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poSt Covid-19 Infection centraL Sensitisation 2

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04701892
Acronym
SILENT 2
Enrollment
200
Registered
2021-01-08
Start date
2021-01-19
Completion date
2023-01-31
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

Indicators of central sensitisation, assessed by the Central Sensitization Inventory

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Symptoms of Central SensitisationThe change between baseline, 3 months, 6 months (primary time endpoint) and 12 monthsSymptoms of central sensitisation will be measured with the Central Sensitization Inventory.

Secondary

MeasureTime frameDescription
Pressure pain thresholdsThe change between baseline, 3 months, 6 months (primary time endpoint) and 12 monthsPressure pain thresholds will be measured at the trapezius and rectus femoris muscles with an algometer.
Temporal summationThe change between baseline, 3 months, 6 months (primary time endpoint) and 12 monthsTemporal summation will be measured with 10 consecutive pressure pulses at the trapezius and rectus femoris muscles with an algometer.
Descending nociceptive inhibitionThe change between baseline, 3 months, 6 months (primary time endpoint) and 12 monthsDescending nociceptive inhibition will be measured with a conditioned pain modulation protocol with algometer as test stimulus and the cold pressor task.
Functionality and disabilityThe change between baseline, 3 months, 6 months (primary time endpoint) and 12 monthsFunctional status will be evaluated by the Post-COVID-19 Functional Status Scale.

Countries

Belgium

Contacts

Primary ContactMarc Schiltz, MD
marc.schiltz@uzbrussel.be+32 2 477 60 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026