NCT04883216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
776

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

May 9, 2021

Last Update Submit

April 18, 2022

Conditions

Keywords

Chronic PainCOVID19Characteristics

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • Self-report Demographic Questionnaire

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

    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."

    up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \. Mental retardation or mental status not eligible to answer the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 33531833BACKGROUND
  • 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.

    PMID: 32112714BACKGROUND
  • 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.

    PMID: 15141376BACKGROUND
  • 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.

    PMID: 16253889BACKGROUND

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsChronic Pain

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşegül Ketenci, Professor

    Professor

    STUDY DIRECTOR
  • Mert Zure, Expert

    MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 12, 2021

Study Start

March 24, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations