Covid19NCT04932889
Musculoskeletal Symptoms in Post Acute Covid-19 Patients
An observational study of Covid19 and Musculoskeletal Abnormalities, run by Eskisehir City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Musculoskeletal Abnormalities
- What is being tested?
- Survey, Laboratory parameters and chest computed tomography
- How many people
- 280 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2021to 14 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Musculoskeletal Symptoms and Related Factors in Post Acute Covid-19 Patients
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.
Read the 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.
- Conditions
- Covid19, Musculoskeletal Abnormalities
- Being tested
- Survey, Laboratory parameters, chest computed tomography
- Medical subject headings
- COVID-19, Musculoskeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
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.
Laboratory parametersOther
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.
chest computed tomographyOther
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 group | Role | What they receive |
|---|---|---|
| Change | the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19 (n=240) Receives: Other: Survey; Other: Laboratory parameters; Other: chest computed tomography | |
| No change | the patients whose musculoskeletal symptoms did not change with Covid-19 (n=40) Receives: Other: Survey; Other: Laboratory parameters; Other: chest computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of back pain
given as percentage %
Measured: Baseline
Chest computed tomography
Presence of covid-19 findings in chest computed tomography (covid findings positive or negative)
Measured: Baseline
Rate of low-back pain
given as percentage %
Measured: Baseline
Rate of fatigue
given as percentage %
Measured: Baseline
Rate of neck pain
given as percentage %
Measured: Baseline
Rate of dyspnea
given as percentage %
Measured: baseline
Rate of joint pain
given as percentage %
Measured: Baseline
Rate of chest pain
given as percentage %
Measured: Baseline
Rate of myalgia
given as percentage %
Measured: Baseline
Secondary outcomes (10)
age
years
Measured: Baseline
Weight
kilograms
Measured: Baseline
gender
female or male
Measured: Baseline
Duration after the onset of covid-19
months
Measured: Baseline
Lymhocyte levels
10*3 cells/microliter
Measured: Baseline
D-dimer levels
miligram/Litre
Measured: Baseline
C-reactive protein
miligram/Litre
Measured: Baseline
Hemoglobin
gram/desilitre
Measured: Baseline
Platelet
10*3 cells/microliter
Measured: Baseline
Ferritin
nanogram/mililitre
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start11 Jun 2021
- Primary completion13 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Bakılan, Eskisehir City Hospital
- Investigators
- Fulya Bakılan, Principal investigator, Eskişehir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932889
- Sponsor's protocol ID
- EskisehirCityH
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: one year later, after my manuscript publishes in a journal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Symptoms and Related Factors in Post Acute Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04932889
- Acronym / sponsor ID
- EskisehirCityH
- Conditions
- Covid19, Musculoskeletal Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Eskisehir City HospitalUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Change | – | Other: Survey, Other: Laboratory parameters, Other: chest computed tomographythe patients whose musculoskeletal symptoms initiated or aggravated with Covid-19 (n=240) |
| No change | – | Other: Survey, Other: Laboratory parameters, Other: chest computed tomographythe patients whose musculoskeletal symptoms did not change with Covid-19 (n=40) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyA 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 | Change, No change |
| Laboratory parametersThe 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 | Change, No change |
| chest computed tomographyTypical 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). | Other | Change, No change |
Primary outcome
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 %
10 secondary outcomes
age
Time frame: Baseline
Weight
Time frame: Baseline
gender
Time frame: Baseline
Duration after the onset of covid-19
Time frame: Baseline
Lymhocyte levels
Time frame: Baseline
D-dimer levels
Time frame: Baseline
C-reactive protein
Time frame: Baseline
Hemoglobin
Time frame: Baseline
Platelet
Time frame: Baseline
Ferritin
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No. one year later, after my manuscript publishes in a journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fulya Bakılan principal investigator
Eskişehir City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Musculoskeletal Abnormalities, run by Eskisehir City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of back pain (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.