls and about 50% women suffer from it. Purpose of the study: to determine which&#xD;
      is more effective in alleviating primary dysmenorrhea; pulsed electromagnetic field or&#xD;
      diclofenac drugs. Methodology: The study was a randomized, double-blinded trial, fifty adult&#xD;
      females participated in this study, were divided randomly into two groups equal in numbers:&#xD;
      group (A) received pulsed electromagnetic field applied on pelvic region, 3 times per week&#xD;
      for 3 months, 20 minutes per day and group (B) received diclofenac tablets, 50 mg only with&#xD;
      onset of menstrual pain. All participants in both groups (A and B) were assessed pre- and&#xD;
      post-treatment through measuring progesterone level in the blood, assessment of pain using&#xD;
      visual analogue scale and physical as well as psychological symptoms by using menstrual&#xD;
      symptom questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">October 29, 2016</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>(Participant, Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue scale</measure>
    <time_frame>three months</time_frame>
    <description>was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month); in both groups (A and B) by (16), it is a graphic rating scale with numerical values placed equidistantly along the line. The descriptors and numbers help the subject to place her estimate on line in which (0) mean no pain, (1) equal mild pain, (2) equal moderate pain, (3) mean severe pain and (4) mean unbearable pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progesterone blood level</measure>
    <time_frame>three months</time_frame>
    <description>Sample of blood was taken to detect the level of progesterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menstrual symptom questionnaire</measure>
    <time_frame>three months</time_frame>
    <description>to assess symptoms of dysmenorrhea</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Electromagnetic Field</condition>
  <condition>Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>magnetic therapy device which generate frequency from 5-100 Hz and intensity from 1 to 60 Gauss. Group (A) received 20 min 3 times per week for three month with strength 60 gauss and frequency 50 Hz</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diclofenac tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(50 mg) few hours at the onset of menstruation for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Visual analogue scale</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Progesterone blood level</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sample of blood was taken to detect the level of progesterone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Menstrual symptom questionnaire</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>to assess symptoms of dysmenorrhea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed electromagnetic field</intervention_name>
    <description>EASY Qs portable (by ASA, Italy)</description>
    <arm_group_label>Menstrual symptom questionnaire</arm_group_label>
    <arm_group_label>Progesterone blood level</arm_group_label>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_label>Visual analogue scale</arm_group_label>
    <arm_group_label>diclofenac tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>diclofenac tablets</intervention_name>
    <description>drugs</description>
    <arm_group_label>Menstrual symptom questionnaire</arm_group_label>
    <arm_group_label>Progesterone blood level</arm_group_label>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_label>Visual analogue scale</arm_group_label>
    <arm_group_label>diclofenac tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Visual analogue scale</intervention_name>
    <description>a graphic rating scale</description>
    <arm_group_label>Menstrual symptom questionnaire</arm_group_label>
    <arm_group_label>Progesterone blood level</arm_group_label>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_label>Visual analogue scale</arm_group_label>
    <arm_group_label>diclofenac tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Progesterone blood level</intervention_name>
    <description>blood test</description>
    <arm_group_label>Menstrual symptom questionnaire</arm_group_label>
    <arm_group_label>Progesterone blood level</arm_group_label>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_label>Visual analogue scale</arm_group_label>
    <arm_group_label>diclofenac tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Menstrual symptom questionnaire</intervention_name>
    <description>questionnaire</description>
    <arm_group_label>Menstrual symptom questionnaire</arm_group_label>
    <arm_group_label>Progesterone blood level</arm_group_label>
    <arm_group_label>Pulsed electromagnetic field</arm_group_label>
    <arm_group_label>Visual analogue scale</arm_group_label>
    <arm_group_label>diclofenac tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -regular menstrual cycle 21-35 days lasting 3-7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis,&#xD;
             hyperthyroidism, active tuberculosis and psychosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>females</gender_description>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ghada Ebrahim El Refaye</investigator_full_name>
    <investigator_title>Clinical lecturer</investigator_title>
  </responsible_party>
  <keyword>Dysmenorrhea</keyword>
  <keyword>Pulsed electromagnetic field</keyword>
  <keyword>Diclofenac</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>three months</ipd_time_frame>
    <ipd_access_criteria>the protocol of study, for 3 months</ipd_access_criteria>
  </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/NCT03269591
org study id: dr ghada
nct id: NCT03269591
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled
      trial in the Egyptian women
Background: Primary dysmenorrhea is one of the most common complaints of women and is also
      the most common gynecological problem worldwide. These cramps are recurrent and 90%
      adolescent girls and about 50% women suffer from it. Purpose of the study: to determine which
      is more effective in alleviating primary dysmenorrhea; pulsed electromagnetic field or
      diclofenac drugs. Methodology: The study was a randomized, double-blinded trial, fifty adult
      females participated in this study, were divided randomly into two groups equal in numbers:
      group (A) received pulsed electromagnetic field applied on pelvic region, 3 times per week
      for 3 months, 20 minutes per day and group (B) received diclofenac tablets, 50 mg only with
      onset of menstrual pain. All participants in both groups (A and B) were assessed pre- and
      post-treatment through measuring progesterone level in the blood, assessment of pain using
      visual analogue scale and physical as well as psychological symptoms by using menstrual
      symptom questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: (Participant, Outcomes Assessor)
measure: Visual analogue scale
time frame: three months
description: was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month); in both groups (A and B) by (16), it is a graphic rating scale with numerical values placed equidistantly along the line. The descriptors and numbers help the subject to place her estimate on line in which (0) mean no pain, (1) equal mild pain, (2) equal moderate pain, (3) mean severe pain and (4) mean unbearable pain.
measure: Progesterone blood level
time frame: three months
description: Sample of blood was taken to detect the level of progesterone.
measure: Menstrual symptom questionnaire
time frame: three months
description: to assess symptoms of dysmenorrhea
arm group label: Pulsed electromagnetic field
arm group type: Active Comparator
description: magnetic therapy device which generate frequency from 5-100 Hz and intensity from 1 to 60 Gauss. Group (A) received 20 min 3 times per week for three month with strength 60 gauss and frequency 50 Hz
arm group label: diclofenac tablets
arm group type: Experimental
description: (50 mg) few hours at the onset of menstruation for 3 months
arm group label: Visual analogue scale
arm group type: Other
description: was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
arm group label: Progesterone blood level
arm group type: Other
description: Sample of blood was taken to detect the level of progesterone.
arm group label: Menstrual symptom questionnaire
arm group type: Other
description: to assess symptoms of dysmenorrhea.
intervention type: Device
intervention name: Pulsed electromagnetic field
description: EASY Qs portable (by ASA, Italy)
arm group label: Menstrual symptom questionnaire
arm group label: Progesterone blood level
arm group label: Pulsed electromagnetic field
arm group label: Visual analogue scale
arm group label: diclofenac tablets
intervention type: Drug
intervention name: diclofenac tablets
description: drugs
arm group label: Menstrual symptom questionnaire
arm group label: Progesterone blood level
arm group label: Pulsed electromagnetic field
arm group label: Visual analogue scale
arm group label: diclofenac tablets
intervention type: Diagnostic Test
intervention name: Visual analogue scale
description: a graphic rating scale
arm group label: Menstrual symptom questionnaire
arm group label: Progesterone blood level
arm group label: Pulsed electromagnetic field
arm group label: Visual analogue scale
arm group label: diclofenac tablets
intervention type: Diagnostic Test
intervention name: Progesterone blood level
description: blood test
arm group label: Menstrual symptom questionnaire
arm group label: Progesterone blood level
arm group label: Pulsed electromagnetic field
arm group label: Visual analogue scale
arm group label: diclofenac tablets
intervention type: Diagnostic Test
intervention name: Menstrual symptom questionnaire
description: questionnaire
arm group label: Menstrual symptom questionnaire
arm group label: Progesterone blood level
arm group label: Pulsed electromagnetic field
arm group label: Visual analogue scale
arm group label: diclofenac tablets
criteria: 
gender: Female
gender based: Yes
gender description: females
minimum age: 17 Years
maximum age: 24 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ghada Ebrahim El Refaye
investigator title: Clinical lecturer
mesh term: Dysmenorrhea
mesh term: Diclofenac
mesh term: Progesterone
sharing ipd: Yes
ipd description: Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women
ipd info type: Study Protocol
ipd time frame: three months
ipd access criteria: the protocol of study, for 3 months