Clinical trial NCT04701892: poSt Covid-19 Infection centraL Sensitisation 2
Official title: Central Sensitisation in Post Covid-19 Infection Patients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients who were previously infected with covid-19.

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.

Eligibility 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.

Primary outcomes:
measure: Symptoms of Central Sensitisation
timeFrame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Secondary outcomes:
measure: Pressure pain thresholds
timeFrame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
measure: Temporal summation
timeFrame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
measure: Descending nociceptive inhibition
timeFrame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
measure: Functionality and disability
timeFrame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
measure: Functionality and disability
timeFrame: The change between baseline, 3 months, 6 months (primary time endpoint) and 12 months
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
References: