Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04940208
Other study ID # 2020-A02929-30
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04699734 - Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Completed NCT05235191 - Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies Phase 3
Completed NCT05845177 - Persistent Pain After Hip Replacement
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Not yet recruiting NCT05949554 - Electroencephalographic (EEG) Profils for Patients on Intravenous Ketamine.
Withdrawn NCT05052645 - Ear Acupuncture for Neuropathic Pain N/A
Completed NCT02866396 - Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
Completed NCT02824588 - Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain N/A
Completed NCT02930551 - Neuromas as the Cause of Pain N/A
Active, not recruiting NCT02560545 - Cannabinoids Effects on the Pain Modulation System N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Completed NCT02099890 - The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury Phase 3
Not yet recruiting NCT02246517 - The Effect of N2O on Chronic Neuropathic Pain Patients Phase 0
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Completed NCT01718821 - Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients N/A
Completed NCT01669967 - The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin N/A
Completed NCT01207596 - Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain Phase 4
Completed NCT01201317 - A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy Phase 2