Clinical trial NCT04422522: Fibromyalgia During the COVID-19 Pandemic
Official title: Prevalence of Fibromyalgia in the Rheumatology Outpatient Clinics in the UAE During the COVID-19 Pandemic: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia, Primary
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending the rheumatology outpatients clinics (OPD) during the COVID-19 lockdown period (2020)

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.

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.

Eligibility 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).

Primary outcomes:
measure: Number of FM patients
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar Faculty of medicine, Rheumatology Department
Study officials:
affiliation: Al-Azhar Faculty of medicine- Cairo
name: Ahmed Abogamal
role: PRINCIPAL_INVESTIGATOR
References: