Condition category
Musculoskeletal Diseases
Date applied
18/08/2015
Date assigned
20/08/2015
Last edited
20/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jihea Choi

ORCID ID

Contact details

Jinri-Hall 402-4
Department of Nursing
Yonsei University Wonju College of Medicine
20 Ilsan-ro
Wonju-si
Gangwon-do
220-701
Korea
South

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

Organisation

Severance Hospital

Sponsor details

50-1 Yeonsei-Ro
Seodaemun-Gu
Seoul
03722
Korea
South

Sponsor type

Hospital/treatment centre

Website

Organisation

KangNam Severance Hospital

Sponsor details

211 Eonju-Ro Gangnam-Gu
Seoul
06273
Korea
South

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes