COVID-19 PandemicNCT04940208
Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit
An observational study of COVID-19 Pandemic and ICU, run by Mikhail Dziadzko, MD, PhD at 3 sites in France.
Trial summary
More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic, ICU, Pain, Chronic
- What is being tested?
- Pain and neuropsychological questionnaires and Quantitative Sensory testing
- How many people
- 143 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Jan 2021to 1 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: adult patients, infected with SARS COV2 and developed severe COVID, requiring hospitalisation to the ICU during the first French wave of COVID 19, with length of stay > 48 hours, survived and successfully discharged, and approached from 6th month post discharge.
Who may be able to join
- adults (>=18 y.o.)
- 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
Who cannot join
- patient refusal
- inability to communicate or to have in-person appointment
- death in the period from ICU discharge to the first phone call for interview
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Raymond Poincare - AP-HP
Garches, Hauts-de-Seine, 92380
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, Le Kremlin-Bicêtre
Hopital de la Croix Rousse - Hospices Civils de Lyon
Lyon, 69004
About this study
Official title: Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit - a Multicenter Observational Cohort Study
More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management.
A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain.
Read more
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.
- Conditions
- COVID-19 Pandemic, ICU, Pain, Chronic, Post Intensive Care Unit Syndrome, Neuropathic Pain
- Being tested
- Pain and neuropsychological questionnaires, Quantitative Sensory testing
- Keywords
- SARS-COV2, Intensive care unit, critical illness survivors, chronic pain, COVID long, Neuropathic pain, Quantitative Sensory testing
- Medical subject headings
- COVID-19, Chronic Pain, Neuralgia, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain and neuropsychological questionnairesOther
Patient-reported outcomes, listed in the Secondary Outcome Measure Section
Quantitative Sensory testingDiagnostic test
Summation pain threshold test and Heat pain threshold skin test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pain and neuropsychological questionnaires; Diagnostic Test: Quantitative Sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of secondary chronic pain
Secondary chronic pain as defined by International Classification of Disease -11th revision (ICD-11).
Chronic secondary pain is organized into the following six categories:
- Chronic cancer-related pain (ICD-11 code MG30.1)
- Chronic postsurgical or post-traumatic pain (ICD-11 code MG30.2)
- Chronic secondary musculoskeletal pain (ICD-11 code MG30.3)
- Chronic secondary visceral pain (ICD-11 code MG30.4)
- Chronic neuropathic pain (ICD-11 code MG30.5)
- Chronic secondary headache or orofacial pain (ICD-11 code MG30.6)
Any pain detected in the population of interest and fitting in one of 6 categories will be accounted.
Measured: starting 6 month after discharge
Secondary outcomes (12)
Frequency of different secondary chronic pain classes
as defined by ICD-11 and the International Association for the Study of Pain (IASP)
Chronic secondary pain is organized into the following six categories:
- Chronic cancer-related pain (ICD-11 code MG30.1)
- Chronic postsurgical or post-traumatic pain (ICD-11 code MG30.2)
- Chronic secondary musculoskeletal pain (ICD-11 code MG30.3)
- Chronic secondary visceral pain (ICD-11 code MG30.4)
- Chronic neuropathic pain (ICD-11 code MG30.5)
- Chronic secondary headache or orofacial pain (ICD-11 code MG30.6)
For each category of detected pain the frequency will be reported.
Measured: starting 6 month after discharge
Pain sensitivity level
Pain sensitivity level is tested with a Pain sensitivity questionnaire (PSQ). PSQ contains 17 items assessing pain with 11 level scoring from 0 (not at all painful) to 10 (most severe pain imaginable). Maximal summation score is 170, higher score mean worse outcome.
Measured: starting 6 month after discharge
Pain localization
A Michigan Body Map will be used for pain localization inventory. A Michigan Body Map is a self-report measure to assess body areas where chronic pain is experienced.
Measured: starting 6 month after discharge
The severity of pain and its impact on functioning
A Brief Pain Inventory (BPI) will be used to assess the severity of pain and its impact on functioning. The BPI pain scales defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. BPI Interference Items use 0 (less) to 10 (worth) scoring, the arithmetic mean of the interference items is used as a measure of pain interference, higher score mean worse outcome.
Measured: starting 6 month after discharge
Neuropathic pain
A DN4 scale will be used to detect a neuropathic pain. The DN4 (which stands for Douleur Neuropathique 4) is a clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. Each item has binary value (yes/no), maximal summation score is 10, and the threshold for neuropathic pain is 4.
Measured: starting 6 month after discharge
Spiegel Sleep Quality Questionnaire
Spiegel Sleep Questionnaire is a self-rated questionnaire which assesses the current sleep quality and disturbances. It has six 5 point Likert-like items rated from worst to best value. The total summation score is 30, less score values indicates worth outcome. The threshold of bad sleep is less than 15, and the score 20 indicates a good sleep.
Measured: starting 6 month after discharge
Posttraumatic Stress Disorder
Posttraumatic Stress Disorder Checklist Scale is a 20-item self-report measure that assesses the symptoms of Posttraumatic Stress Disorder. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month.
A total symptom severity score is obtained by summing the scores for each of the 20 items. The score superior of 31 is indicative of probable Posttraumatic Stress Disorder.
Measured: starting 6 month after discharge
Anxiety and Depression
Hospital Anxiety Depression scale will be used, it measures anxiety and depression in a general medical population of patients. The questionnaire comprises seven questions for anxiety and seven questions for depression. Greater score values indicates worth outcome.
For both scales, scores of less than 7 indicate non-cases; 8-10 - mild depression or anxiety; 11-14 - moderate depression or anxiety; and 15-21 - severe depression or anxiety.
Measured: starting 6 month after discharge
Pain Catastrophizing Level
Pain Catastrophizing Scale quantifies an individual's pain experience. It has 13 items rated on 5-point Likert-like scales (0 - not at all to 4 - all the time). A total score is yielded (ranging from 0-52), the threshold above 30 is considered clinically relevant. Higher score indicates higher level of catastrophizing and bad outcome.
Measured: starting 6 month after discharge
Perceived Stress Level
Perceived Stress Scale (PSS-10) is a self stress assessment instrument. It has 10 items rated on 5-point Likert-like scales (0 - never to 4 - very often). Individual scores on the PSS-10 can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: starting 6 month after discharge
Summation pain threshold
Mechanical temporal summation will be evoked using methodology described by Weissman-Fogel, 2008, by Von Frey Filaments, using a 180-gr filament that will be applied to the volar aspect of the dominant forearm. Patients will be exposed to a single stimulus and will be asked to rate the level of pinprick pain intensity using 11 items numeric pain scale. This pain score serve as an index for mechanical suprathreshold pain. Subsequently, 1 Hz repetitive stimuli will be applied within an area of 1 cm in diameter, using the same filament, and subjects will be asked to rate the pain intensity of the last stimulus. The magnitude of mechanical temporal summation will be calculated as the difference between the last and the first pain scores. Higher values indicates worth outcome.
Measured: starting 6 month after discharge
Heat pain threshold
A heat pain threshold will be realized using Thermal Stimulator for Sensory testing (SOMEDIC(R)). A thermode (heating stick) of 7 square centimeters will be applied to the volar aspect of the dominant forearm. Patients will be exposed to 3 repetitive gradual increase in temperature from 32° to 52°C. The skin contact will be withdrawn if an individual is not able to tolerate such stimulation, and the temperature threshold of tolerance will be noted. The final reading will be the median of three measurements, higher values indicate better tolerance.
Measured: starting 6 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start11 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikhail Dziadzko, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Raymond Poincaré, Bicetre Hospital
- Responsible party
- Sponsor-investigator, Mikhail Dziadzko, MD, PhD, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940208
- Sponsor's protocol ID
- 2020-A02929-30
- Status last verified
- Feb 2022
- First submitted
- 21 Jun 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data are the property of investigator's centers and will not be shared
Publications
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.
PubMed 32644129Needham 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.
PubMed 32346843Asadi-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.
PubMed 32299017Lee 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.
PubMed 17500304Martinez 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.
PubMed 37356618
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit - a Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04940208
- Acronym / sponsor ID
- 2020-A02929-30
- Conditions
- COVID-19 Pandemic, ICU, Pain, Chronic, Post Intensive Care Unit Syndrome, Neuropathic Pain
- Keywords
- SARS-COV2, Intensive care unit, critical illness survivors, chronic pain, COVID long, Neuropathic pain, Quantitative Sensory testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Mikhail Dziadzko, MD, PhDUniversity, hospital or other
- Collaborators
- Hôpital Raymond Poincaré, Bicetre Hospital
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 25 Jun 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.
More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post COVID-19 ICU survivors | – | Other: Pain and neuropsychological questionnaires, Diagnostic Test: Quantitative Sensory testingPatients hospitalized to the ICU in the context of severe COVID-19 and discharged alive during the first French COVID-19 pandemic wave |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients, infected with SARS COV2 and developed severe COVID, requiring hospitalisation to the ICU during the first French wave of COVID 19, with length of stay > 48 hours, survived and successfully discharged, and approached from 6th month post discharge.
Key inclusion criteria (6 listed)
- adults (>=18 y.o.)
- 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
Key exclusion criteria (3 listed)
- patient refusal
- inability to communicate or to have in-person appointment
- death in the period from ICU discharge to the first phone call for interview
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 |
|---|---|---|
| Pain and neuropsychological questionnairesPatient-reported outcomes, listed in the Secondary Outcome Measure Section | Other | post COVID-19 ICU survivors |
| Quantitative Sensory testingSummation pain threshold test and Heat pain threshold skin test | Diagnostic test | post COVID-19 ICU survivors |
Primary outcome
Incidence of secondary chronic pain
Time frame: starting 6 month after discharge
Secondary chronic pain as defined by International Classification of Disease -11th revision (ICD-11). Chronic secondary pain is organized into the following six categories: 1. Chronic cancer-related pain (ICD-11 code MG30.1) 2. Chronic postsurgical or post-traumatic pain (ICD-11 code MG30.2) 3. Chronic secondary musculoskeletal pain (ICD-11 code MG30.3) 4. Chronic secondary visceral pain (ICD-11 code MG30.4) 5. Chronic neuropathic pain (ICD-11 code MG30.5) 6. Chronic secondary headache or orofacial pain (ICD-11 code MG30.6) Any pain detected in the population of interest and fitting in one of 6 categories will be accounted.
12 secondary outcomes
Frequency of different secondary chronic pain classes
Time frame: starting 6 month after discharge
Pain sensitivity level
Time frame: starting 6 month after discharge
Pain localization
Time frame: starting 6 month after discharge
The severity of pain and its impact on functioning
Time frame: starting 6 month after discharge
Neuropathic pain
Time frame: starting 6 month after discharge
Spiegel Sleep Quality Questionnaire
Time frame: starting 6 month after discharge
Posttraumatic Stress Disorder
Time frame: starting 6 month after discharge
Anxiety and Depression
Time frame: starting 6 month after discharge
Pain Catastrophizing Level
Time frame: starting 6 month after discharge
Perceived Stress Level
Time frame: starting 6 month after discharge
Summation pain threshold
Time frame: starting 6 month after discharge
Heat pain threshold
Time frame: starting 6 month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Background: PubMed 32644129Carfi 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.
- Background: PubMed 32346843Needham 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.
- Background: PubMed 32299017Asadi-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.
- Background: PubMed 17500304Lee 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.
- Derived from this study: PubMed 37356618Martinez 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.
- Individual participant dataSharing planned: No. individual participant data are the property of investigator's centers and will not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and ICU, run by Mikhail Dziadzko, MD, PhD at 3 sites in France.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of secondary chronic pain (time frame: starting 6 month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940208, which also lists 5 linked publications.
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 2 Feb 2022.