poSt Covid-19 Infection centraL Sensitisation 2

Covid19 Clinical Trial

— SILENT 2  

Official title:

Central Sensitisation in Post Covid-19 Infection Patients: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701892
• Other study ID #: SILENT 2
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: January 2023

Study information

• Verified date: January 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: Marc Schiltz, MD
• Phone: +32 2 477 60 20
• Email: marc.schiltz[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosed covid-19 infection that took place 2-8 weeks 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 > 8 weeks ago.

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Other:
• Indicators of central sensitisation
Indicators of central sensitisation, assessed by the Central Sensitization Inventory

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Central Sensitisation	Symptoms of central sensitisation will be measured with the Central Sensitization Inventory.	The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Secondary	Pressure pain thresholds	Pressure pain thresholds will be measured at the trapezius and rectus femoris muscles with an algometer.	The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Secondary	Temporal summation	Temporal summation will be measured with 10 consecutive pressure pulses at the trapezius and rectus femoris muscles with an algometer.	The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Secondary	Descending nociceptive inhibition	Descending nociceptive inhibition will be measured with a conditioned pain modulation protocol with algometer as test stimulus and the cold pressor task.	The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Secondary	Functionality and disability	Functional status will be evaluated by the Post-COVID-19 Functional Status Scale.	The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Secondary	Functionality and disability	Level of dyspnea during activities of daily living will be evaluated by the London chest Activity of Daily Living scale.	The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months