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Pain, Physical Activity, Posture and Quality of Life in Post-COVID-19 Individuals With Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT06006897
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : December 19, 2023
Sponsor:
Information provided by (Responsible Party):
Gulsah Bargi, Izmir Democracy University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
It is not known to what extent the COVID-19 virus affects individuals with scoliosis during the prolonged COVID-19 pandemic. Therefore, in this study it was aimed to comparatively investigate pain severity, posture disorders that can be assessed by artificial intelligence, physical activity levels and quality of life in individuals with idiopathic scoliosis with and without COVID-19.

Condition or disease Intervention/treatment
COVID-19 Respiratory Infection Idiopathic Scoliosis Other: Physical Evaluations of post-COVID-19 individuals Other: Physical evaluations of non-post-COVID-19 individuals

Detailed Description:

Various physical and psychological disorders observed in individuals with scoliosis have worsened during the pandemic period. However, it is still not fully known to what extent the COVID-19 virus affects individuals with scoliosis during the prolonged COVID-19 pandemic. For this reason, this study aimed to comparatively investigate pain severity, posture disorders that can be assessed by artificial intelligence, physical activity levels and quality of life in individuals with idiopathic scoliosis with and without COVID-19.

With the findings obtained from this way, it is expect that artificial intelligence technology will shed light on a new approach to the rehabilitation of individuals with idiopathic scoliosis who have suffered from COVID-19. In addition, if there is more pain, posture disorders, physical inactivity and quality of life disorders in individuals with scoliosis who have previously experienced COVID-19, it is also aimed to bring them to light. In this way, it will be possible to provide more specific direction to the rehabilitation of these individuals.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Pain, Physical Activity, Posture and Quality of Life in Individuals With Idiopathic Scoliosis Who Have Had COVID-19
Actual Study Start Date : June 16, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Post-COVID-19 group
This group will consist of individuals with idiopathic scoliosis who have had COVID-19.
 Other: Physical Evaluations of post-COVID-19 individuals
In this study, scoliosis degree measurement, number of steps, pain, posture and quality of life will be evaluated in idiopathic scoliosis with post-COVID-19 individuals. The data to be obtained from all these evaluations will be collected from the individuals at one time and over a period of approximately 1 hour at the most. Step count tracking with pedometer will be done for each individual for 3 days.
Control group
The control group will consist of individuals with idiopathic scoliosis without post-COVID-19.
 Other: Physical evaluations of non-post-COVID-19 individuals
In this study, scoliosis degree measurement, number of steps, pain, posture and quality of life will be evaluated in idiopathic scoliosis without post-COVID-19 individuals.


Outcome Measures
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Primary Outcome Measures :
  1. Daily average step count [ Time Frame: through study completion, an average of 1 year ]
    The step counts will be recorded via pedometers everyday within 3 days after confirming enrolment.


Secondary Outcome Measures :
  1. Pain Intensity measured with the Numerical Rating Scale. [ Time Frame: through study completion, an average of 1 year ]
    Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain).

  2. Total quality of life score evaluated by Scoliosis Research Society-22 (SRS-22) questionnaire. [ Time Frame: through study completion, an average of 1 year ]
    The score will be evaluated using Scoliosis Research Society-22 (SRS-22) questionnaire. SRS-22 contains 22 questions. Each question is scored from 1 (worst) to 5 (best), with higher scores indicating better results. The minimum score obtained from the questionnaire is 22 and the maximum total score is 110.

  3. Posture assessment [ Time Frame: through study completion, an average of 1 year ]
    Posture deviation will be determined according to the deviation score in the joint centers obtained by photographing the posture of the individuals and uploading them to the system. Posture assessment will be made with a mobile application based on the concept of postural analysis with artificial intelligence.

  4. Degree of vertebral rotation [ Time Frame: through study completion, an average of 1 year ]
    Degree of vertebral rotation will be evaluated through a scoliometer.

  5. Pain severity [ Time Frame: through study completion, an average of 1 year ]
    Pain severity will be assessed via Pressure Algometry


Eligibility Criteria
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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
At least 25 idiopathic scoliosis with post-COVID-19 will be included in the main group and at least 25 idiopathic scoliosis without post-COVID-19 will be included in control group.
Criteria

Inclusion Criteria for individuals with idiopathic scoliosis who have experienced COVID-19:

  • being 18 years of age or older
  • Volunteering to participate in the study
  • Having been diagnosed with idiopathic scoliosis
  • Being able to walk independently
  • Having been diagnosed with COVID-19 and having recovered and been discharged.

Inclusion criteria for individuals with idiopathic scoliosis who have not had COVID-19;

  • being 18 years of age or older
  • Volunteering to participate in the study
  • Being diagnosed with idiopathic scoliosis

Exclusion criteria for individuals with idiopathic scoliosis who have had COVID-19;

  • Having been diagnosed with COVID-19 in the last 15 days
  • Being suspected of COVID-19
  • Having mental problems that may affect cooperation
  • Having an acute or chronic infection that may affect the evaluations to be made within the scope of the study.
  • Participating in any professional sports activity
  • Having any surgery to prevent walking, having a chronic disease, orthopedic/neurological/cardiopulmonary disease, physical or mental disability and/or cognitive impairment
  • Using analgesics and other interactive drugs that will affect assessments
  • Being pregnant

Exclusion criteria for individuals with idiopathic scoliosis who have not had COVID-19;

  • Having had at least one COVID-19
  • Being suspected of COVID-19
  • Having any mental or physical disability
  • Having any acute or chronic illness
  • Having analgesic drug use that will affect the evaluations . Being pregnant
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06006897


Contacts
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Contact: GÜLŞAH BARĞI +90 232 299 0739 gulsahbargi35@gmail.com
Contact: MERVE NUR YÜKSEL merv.yuksel94@gmail.com

Locations
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Turkey
Izmir Democracy University Recruiting
İzmir, Turkey, 35140
Contact: GÜLŞAH BARĞI, PHD    +905317938766    gulsah.bargi@idu.edu.tr   
Sponsors and Collaborators
Izmir Democracy University
Investigators
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Study Director: GÜLŞAH BARĞI Izmir Democracy University
Principal Investigator: MERVE NUR YÜKSEL Izmir Democracy University
Principal Investigator: ALİ ERTUĞRUL Balikesir Ataturk City Hospital
Principal Investigator: RUKİYE YAZICI Atatürk, Balikesir State Hospital
More Information
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Publications:

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Responsible Party: Gulsah Bargi, Associate Professor, Principal Investigator, Izmir Democracy University
ClinicalTrials.gov Identifier: NCT06006897    
Other Study ID Numbers: Effects of COVID on scoliosis
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: December 19, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gulsah Bargi, Izmir Democracy University:
pain
physical activity
posture
quality of life
Scoliosis
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Scoliosis
Pneumonia, Viral
Pneumonia
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases