- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883216
Investigation of the Characteristics of Chronic Pain Developing After COVID-19
April 18, 2022 updated by: Mert Zure, Istanbul University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
776
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
-
-
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İstanbul, Turkey, 34093
- Istanbul University Istanbul Faculty of Medicine
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Mental retardation or mental status not eligible to answer the questionnaires
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to 1 year
|
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.
|
up to 1 year
|
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.
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up to 1 year
|
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.
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up to 1 year
|
Visual Analog Scale (VAS) for Pain
Time Frame: up to 1 year
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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."
|
up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ayşegül Ketenci, Professor, Professor
- Principal Investigator: Mert Zure, Expert, MD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brooks 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.
- Eccles 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.
- Ding 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.
- 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.
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)
March 24, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
May 9, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 18, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/389
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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