NCT06006897

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

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 16, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

August 21, 2023

Last Update Submit

May 21, 2025

Conditions

Keywords

painphysical activityposturequality of lifeScoliosis

Outcome Measures

Primary Outcomes (1)

  • Daily average step count

    The step counts will be recorded via pedometers everyday within 3 days after confirming enrolment.

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • Pain Intensity measured with the Numerical Rating Scale.

    through study completion, an average of 1 year

  • Total quality of life score evaluated by Scoliosis Research Society-22 (SRS-22) questionnaire.

    through study completion, an average of 1 year

  • Posture assessment

    through study completion, an average of 1 year

  • Degree of vertebral rotation

    through study completion, an average of 1 year

  • Pain severity

    through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

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.

Post-COVID-19 group

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.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (2)

  • Kieser DC, Bourghli A, Larrieu D, Cawley DT, Hayashi K, Jakinapally S, Pizones J, Boissiere L, Obeid I. Impact of COVID-19 on the pain and disability of patients with adult spinal deformity. Spine Deform. 2021 Jul;9(4):1073-1076. doi: 10.1007/s43390-021-00315-5. Epub 2021 Mar 2.

    PMID: 33651340BACKGROUND
  • Suarez-Huerta ML, Gomez-Rice A, Carvajal Alvarez M, Vazquez Vecilla IC, Izquierdo-Nunez E, Fernandez-Gonzalez M, Zuniga-Gomez L, Betegon-Nicolas J, Sanchez-Campos S. Effect of COVID-19 on quality of life of persons aged >70 years with adult spinal deformity: A cross-sectional case-control study. Medicine (Baltimore). 2022 Aug 19;101(33):e29954. doi: 10.1097/MD.0000000000029954.

    PMID: 35984207BACKGROUND

MeSH Terms

Conditions

PainMotor ActivityScoliosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • GÜLŞAH BARĞI

    Izmir Democracy University

    STUDY DIRECTOR
  • MERVE NUR YÜKSEL

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • ALİ ERTUĞRUL

    Balikesir Ataturk City Hospital

    PRINCIPAL INVESTIGATOR
  • RUKİYE YAZICI

    Atatürk, Balikesir State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 23, 2023

Study Start

June 16, 2023

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations