Pain-related Long Covid in Covid-19 Survivors

August 8, 2023 updated by: Brian Duborg Ebbesen, Aalborg University
The exploratory project aims to investigate the presence of pain as a long Covid-19 symptom in previously hospitalised patients and in non-hospitalised persons previously tested positive in a PCR test.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The main objectives investigated will be to determine the general prevalence of pain symptoms In Covid-19 survivors, correlating and analysing the role of previously comorbidities in the development of pain symptom in Covid-19 survivors, and to understand the prevalence of pain related long Covid-19 symptoms for future characterisations. Hence, the projects main outcome will be to try to understand why som Covid-19 survivors develop persistant pain and others don't. Furthermore, the project plan to analyse gender and age differences, and data between Covid-19 waves as well as any possible association between pain prevalence and time after positive PCR-test.

Study Type

Observational

Enrollment (Estimated)

600000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • The North Denmark Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Hospital group: All patients aged 18 or above that has been admittet to a hospitals in Denmark between 1st of Mach 2020 and 31st of December 2021.

PCR+ group: All persons aged 18 or above that between 1st March 2020 and 31st of December 2021 have tested positive in a PCR test without hospital admission.

Description

Inclusion Criteria:

  • Previously infected with SARS-CoV-2 virus

Exclusion Criteria:

  • Participants under the age of 18
  • Hidden/secret address/name
  • No access to digital mail (the channel of data collection)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospitalization group
Previously hospitalized Covid-19 survivors who have been admittet to the hospital with or because of SARS-CoV-2 infection. Time from infection date start is > 6 months. The group is anticipated to encompass 2.182 privously hospitalized adult patients.
Other: Questionnaire and register-based data assessment
Primary data will be collected via a generic questionnaire from the two groups. Secondary data will consist of register-based socio-economic data and medical charts data collected from the Danish Health Data Authority and Denmark' Statistics.
PCR+ group
Non-hospitalized Covid-19 survivors that has previously testet positive in an Polymerase chain reaction test without being admittet to the hospital. Time from infection data start is > 6 months. The group will include almost the total population of adults who have tested positive in a Polymerase Chain Reaction test. Those with secret adresses and those without access to digital mail (information channel of the questionnaire) will be excluded being approcimatelyh 7% of 650.000 possible participants. The group encompasses 593.741 participants.
Other: Questionnaire and register-based data assessment
Primary data will be collected via a generic questionnaire from the two groups. Secondary data will consist of register-based socio-economic data and medical charts data collected from the Danish Health Data Authority and Denmark' Statistics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent pain in Covid-19 survivors
Time Frame: Above six months after a SARS-CoV-2 infection
Detection of possible differences in Covid-19 survivors with or without persistent pain after a SARS-CoV-2 infection as collected via questionnaire data
Above six months after a SARS-CoV-2 infection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of comorbidities in the development of persistent pain in Covid-19 survivors
Time Frame: Above six months after a SARS-CoV-2 infection
Register-based medical charts from hospitalization correlated with self-reported pain from the questionnaire data
Above six months after a SARS-CoV-2 infection
The role of comorbidities in the development of persistent pain in Covid-19 survivors II
Time Frame: Above six months after a SARS-CoV-2 infection
Register-based data about positive PCR-test correlated with self-reported pain from the questionnaire data
Above six months after a SARS-CoV-2 infection
The role of socio-economic impact on the development of persistent pain in Covid-19 survivors
Time Frame: Above six months after a SARS-CoV-2 infection
Register-based data of socio-economic variables that could influence self-rated perception of pain
Above six months after a SARS-CoV-2 infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Investigators

  • Study Director: Lars Arendt-Nielsen, Dr.med, PhD, The North Denmark Region
  • Principal Investigator: Brian D Ebbesen, PhD student, The North Denmark Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-056227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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