Covid19NCT04883216
Investigation of the Characteristics of Chronic Pain Developing After COVID-19
An observational study of Covid19 and Coronavirus, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Coronavirus, Chronic Pain
- How many people
- 776 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2021to 31 Dec 2021
- How long will I take part?
- 1 Day
- 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: 1120 patients who had previously suffered from COVID-19 disease will be included in the study upon application to physical medicine and rehabilitation outpatient clinics with pain complaints developed after COVID-19.
Who may be able to join
- Being over the age of 18
- SARS-CoV-2 infection demonstrated with the PCR test (testing date irrelevant)
- Pain developed or increased after having COVID-19
Who cannot join
- 1. Mental retardation or mental status not eligible to answer the questionnaires
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34093
About this study
Official title: Investigation of the Characteristics of Chronic Pain Developing After COVID-19 in Patients With COVID-19
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.
Read the 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.
- Conditions
- Covid19, Coronavirus, Chronic Pain
- Keywords
- Chronic Pain, COVID19, Characteristics
- Medical subject headings
- COVID-19, Coronavirus Infections, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Leeds Assessment of Neuropathic Symptoms & Signs (S-LANSS) Pain Score
The S-LANSS aims to identify pain of predominantly neuropathic origin, as distinct from nociceptive pain, without the need for clinical examination.
Measured: up to 1 year
The Hospital Anxiety and Depression Scale (HADS) Score
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.
Measured: up to 1 year
Central Sensitization Inventory (CSI)
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.
Measured: up to 1 year
Self-report Demographic Questionnaire
A questionnaire made by the researchers to understand the demographic characteristics of the patients included.
Measured: up to 1 year
Visual Analog Scale (VAS) for Pain
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."
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start24 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 776 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Zure, Istanbul University
- Investigators
- Ayşegül Ketenci, Professor, Study director, ProfessorMert Zure, Expert, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883216
- Sponsor's protocol ID
- 2021/389
- Status last verified
- Apr 2022
- First submitted
- 9 May 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Weng LM, Su X, Wang XQ. Pain Symptoms in Patients with Coronavirus Disease (COVID-19): A Literature Review. J Pain Res. 2021 Jan 26;14:147-159. doi: 10.2147/JPR.S269206. eCollection 2021.
PubMed 33531833Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
PubMed 32112714Ding Y, He L, Zhang Q, Huang Z, Che X, Hou J, Wang H, Shen H, Qiu L, Li Z, Geng J, Cai J, Han H, Li X, Kang W, Weng D, Liang P, Jiang S. Organ distribution of severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV) in SARS patients: implications for pathogenesis and virus transmission pathways. J Pathol. 2004 Jun;203(2):622-30. doi: 10.1002/path.1560.
PubMed 15141376Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. doi: 10.1016/S1473-3099(05)70270-X.
PubMed 16253889
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Characteristics of Chronic Pain Developing After COVID-19 in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04883216
- Acronym / sponsor ID
- 2021/389
- Conditions
- Covid19, Coronavirus, Chronic Pain
- Keywords
- Chronic Pain, COVID19, Characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 May 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.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1120 patients who had previously suffered from COVID-19 disease will be included in the study upon application to physical medicine and rehabilitation outpatient clinics with pain complaints developed after COVID-19.
Key inclusion criteria (3 listed)
- Being over the age of 18
- SARS-CoV-2 infection demonstrated with the PCR test (testing date irrelevant)
- Pain developed or increased after having COVID-19
Key exclusion criteria (1 listed)
- 1. Mental retardation or mental status not eligible to answer the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-Leeds Assessment of Neuropathic Symptoms & Signs (S-LANSS) Pain Score
Time frame: 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.
The Hospital Anxiety and Depression Scale (HADS) Score
Time frame: 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.
Central Sensitization Inventory (CSI)
Time frame: 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.
Self-report Demographic Questionnaire
Time frame: up to 1 year
A questionnaire made by the researchers to understand the demographic characteristics of the patients included.
Visual Analog Scale (VAS) for Pain
Time frame: 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."
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 19 Apr 2022.
- Background: PubMed 33531833Weng LM, Su X, Wang XQ. Pain Symptoms in Patients with Coronavirus Disease (COVID-19): A Literature Review. J Pain Res. 2021 Jan 26;14:147-159. doi: 10.2147/JPR.S269206. eCollection 2021.
- Background: PubMed 32112714Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
- Background: PubMed 15141376Ding Y, He L, Zhang Q, Huang Z, Che X, Hou J, Wang H, Shen H, Qiu L, Li Z, Geng J, Cai J, Han H, Li X, Kang W, Weng D, Liang P, Jiang S. Organ distribution of severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV) in SARS patients: implications for pathogenesis and virus transmission pathways. J Pathol. 2004 Jun;203(2):622-30. doi: 10.1002/path.1560.
- Background: PubMed 16253889Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. doi: 10.1016/S1473-3099(05)70270-X.
- Individual participant dataSharing planned: Undecided
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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.
Ayşegül Ketenci, Professor study director
Professor
Mert Zure, Expert principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Coronavirus, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Self-Leeds Assessment of Neuropathic Symptoms & Signs (S-LANSS) Pain Score (time frame: up to 1 year). The study lists 5 primary outcomes in all. 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 NCT04883216, which also lists 4 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 19 Apr 2022.