Plain English Summary
Background and study aims
The spine is made up of a series of small bones called vertebrae. Scoliosis is a condition that causes the vertebrae to twist or rotate, causing the spine to curve sideways. There are several different types of scoliosis, however the most common type is known as “idiopathic”, which means that the exact cause is not known. Scoliosis can have a disfiguring effect on appearance. This is a particular problem in young people, who are often more concerned with the way their bodies look than adults, as it is a sensitive stage of development. It is thought that young people will experience a lot of emotional distress because of their condition, which can have an effect on their quality of life. This study aims to see how young people suffering from idiopathic scoliosis feel about their quality of life in relation to the disease characteristics and characteristics of the general population.
Who can participate?
Patients between the ages of 8 and 20 suffering from idiopathic scoliosis.
What does the study involve?
Participants are asked to fill in a questionnaire designed to find out how good they feel their quality of life is. The medical records of the participants are also reviewed by the researchers to collect information about how serious their disease is, the type of treatment they are having, and the age when the disease was first diagnosed.
What are the possible benefits and risks of participating?
There are no benefits of participating in the study other than providing new insight and valuable information of HRQoL of Korean adolescents with idiopathic scoliosis. There are no risks of participating.
Where is the study run from?
1. Severance Hosptial (South Korea)
2. Kangnam Severance Hospital (South Korea)
When is the study starting and how long is it expected to run for?
November 2010 to August 2012
Who is funding the study?
Mo-Im Nursing Research Institute of Yonsei University (South Korea)
Who is the main contact?
Professor Jihea Choi
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Health-related quality of life of young adolescents conservatively treated for idiopathic scoliosis in Korea: a cross-sectional study
Acronym
Study hypothesis
This cross-sectional study aims to describe and compare health-related quality of life (HRQoL) of adolescents with idiopathic scoliosis by disease-related characteristics such as age of diagnosis, type of treatment, severity of idiopathic scoliosis, as well as demographic characteristics.
Ethics approval
1. Institutional Review Board of Gangnam Severance Hospital: 24/11/2010, ref: 3-2010-0172
2. Clinical Trials Center (CTC) of Severance Hospital: 22/12/2011, ref: 4-2011-0682
Study design
Multi-centre observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Scoliosis
Intervention
One hundred and ten adolescents with idiopathic scoliosis were recruited from two tertiary hospital outpatient clinics over 1 year. Health-related quality of life (HRQoL) of participants was measured using the Korean version of the Scoliosis Research Society 22 revision (SRS-22r) questionnaire. In addition, their medical records were reviewed to collect data on severity of scoliosis, type of treatment, and age at which they were first diagnosed with the disease.
Intervention type
Phase
Drug names
Primary outcome measures
Health-related quality of life (HRQoL) is measured during clinical visits, measured using the Korean version of the Scoliosis Research Society 22 revision (SRS-22r) questionnaire. The SRS-22r contains 22 questions in five domains: function (5 items), pain (5 items), self-image (5 items), mental health (5 items), and satisfaction with management (2 items). Each item contains 5 response levels from worst (1 point) to best (5 point), and the results are expressed as the mean score of each domain and total score of the scale. A higher total score indicates a higher level of quality of life.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
24/11/2010
Overall trial end date
30/08/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 8 and 20 years
2. Having a primary diagnosis of idiopathic scoliosis.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
One hundred and ten adolescents with idiopathic scoliosis were recruited.
Participant exclusion criteria
Any other diagnosable musculoskeletal disease, except for scoliosis and cognitive impairment.
Recruitment start date
24/11/2010
Recruitment end date
30/08/2012
Locations
Countries of recruitment
Korea, South
Trial participating centre
Severance Hospital
Seoul
03722
Korea, South
Trial participating centre
Kangnam Severance Hospital
Seoul
06273
Korea, South
Sponsor information
Funders
Funder type
University/education
Funder name
Mo-Im Nursing Research Institute of Yonsei University (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intend to submit to the journal "Scoliosis" (http://www.scoliosisjournal.com/)
Intention to publish date
30/09/2015
Participant level data
Available on request
Results - basic reporting
Publication summary