Fibromyalgia, PrimaryNCT04422522
Fibromyalgia During the COVID-19 Pandemic
An observational study of Fibromyalgia, Primary, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Fibromyalgia, Primary
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending the rheumatology outpatients clinics (OPD) during the COVID-19 lockdown period (2020)
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Fibromyalgia in the Rheumatology Outpatient Clinics in the UAE During the COVID-19 Pandemic: a Cross-sectional Study
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.
Read the 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.
- Conditions
- Fibromyalgia, Primary
- Medical subject headings
- Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of FM patients
Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020)
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Mar 2020
- Primary completion15 May 2020
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abogamal, Al-Azhar University
- Investigators
- Ahmed Abogamal, Principal investigator, Al-Azhar Faculty of medicine- Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422522
- Sponsor's protocol ID
- AAGH-01
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Fibromyalgia in the Rheumatology Outpatient Clinics in the UAE During the COVID-19 Pandemic: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04422522
- Acronym / sponsor ID
- AAGH-01
- Conditions
- Fibromyalgia, Primary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the rheumatology outpatients clinics (OPD) during the COVID-19 lockdown period (2020)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of FM patients
Time frame: two months
Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Abogamal principal investigator
Al-Azhar Faculty of medicine- Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, Primary, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of FM patients (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.