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出境医 / 临床实验 / Musculoskeletal Symptoms in Post Acute Covid-19 Patients

Musculoskeletal Symptoms in Post Acute Covid-19 Patients

Study Description
Brief Summary:
The patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared with the patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory, chest computed tomography findings.

Condition or disease Intervention/treatment
Covid19 Musculoskeletal Abnormalities Other: Survey Other: Laboratory parameters Other: chest computed tomography

Detailed Description:

There is a lack of an overview of the factors associated with post acute-Covid-19 musculoskeletal symptoms. The aims are;1-to evaluate the most frequent admission symptoms and the frequency of musculoskeletal symptoms in post acute-Covid-19 patients,2-to determine the related factors with the post acute-Covid-19 musculoskeletal symptoms.

In this retrospective study; the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared wthe patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory (complete blood count, C-reactive protein, ferritin, D-dimer), chest computed tomography findings.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 280 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Musculoskeletal Symptoms and Related Factors in Post Acute Covid-19 Patients
Actual Study Start Date : June 11, 2021
Actual Primary Completion Date : June 13, 2021
Actual Study Completion Date : June 14, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Change
the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19 (n=240)
Other: Survey
A detailed anamnesis was retrospectively recorded about age, gender, body mass index, education, working, the presence of any chronic disease (diabetes mellitus, hypertension, chronic obstructive pulmonary disease, cardiac disease, cancer, rheumatological disease…), smoking, duration of symptoms, usage of supplementing vitamins such as vitamin D,C, zinc…, treatment place (home quarantine, hospital, intensive care unit), duration of home quarantine and hospital treatment, the number of months since the onset of Covid-19 symptoms, usage of anticoagulants, treatment drugs such as hydroxychloroquine, favipiravir. Also the symptoms during the period of Covid-19 infection were recorded from patient files; cough, fever, dyspnea, chest pain, loss of smell and taste, sore throat, headache, no symptom, musculoskeletal symptoms such as: muscle, low back, back, joint pain.

Other: Laboratory parameters
The laboratory values of 182 patients, presence of chest computed tomography findings of 206 patients and symptoms of all patients during the period of Covid-19 infection, were retrospectively recorded. Laboratory values of hemoglobin, leucocyte, lymphocyte, platelet, C-reactive protein, erythrocyte sedimentation rate, ferritin, d-dimer, were recorded.

Other: chest computed tomography
Typical findings of chest CT were; bilateral, multifocal, peripheral ground glass opacities with/without consolidation, including the fissures, close to visceral pleural surfaces. Covid-19 Reporting and Data System (CO-RADS) was used for chest CT. CO-RADS assigns scores from 1 (very low suspicion of Covid-19) to 5 (very high suspicion of Covid-19).

No change
the patients whose musculoskeletal symptoms did not change with Covid-19 (n=40)
Other: Survey
A detailed anamnesis was retrospectively recorded about age, gender, body mass index, education, working, the presence of any chronic disease (diabetes mellitus, hypertension, chronic obstructive pulmonary disease, cardiac disease, cancer, rheumatological disease…), smoking, duration of symptoms, usage of supplementing vitamins such as vitamin D,C, zinc…, treatment place (home quarantine, hospital, intensive care unit), duration of home quarantine and hospital treatment, the number of months since the onset of Covid-19 symptoms, usage of anticoagulants, treatment drugs such as hydroxychloroquine, favipiravir. Also the symptoms during the period of Covid-19 infection were recorded from patient files; cough, fever, dyspnea, chest pain, loss of smell and taste, sore throat, headache, no symptom, musculoskeletal symptoms such as: muscle, low back, back, joint pain.

Other: Laboratory parameters
The laboratory values of 182 patients, presence of chest computed tomography findings of 206 patients and symptoms of all patients during the period of Covid-19 infection, were retrospectively recorded. Laboratory values of hemoglobin, leucocyte, lymphocyte, platelet, C-reactive protein, erythrocyte sedimentation rate, ferritin, d-dimer, were recorded.

Other: chest computed tomography
Typical findings of chest CT were; bilateral, multifocal, peripheral ground glass opacities with/without consolidation, including the fissures, close to visceral pleural surfaces. Covid-19 Reporting and Data System (CO-RADS) was used for chest CT. CO-RADS assigns scores from 1 (very low suspicion of Covid-19) to 5 (very high suspicion of Covid-19).

Outcome Measures
Primary Outcome Measures :
  1. Rate of back pain [ Time Frame: Baseline ]
    given as percentage %

  2. Chest computed tomography [ Time Frame: Baseline ]
    Presence of covid-19 findings in chest computed tomography (covid findings positive or negative)

  3. Rate of low-back pain [ Time Frame: Baseline ]
    given as percentage %

  4. Rate of fatigue [ Time Frame: Baseline ]
    given as percentage %

  5. Rate of neck pain [ Time Frame: Baseline ]
    given as percentage %

  6. Rate of dyspnea [ Time Frame: baseline ]
    given as percentage %

  7. Rate of joint pain [ Time Frame: Baseline ]
    given as percentage %

  8. Rate of chest pain [ Time Frame: Baseline ]
    given as percentage %

  9. Rate of myalgia [ Time Frame: Baseline ]
    given as percentage %


Secondary Outcome Measures :
  1. age [ Time Frame: Baseline ]
    years

  2. Weight [ Time Frame: Baseline ]
    kilograms

  3. gender [ Time Frame: Baseline ]
    female or male

  4. Duration after the onset of covid-19 [ Time Frame: Baseline ]
    months

  5. Lymhocyte levels [ Time Frame: Baseline ]
    10*3 cells/microliter

  6. D-dimer levels [ Time Frame: Baseline ]
    miligram/Litre

  7. C-reactive protein [ Time Frame: Baseline ]
    miligram/Litre

  8. Hemoglobin [ Time Frame: Baseline ]
    gram/desilitre

  9. Platelet [ Time Frame: Baseline ]
    10*3 cells/microliter

  10. Ferritin [ Time Frame: Baseline ]
    nanogram/mililitre


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This retrospective cross-sectional study was carried out with the records of 280 post Covid-19 patients who admitted to the physical medicine and rehabilitation outpatient clinic between December 2020 and May 2021.
Criteria

Inclusion Criteria:

  • Being 18 years or older
  • Having Covid-19 treatment (home quarantine / hospital / intensive care unit) according to a positive polymerase chain reaction (PCR) test in a nasopharyngeal + oropharyngeal swab or chest CT.

Exclusion Criteria:

  • Patients who did not have musculoskeletal symptom records (admission symptoms and musculoskeletal symptoms such as; fatigue, spine / joint /muscle pain/ numbness) in patients files
  • Acute Covid-19 patients whose symptoms started less than 1 month
Contacts and Locations

Locations
Layout table for location information
Turkey
Eskişehir City Hospital
Eskişehir, Turkey
Sponsors and Collaborators
Eskisehir City Hospital
Investigators
Layout table for investigator information
Principal Investigator: Fulya Bakılan Eskişehir City Hospital
Tracking Information
First Submitted Date June 14, 2021
First Posted Date June 21, 2021
Last Update Posted Date June 21, 2021
Actual Study Start Date June 11, 2021
Actual Primary Completion Date June 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2021)
  • Rate of back pain [ Time Frame: Baseline ]
    given as percentage %
  • Chest computed tomography [ Time Frame: Baseline ]
    Presence of covid-19 findings in chest computed tomography (covid findings positive or negative)
  • Rate of low-back pain [ Time Frame: Baseline ]
    given as percentage %
  • Rate of fatigue [ Time Frame: Baseline ]
    given as percentage %
  • Rate of neck pain [ Time Frame: Baseline ]
    given as percentage %
  • Rate of dyspnea [ Time Frame: baseline ]
    given as percentage %
  • Rate of joint pain [ Time Frame: Baseline ]
    given as percentage %
  • Rate of chest pain [ Time Frame: Baseline ]
    given as percentage %
  • Rate of myalgia [ Time Frame: Baseline ]
    given as percentage %
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 18, 2021)
  • age [ Time Frame: Baseline ]
    years
  • Weight [ Time Frame: Baseline ]
    kilograms
  • gender [ Time Frame: Baseline ]
    female or male
  • Duration after the onset of covid-19 [ Time Frame: Baseline ]
    months
  • Lymhocyte levels [ Time Frame: Baseline ]
    10*3 cells/microliter
  • D-dimer levels [ Time Frame: Baseline ]
    miligram/Litre
  • C-reactive protein [ Time Frame: Baseline ]
    miligram/Litre
  • Hemoglobin [ Time Frame: Baseline ]
    gram/desilitre
  • Platelet [ Time Frame: Baseline ]
    10*3 cells/microliter
  • Ferritin [ Time Frame: Baseline ]
    nanogram/mililitre
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Musculoskeletal Symptoms in Post Acute Covid-19 Patients
Official Title Musculoskeletal Symptoms and Related Factors in Post Acute Covid-19 Patients
Brief Summary The patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared with the patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory, chest computed tomography findings.
Detailed Description

There is a lack of an overview of the factors associated with post acute-Covid-19 musculoskeletal symptoms. The aims are;1-to evaluate the most frequent admission symptoms and the frequency of musculoskeletal symptoms in post acute-Covid-19 patients,2-to determine the related factors with the post acute-Covid-19 musculoskeletal symptoms.

In this retrospective study; the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared wthe patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory (complete blood count, C-reactive protein, ferritin, D-dimer), chest computed tomography findings.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This retrospective cross-sectional study was carried out with the records of 280 post Covid-19 patients who admitted to the physical medicine and rehabilitation outpatient clinic between December 2020 and May 2021.
Condition
  • Covid19
  • Musculoskeletal Abnormalities
Intervention
  • Other: Survey
    A detailed anamnesis was retrospectively recorded about age, gender, body mass index, education, working, the presence of any chronic disease (diabetes mellitus, hypertension, chronic obstructive pulmonary disease, cardiac disease, cancer, rheumatological disease…), smoking, duration of symptoms, usage of supplementing vitamins such as vitamin D,C, zinc…, treatment place (home quarantine, hospital, intensive care unit), duration of home quarantine and hospital treatment, the number of months since the onset of Covid-19 symptoms, usage of anticoagulants, treatment drugs such as hydroxychloroquine, favipiravir. Also the symptoms during the period of Covid-19 infection were recorded from patient files; cough, fever, dyspnea, chest pain, loss of smell and taste, sore throat, headache, no symptom, musculoskeletal symptoms such as: muscle, low back, back, joint pain.
  • Other: Laboratory parameters
    The laboratory values of 182 patients, presence of chest computed tomography findings of 206 patients and symptoms of all patients during the period of Covid-19 infection, were retrospectively recorded. Laboratory values of hemoglobin, leucocyte, lymphocyte, platelet, C-reactive protein, erythrocyte sedimentation rate, ferritin, d-dimer, were recorded.
  • Other: chest computed tomography
    Typical findings of chest CT were; bilateral, multifocal, peripheral ground glass opacities with/without consolidation, including the fissures, close to visceral pleural surfaces. Covid-19 Reporting and Data System (CO-RADS) was used for chest CT. CO-RADS assigns scores from 1 (very low suspicion of Covid-19) to 5 (very high suspicion of Covid-19).
Study Groups/Cohorts
  • Change
    the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19 (n=240)
    Interventions:
    • Other: Survey
    • Other: Laboratory parameters
    • Other: chest computed tomography
  • No change
    the patients whose musculoskeletal symptoms did not change with Covid-19 (n=40)
    Interventions:
    • Other: Survey
    • Other: Laboratory parameters
    • Other: chest computed tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2021)
280
Original Actual Enrollment Same as current
Actual Study Completion Date June 14, 2021
Actual Primary Completion Date June 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Being 18 years or older
  • Having Covid-19 treatment (home quarantine / hospital / intensive care unit) according to a positive polymerase chain reaction (PCR) test in a nasopharyngeal + oropharyngeal swab or chest CT.

Exclusion Criteria:

  • Patients who did not have musculoskeletal symptom records (admission symptoms and musculoskeletal symptoms such as; fatigue, spine / joint /muscle pain/ numbness) in patients files
  • Acute Covid-19 patients whose symptoms started less than 1 month
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04932889
Other Study ID Numbers EskisehirCityH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: one year later, after my manuscript publishes in a journal.
Responsible Party Fulya Bakılan, Eskisehir City Hospital
Study Sponsor Eskisehir City Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Fulya Bakılan Eskişehir City Hospital
PRS Account Eskisehir City Hospital
Verification Date June 2021