- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04932889
Musculoskeletal Symptoms in Post Acute Covid-19 Patients
Musculoskeletal Symptoms and Related Factors in Post Acute Covid-19 Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Eskişehir, Turkey
- Eskişehir City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Change
the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19 (n=240)
|
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.
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.
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)
|
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.
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.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of back pain
Time Frame: Baseline
|
given as percentage %
|
Baseline
|
|
Chest computed tomography
Time Frame: Baseline
|
Presence of covid-19 findings in chest computed tomography (covid findings positive or negative)
|
Baseline
|
|
Rate of low-back pain
Time Frame: Baseline
|
given as percentage %
|
Baseline
|
|
Rate of fatigue
Time Frame: Baseline
|
given as percentage %
|
Baseline
|
|
Rate of neck pain
Time Frame: Baseline
|
given as percentage %
|
Baseline
|
|
Rate of dyspnea
Time Frame: baseline
|
given as percentage %
|
baseline
|
|
Rate of joint pain
Time Frame: Baseline
|
given as percentage %
|
Baseline
|
|
Rate of chest pain
Time Frame: Baseline
|
given as percentage %
|
Baseline
|
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Rate of myalgia
Time Frame: Baseline
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given as percentage %
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
age
Time Frame: Baseline
|
years
|
Baseline
|
|
Weight
Time Frame: Baseline
|
kilograms
|
Baseline
|
|
gender
Time Frame: Baseline
|
female or male
|
Baseline
|
|
Duration after the onset of covid-19
Time Frame: Baseline
|
months
|
Baseline
|
|
Lymhocyte levels
Time Frame: Baseline
|
10*3 cells/microliter
|
Baseline
|
|
D-dimer levels
Time Frame: Baseline
|
miligram/Litre
|
Baseline
|
|
C-reactive protein
Time Frame: Baseline
|
miligram/Litre
|
Baseline
|
|
Hemoglobin
Time Frame: Baseline
|
gram/desilitre
|
Baseline
|
|
Platelet
Time Frame: Baseline
|
10*3 cells/microliter
|
Baseline
|
|
Ferritin
Time Frame: Baseline
|
nanogram/mililitre
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Congenital Abnormalities
- Musculoskeletal Diseases
- COVID-19
- Musculoskeletal Abnormalities
Other Study ID Numbers
- EskisehirCityH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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