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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04883216
Other study ID # 2021/389
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 24, 2021
Est. completion date December 31, 2021

Study information

Verified date April 2022
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 776
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University Istanbul Faculty of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 1 year
Primary 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. up to 1 year
Primary 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. up to 1 year
Primary Self-report Demographic Questionnaire A questionnaire made by the researchers to understand the demographic characteristics of the patients included. up to 1 year
Primary 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." up to 1 year
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