poSt Covid-19 Infection centraL sENsitisaTion (SILENT 1)

January 20, 2021 updated by: Universitair Ziekenhuis Brussel

Central Sensitisation in Post Covid-19 Infection Patients: a Cross-sectional Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussel
      • Jette, Brussel, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female patients who were previously infected with covid-19.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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 at least 6 months before inclusion in the study.
Other: Indicators of central sensitisation
Indicators of central sensitisation, assessed by the Central Sensitization Inventory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of Central Sensitisation
Time Frame: Once, at the moment of the study visit.
Symptoms of central sensitisation will be measured with the Central Sensitization Inventory.
Once, at the moment of the study visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain thresholds
Time Frame: Once, at the moment of the study visit.
Pressure pain thresholds will be measured at the trapezius and rectus femoris muscles with an algometer.
Once, at the moment of the study visit.
Temporal summation
Time Frame: Once, at the moment of the study visit.
Temporal summation will be measured with 10 consecutive pressure pulses at the trapezius and rectus femoris muscles with an algometer.
Once, at the moment of the study visit.
Descending nociceptive inhibition
Time Frame: Once, at the moment of the study visit.
Descending nociceptive inhibition will be measured with a conditioned pain modulation protocol with algometer as test stimulus and the cold pressor task.
Once, at the moment of the study visit.
Functionality and disability
Time Frame: Once, at the moment of the study visit.
Functional status will be evaluated by the Post-COVID-19 Functional Status Scale.
Once, at the moment of the study visit.
Functionality and disability
Time Frame: Once, at the moment of the study visit.
Level of dyspnea during activities of daily living will be evaluated by the London chest Activity of Daily Living scale.
Once, at the moment of the study visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SILENT 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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