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poSt Covid-19 Infection centraL Sensitisation 2 (SILENT 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04701892
Recruitment Status : Unknown
Verified January 2021 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : January 8, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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

Condition or disease Intervention/treatment
Covid19 Other: Indicators of central sensitisation

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Central Sensitisation in Post Covid-19 Infection Patients: a Prospective Cohort Study
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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 before inclusion in the study. More specifically, only patients who had a positive COVID-19 test 2 to 8 weeks before study inclusion are eligible.
 Other: Indicators of central sensitisation
Indicators of central sensitisation, assessed by the Central Sensitization Inventory


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms of Central Sensitisation [ Time Frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months ]
    Symptoms of central sensitisation will be measured with the Central Sensitization Inventory.


Secondary Outcome Measures :
  1. Pressure pain thresholds [ Time Frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months ]
    Pressure pain thresholds will be measured at the trapezius and rectus femoris muscles with an algometer.

  2. Temporal summation [ Time Frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months ]
    Temporal summation will be measured with 10 consecutive pressure pulses at the trapezius and rectus femoris muscles with an algometer.

  3. Descending nociceptive inhibition [ Time Frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months ]
    Descending nociceptive inhibition will be measured with a conditioned pain modulation protocol with algometer as test stimulus and the cold pressor task.

  4. Functionality and disability [ Time Frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months ]
    Functional status will be evaluated by the Post-COVID-19 Functional Status Scale.

  5. Functionality and disability [ Time Frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months ]
    Level of dyspnea during activities of daily living will be evaluated by the London chest Activity of Daily Living scale.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients who were previously infected with covid-19.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701892


Contacts
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Contact: Marc Schiltz, MD +32 2 477 60 20 marc.schiltz@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Jette, Brussel, Belgium, 1090
Contact: Marc Schiltz, MD    +32 2 477 60 20    marc.schiltz@uzbrussel.be   
Principal Investigator: Marc Schiltz         
Sub-Investigator: Ann De Smedt         
Sub-Investigator: Samar Hatem         
Sub-Investigator: Maarten Moens         
Sub-Investigator: Lisa Goudman         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
More Information
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04701892    
Other Study ID Numbers: SILENT 2
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases