NCT04422522

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 7, 2020

Last Update Submit

June 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of FM patients

    Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020)

    two months

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients attending the rheumatology outpatients clinics (OPD) during the COVID-19 lockdown period (2020)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar Faculty of medicine, Rheumatology Department

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Ahmed Abogamal

    Al-Azhar Faculty of medicine- Cairo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 9, 2020

Study Start

March 15, 2020

Primary Completion

May 15, 2020

Study Completion

June 30, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations