<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/NCT04422522</url>
  </required_header>
  <id_info>
    <org_study_id>AAGH-01</org_study_id>
    <nct_id>NCT04422522</nct_id>
  </id_info>
  <brief_title>Fibromyalgia During the COVID-19 Pandemic</brief_title>
  <official_title>Prevalence of Fibromyalgia in the Rheumatology Outpatient Clinics in the UAE During the COVID-19 Pandemic: a Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar 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>
      On 12 January 2020, the World Health Organization (WHO) confirmed that a novel coronavirus&#xD;
      was the cause of a respiratory illness in a cluster of people in Wuhan City, Hubei Province,&#xD;
      China, which was reported to the WHO on 31 December 2019.&#xD;
&#xD;
      There is evidence of a high prevalence of psychiatric comorbidities in Fibromyalgia (FM&#xD;
      )(especially depression, anxiety, post-traumatic stress disorder), which are associated with&#xD;
      a worse clinical profile.&#xD;
&#xD;
      In these challenging times of COVID-19, anxiety increased among the general population.&#xD;
      Fibromyalgia patients are more at risk of developing anxiety in these difficult times. This&#xD;
      might result in more frequent visits to the rheumatology clinics with an exacerbation of&#xD;
      their chronic pain syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first confirmed case relating to the COVID-19 pandemic in the United Arab Emirates was&#xD;
      announced on 29 January 2020.&#xD;
&#xD;
      On March 11, the World Health Organization (WHO) declared the global outbreak a pandemic.&#xD;
      Many measures have been taken by the UAE government since the COVID-19 outbreak started&#xD;
      hitting the region. From Mid March, the UAE had advised all citizens to restrict themselves&#xD;
      to essential travel only and had implemented a curfew between 8 pm and 6 am every day&#xD;
      starting from the end of March. On April 5th, UAE imposed a two-week lockdown to contain the&#xD;
      COVID-19 pandemic and announced there will be disinfection drives.&#xD;
&#xD;
      Many awareness campaigns were initiated by rheumatologists through different media channels&#xD;
      advising patients with rheumatic diseases to avoid clinics and hospitals unless they have an&#xD;
      emergency. Some healthcare facilities started telemedicine services including rheumatology&#xD;
      outpatient clinics. However, most of the clinics and hospitals have maintained open&#xD;
      rheumatology clinics aiming to manage emergency cases.&#xD;
&#xD;
      Fibromyalgia (FM) is a chronic disorder characterized by widespread and chronic&#xD;
      musculoskeletal pain and other frequent syndromes such as chronic fatigue sleep disturbance,&#xD;
      cognitive impairment, irritable bowel disease, depression, and anxiety.&#xD;
&#xD;
      There is evidence of a high prevalence of psychiatric comorbidities in FM (especially&#xD;
      depression, anxiety, post-traumatic stress disorder), which are associated with a worse&#xD;
      clinical profile.&#xD;
&#xD;
      In these challenging times of COVID-19, anxiety increased among the general population.&#xD;
      Fibromyalgia patients are more at risk of developing anxiety in these difficult times. This&#xD;
      might result in more frequent visits to the rheumatology clinics with an exacerbation of&#xD;
      their chronic pain syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of FM patients</measure>
    <time_frame>two months</time_frame>
    <description>Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020)</description>
  </primary_outcome>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Fibromyalgia, Primary</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attending the rheumatology outpatients clinics (OPD) during the COVID-19 lockdown&#xD;
        period (2020)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt; 18 year&#xD;
&#xD;
          -  Diagnosis of primary fibromyalgia&#xD;
&#xD;
          -  Newly diagnosed and follow up patients are included&#xD;
&#xD;
          -  Patients who have physically attended the rheumatology clinic during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged &lt; 18-year-old&#xD;
&#xD;
          -  Patients with inflammatory arthritis and associated FM (Secondary FM)&#xD;
&#xD;
          -  Patients who didn't physically attend the rheumatology clinics (Those who used Phone&#xD;
             calls and other telemedicine platforms).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Abogamal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Al-Azhar Faculty of medicine- Cairo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Al-Azhar Faculty of medicine, Rheumatology Department</name>
      <address>
        <city>Cairo</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Ahmed Abogamal</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04422522
org study id: AAGH-01
nct id: NCT04422522
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
On 12 January 2020, the World Health Organization (WHO) confirmed that a novel coronavirus
      was the cause of a respiratory illness in a cluster of people in Wuhan City, Hubei Province,
      China, which was reported to the WHO on 31 December 2019.

      There is evidence of a high prevalence of psychiatric comorbidities in Fibromyalgia (FM
      )(especially depression, anxiety, post-traumatic stress disorder), which are associated with
      a worse clinical profile.

      In these challenging times of COVID-19, anxiety increased among the general population.
      Fibromyalgia patients are more at risk of developing anxiety in these difficult times. This
      might result in more frequent visits to the rheumatology clinics with an exacerbation of
      their chronic pain syndrome.
The first confirmed case relating to the COVID-19 pandemic in the United Arab Emirates was
      announced on 29 January 2020.

      On March 11, the World Health Organization (WHO) declared the global outbreak a pandemic.
      Many measures have been taken by the UAE government since the COVID-19 outbreak started
      hitting the region. From Mid March, the UAE had advised all citizens to restrict themselves
      to essential travel only and had implemented a curfew between 8 pm and 6 am every day
      starting from the end of March. On April 5th, UAE imposed a two-week lockdown to contain the
      COVID-19 pandemic and announced there will be disinfection drives.

      Many awareness campaigns were initiated by rheumatologists through different media channels
      advising patients with rheumatic diseases to avoid clinics and hospitals unless they have an
      emergency. Some healthcare facilities started telemedicine services including rheumatology
      outpatient clinics. However, most of the clinics and hospitals have maintained open
      rheumatology clinics aiming to manage emergency cases.

      Fibromyalgia (FM) is a chronic disorder characterized by widespread and chronic
      musculoskeletal pain and other frequent syndromes such as chronic fatigue sleep disturbance,
      cognitive impairment, irritable bowel disease, depression, and anxiety.

      There is evidence of a high prevalence of psychiatric comorbidities in FM (especially
      depression, anxiety, post-traumatic stress disorder), which are associated with a worse
      clinical profile.

      In these challenging times of COVID-19, anxiety increased among the general population.
      Fibromyalgia patients are more at risk of developing anxiety in these difficult times. This
      might result in more frequent visits to the rheumatology clinics with an exacerbation of
      their chronic pain syndrome.
observational model: Case-Only
time perspective: Retrospective
measure: Number of FM patients
time frame: two months
description: Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Abogamal
role: Principal Investigator
affiliation: Al-Azhar Faculty of medicine- Cairo
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Ahmed Abogamal
investigator title: Professor
mesh term: COVID-19
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: Undecided