COVID-19 Respiratory Infection Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | December 2024 |
| Est. primary completion date | September 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Izmir Democracy University | Izmir |
| Lead Sponsor | Collaborator |
|---|---|
| Izmir Democracy University |
Turkey,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Pain Intensity measured with the Numerical Rating Scale. | 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 | |
| Secondary | Total quality of life score evaluated by Scoliosis Research Society-22 (SRS-22) questionnaire. | 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 | |
| Secondary | Posture assessment | 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 | |
| Secondary | Degree of vertebral rotation | Degree of vertebral rotation will be evaluated through a scoliometer. | through study completion, an average of 1 year | |
| Secondary | Pain severity | Pain severity will be assessed via Pressure Algometry | through study completion, an average of 1 year |