Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit
NCT ID: NCT04940208
Last Updated: 2022-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
143 participants
OBSERVATIONAL
2021-01-11
2022-02-01
Brief Summary
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A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain.
A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients.
Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes.
The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care.
Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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post COVID-19 ICU survivors
Patients hospitalized to the ICU in the context of severe COVID-19 and discharged alive during the first French COVID-19 pandemic wave
Pain and neuropsychological questionnaires
Patient-reported outcomes, listed in the Secondary Outcome Measure Section
Quantitative Sensory testing
Summation pain threshold test and Heat pain threshold skin test
Interventions
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Pain and neuropsychological questionnaires
Patient-reported outcomes, listed in the Secondary Outcome Measure Section
Quantitative Sensory testing
Summation pain threshold test and Heat pain threshold skin test
Eligibility Criteria
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Inclusion Criteria
* hospitalized in the ICU for at least 48 hours
* with SARS-Cov2 infection confirmed by Polymerase Chain Reaction (PCR)/serology and/or a suggestive chest Computed Tomography scan
* during the first wave of COVID 19 from March to December 2020 at three investigator sites (2 in Paris and 1 in Lyon)
* discharged alive from the ICU
* at least 6 months after discharge
Exclusion Criteria
* inability to communicate or to have in-person appointment
* death in the period from ICU discharge to the first phone call for interview
18 Years
ALL
No
Sponsors
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Hôpital Raymond Poincaré
OTHER
Bicetre Hospital
OTHER
Mikhail Dziadzko, MD, PhD
OTHER
Responsible Party
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Mikhail Dziadzko, MD, PhD
Attending Pain Physician
Locations
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Hôpital Raymond Poincare - AP-HP
Garches, Hauts-de-Seine, France
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, , France
Hopital de la Croix Rousse - Hospices Civils de Lyon
Lyon, , France
Countries
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References
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Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.
Asadi-Pooya AA, Simani L. Central nervous system manifestations of COVID-19: A systematic review. J Neurol Sci. 2020 Jun 15;413:116832. doi: 10.1016/j.jns.2020.116832. Epub 2020 Apr 11.
Lee AM, Wong JG, McAlonan GM, Cheung V, Cheung C, Sham PC, Chu CM, Wong PC, Tsang KW, Chua SE. Stress and psychological distress among SARS survivors 1 year after the outbreak. Can J Psychiatry. 2007 Apr;52(4):233-40. doi: 10.1177/070674370705200405.
Martinez V, Dziadzko M, Tamayo J, Schitter S, Guichard L, Richeux F, Roggerone S, Branche P, Schlaefflin L, Nacto Y, Antunes T, Negre I, Annane D, Aubrun F. Chronic pain characteristics in COVID-19 survivors after an ICU stay. A cross-sectional study. Anaesth Crit Care Pain Med. 2023 Dec;42(6):101267. doi: 10.1016/j.accpm.2023.101267. Epub 2023 Jun 24.
Other Identifiers
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2020-A02929-30
Identifier Type: -
Identifier Source: org_study_id
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