poSt Covid-19 Infection centraL sENsitisaTion

NCT ID: NCT04703452

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2022-01-31

Brief Summary

The aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

Detailed Description

The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.

The term central sensitivity syndrome (CSS) describes a group of medically nonspecific disorders, such as fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome, for which central sensitivity might be a common etiology. Despite the lack of a solid outcome measurement, the Central Sensitization Inventory (CSI) was previously introduced as a screening instrument for clinicians to help identify patients with a CSS. Furthermore, quantitative sensory testing can be used to identify and quantify sensory disfunctions by evaluating a variety of parameters including pain thresholds, temporal summation, and conditioned pain modulation (CPM). Previous research in patients with chronic pain resulted in less efficacious CPM, increased nociceptive facilitation and decreased pain thresholds.

In post covid-19 patients, potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms are a frequently reported complaint in patients recovered from COVID-19 infection with at least 1 symptom, particularly fatigue and dyspnea. Fatigue is also one of the core symptoms in central sensitisation disorders, leading to the hypothesis that central sensitisation might be the underlying common etiology in chronic pain patients and patients post COVID-19 infection. Therefore, the aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

Conditions

Covid19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Covid-19 infected patients

In this study male and female patients who were previously infected with covid-19 will be included. Patients will only be eligible if they had a positive covid-19 test at least 6 months before inclusion in the study.

Indicators of central sensitisation

Intervention Type: OTHER

Indicators of central sensitisation, assessed by the Central Sensitization Inventory

Interventions

Indicators of central sensitisation

Indicators of central sensitisation, assessed by the Central Sensitization Inventory

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosed covid-19 infection that took place at least 6 months before study inclusion.
• Cognitive and language functioning enabling coherent communication between the researcher and the participant.
• French-or Dutch speaking persons.

Exclusion Criteria

• Covid-19 infection < 6 months ago.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Marc Schiltz, MD

Role: CONTACT

marc.schiltz@uzbrussel.be

+32 2 477 60 20

Facility Contacts

Marc Schiltz, MD

Role: primary

marc.schiltz@uzbrussel.be

+32 2 477 60 20

Other Identifiers

SILENT 1

Identifier Type: -

Identifier Source: org_study_id