Clinical trial NCT06006897: Pain, Physical Activity, Posture and Quality of Life in Post-COVID-19 Individuals With Idiopathic Scoliosis
Official title: Pain, Physical Activity, Posture and Quality of Life in Individuals With Idiopathic Scoliosis Who Have Had COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Respiratory Infection
Idiopathic Scoliosis
Keywords: pain
physical activity
posture
quality of life
Scoliosis
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Daily average step count
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Pain Intensity measured with the Numerical Rating Scale.
timeFrame: through study completion, an average of 1 year
measure: Total quality of life score evaluated by Scoliosis Research Society-22 (SRS-22) questionnaire.
timeFrame: through study completion, an average of 1 year
measure: Posture assessment
timeFrame: through study completion, an average of 1 year
measure: Degree of vertebral rotation
timeFrame: through study completion, an average of 1 year
measure: Pain severity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: GÜLŞAH BARĞI
role: STUDY_DIRECTOR
affiliation: Izmir Democracy University
name: MERVE NUR YÜKSEL
role: PRINCIPAL_INVESTIGATOR
affiliation: Balikesir Ataturk City Hospital
name: ALİ ERTUĞRUL
role: PRINCIPAL_INVESTIGATOR
affiliation: Atatürk, Balikesir State Hospital
name: RUKİYE YAZICI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.