Investigation of the Characteristics of Chronic Pain Developing After COVID-19

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT04883216
Collaborator
(none)
776
1
9.3
83.8

Study Details

Study Description

Brief Summary

Data on pain after COVID-19 were generally collected from hospitalized patients and only include information on acute pain conditions. However, the characteristics of the chronic pain experienced after COVID-19 are unknown. For this reason, the treatment and recommendations for patients who present with chronic pain after COVID-19 are not clear. Our goal is to determine the characteristics and risk factors of chronic pain developing in COVID-19 patients and to create specific treatment recommendations for these patient groups with further studies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Data on pain developing after COVID-19 were generally collected from hospitalized patients and only include information on acute pain conditions seen after the ilness. It is noteworthy that headache and musculoskeletal pain were seen common in first few weeks. However, the characteristics (mechanical, inflammatory, central sensitization, anxiety-related, etc.) of the chronic pain experienced are unknown. For this reason, the treatment and recommendations for patients who present with chronic pain after COVID-19 are not clear. Our goal is to determine the characteristics and risk factors of chronic pain developing in COVID-19 patients and to create specific treatment recommendations for these patient groups with further studies.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    776 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Investigation of the Characteristics of Chronic Pain Developing After COVID-19 in Patients With COVID-19
    Actual Study Start Date :
    Mar 24, 2021
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Self-Leeds Assessment of Neuropathic Symptoms & Signs (S-LANSS) Pain Score [up to 1 year]

      The S-LANSS aims to identify pain of predominantly neuropathic origin, as distinct from nociceptive pain, without the need for clinical examination.

    2. The Hospital Anxiety and Depression Scale (HADS) Score [up to 1 year]

      The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that has been found to be a reliable instrument for detecting states of anxiety and depression in the setting of hospital outpatient clinic. The HADS questionnaire has seven items each for depression and anxiety subscales.

    3. Central Sensitization Inventory (CSI) [up to 1 year]

      The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS) or central sensitivity syndromes (CSS) such as fibromyalgia, neck injury, temporomandibular joint disorder or migraine/tension headaches. CSI includes 25 questions related to common CSS symptoms.

    4. Self-report Demographic Questionnaire [up to 1 year]

      A questionnaire made by the researchers to understand the demographic characteristics of the patients included.

    5. Visual Analog Scale (VAS) for Pain [up to 1 year]

      The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Being over the age of 18

    2. SARS-CoV-2 infection demonstrated with the PCR test (testing date irrelevant)

    3. Pain developed or increased after having COVID-19

    Exclusion Criteria:
    1. Mental retardation or mental status not eligible to answer the questionnaires

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Istanbul Faculty of Medicine İstanbul Turkey 34093

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Study Director: Ayşegül Ketenci, Professor, Professor
    • Principal Investigator: Mert Zure, Expert, MD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mert Zure, Medical Doctor, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT04883216
    Other Study ID Numbers:
    • 2021/389
    First Posted:
    May 12, 2021
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mert Zure, Medical Doctor, Istanbul University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2022