Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit

Neuropathic Pain Clinical Trial

Official title:

Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit - a Multicenter Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940208
• Other study ID #: 2020-A02929-30
• Status: Completed
• Start date: January 11, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2022
• Source: Hôpital de la Croix-Rousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• COVID-19
• COVID-19 Pandemic
• ICU
• Neuralgia
• Neuropathic Pain
• Pain, Chronic
• Post Intensive Care Unit Syndrome

Intervention

Other:
• Pain and neuropsychological questionnaires
Patient-reported outcomes, listed in the Secondary Outcome Measure Section

Diagnostic Test:
• Quantitative Sensory testing
Summation pain threshold test and Heat pain threshold skin test

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Mikhail Dziadzko, MD, PhD	Bicetre Hospital, Hôpital Raymond Poincaré

Country where clinical trial is conducted

France, 

References & Publications (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. — View Citation

Carfì 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge
Secondary	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.	starting 6 month after discharge