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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04422522
Other study ID # AAGH-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 15, 2020
Est. completion date June 30, 2020

Study information

Verified date June 2020
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date June 30, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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).

Study Design


Locations

Country Name City State
Egypt Al-Azhar Faculty of medicine, Rheumatology Department Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of FM patients Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020) two months
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