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Fibromyalgia During the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422522
Recruitment Status : Active, not recruiting
First Posted : June 9, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Abogamal, Al-Azhar University

Brief Summary:

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.


Condition or disease
Fibromyalgia, Primary

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prevalence of Fibromyalgia in the Rheumatology Outpatient Clinics in the UAE During the COVID-19 Pandemic: a Cross-sectional Study
Actual Study Start Date : March 15, 2020
Actual Primary Completion Date : May 15, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia




Primary Outcome Measures :
  1. Number of FM patients [ Time Frame: two months ]
    Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients attending the rheumatology outpatients clinics (OPD) during the COVID-19 lockdown period (2020)
Criteria

Inclusion Criteria:

  • Patients aged > 18 year
  • Diagnosis of primary fibromyalgia
  • Newly diagnosed and follow up patients are included
  • Patients who have physically attended the rheumatology clinic during the study period.

Exclusion Criteria:

  • Patients aged < 18-year-old
  • Patients with inflammatory arthritis and associated FM (Secondary FM)
  • Patients who didn't physically attend the rheumatology clinics (Those who used Phone calls and other telemedicine platforms).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422522


Locations
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Egypt
Al-Azhar Faculty of medicine, Rheumatology Department
Cairo, Egypt, 11311
Sponsors and Collaborators
Al-Azhar University
Investigators
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Principal Investigator: Ahmed Abogamal Al-Azhar Faculty of medicine- Cairo
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Responsible Party: Ahmed Abogamal, Professor, Al-Azhar University
ClinicalTrials.gov Identifier: NCT04422522    
Other Study ID Numbers: AAGH-01
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases