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

December 18, 2023 updated by: Gulsah Bargi, Izmir Democracy University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • İzmir, Turkey, 35140
        • Recruiting
        • İzmir Democracy University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Degree of vertebral rotation
Time Frame: through study completion, an average of 1 year
Degree of vertebral rotation will be evaluated through a scoliometer.
through study completion, an average of 1 year
Pain severity
Time Frame: through study completion, an average of 1 year
Pain severity will be assessed via Pressure Algometry
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Democracy University

Investigators

  • Study Director: GÜLŞAH BARĞI, İzmir Democracy University
  • Principal Investigator: MERVE NUR YÜKSEL, İzmir Democracy University
  • Principal Investigator: ALİ ERTUĞRUL, Balikesir Ataturk City Hospital
  • Principal Investigator: RUKİYE YAZICI, Atatürk, Balikesir State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effects of COVID on scoliosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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