NCT04932889

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

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

June 11, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

2 days

First QC Date

June 14, 2021

Last Update Submit

June 18, 2021

Conditions

Outcome Measures

Primary Outcomes (9)

  • Rate of back pain

    given as percentage %

    Baseline

  • Chest computed tomography

    Presence of covid-19 findings in chest computed tomography (covid findings positive or negative)

    Baseline

  • Rate of low-back pain

    given as percentage %

    Baseline

  • Rate of fatigue

    given as percentage %

    Baseline

  • Rate of neck pain

    given as percentage %

    Baseline

  • Rate of dyspnea

    given as percentage %

    baseline

  • Rate of joint pain

    given as percentage %

    Baseline

  • Rate of chest pain

    given as percentage %

    Baseline

  • Rate of myalgia

    given as percentage %

    Baseline

Secondary Outcomes (10)

  • age

    Baseline

  • Weight

    Baseline

  • gender

    Baseline

  • Duration after the onset of covid-19

    Baseline

  • Lymhocyte levels

    Baseline

  • +5 more secondary outcomes

Study Arms (2)

Change

the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19 (n=240)

Other: SurveyOther: Laboratory parametersOther: chest computed tomography

No change

the patients whose musculoskeletal symptoms did not change with Covid-19 (n=40)

Other: SurveyOther: Laboratory parametersOther: chest computed tomography

Interventions

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.

ChangeNo change

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.

ChangeNo change

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).

ChangeNo change

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir City Hospital

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Musculoskeletal Abnormalities

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fulya Bakılan

    Eskişehir City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in physical medicine and rehabilitation

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 21, 2021

Study Start

June 11, 2021

Primary Completion

June 13, 2021

Study Completion

June 14, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

one year later, after my manuscript publishes in a journal.

Locations