poSt Covid-19 Infection centraL Sensitisation 2

• Conditions: Covid19
• Interventions: Other: Indicators of central sensitisation

• Registration Number: NCT04701892
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-01-19
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid-19 infected patients	Indicators of central sensitisation	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.

Primary Outcome Measures

Name	Time	Method
Symptoms of Central Sensitisation	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

Name	Time	Method
Descending nociceptive inhibition	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.
Pressure pain thresholds	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.
Temporal summation	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.
Functionality and disability	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.

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussel, Belgium