Covid19SILENT 2NCT04701892
poSt Covid-19 Infection centraL Sensitisation 2
An observational study of Covid19, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Indicators of central sensitisation
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jan 2021to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Male and female patients who were previously infected with covid-19.
Who may be able to join
- 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.
Who cannot join
- Covid-19 infection > 8 weeks ago.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Marc Schiltz, MD, +32 2 477 60 20, marc.schiltz@uzbrussel.be
Marc Schiltz
About this study
Official title: Central Sensitisation in Post Covid-19 Infection Patients: a Prospective Cohort Study
The aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.
Read the 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
- Being tested
- Indicators of central sensitisation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indicators of central sensitisationOther
Indicators of central sensitisation, assessed by the Central Sensitization Inventory
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Indicators of central sensitisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of Central Sensitisation
Symptoms of central sensitisation will be measured with the Central Sensitization Inventory.
Measured: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Secondary outcomes (5)
Pressure pain thresholds
Pressure pain thresholds will be measured at the trapezius and rectus femoris muscles with an algometer.
Measured: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Temporal summation
Temporal summation will be measured with 10 consecutive pressure pulses at the trapezius and rectus femoris muscles with an algometer.
Measured: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
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.
Measured: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Functionality and disability
Functional status will be evaluated by the Post-COVID-19 Functional Status Scale.
Measured: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Functionality and disability
Level of dyspnea during activities of daily living will be evaluated by the London chest Activity of Daily Living scale.
Measured: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start19 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701892
- Sponsor's protocol ID
- SILENT 2
- Acronym
- SILENT 2
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sensitisation in Post Covid-19 Infection Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04701892
- Acronym / sponsor ID
- SILENT 2 / SILENT 2
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 infected patients | – | Other: Indicators of central sensitisationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who were previously infected with covid-19.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Covid-19 infection > 8 weeks ago.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indicators of central sensitisationIndicators of central sensitisation, assessed by the Central Sensitization Inventory | Other | Covid-19 infected patients |
Primary outcome
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.
5 secondary outcomes
Pressure pain thresholds
Time frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Temporal summation
Time frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Descending nociceptive inhibition
Time frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Functionality and disability
Time frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Functionality and disability
Time frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Schiltz, MD (+32 2 477 60 20, marc.schiltz@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of Central Sensitisation (time frame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.