Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire (QolAISSRS22)
Evaluation of Health-related Quality of Life (HRQoL) of Adolescent Idiopathic Scoliosis (AIS) Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescent Idiopathic Scoliosis (AIS) is a 3D deformity of spine happened with unidentifiable cause at teenage. AIS causes mainly cosmetic problems with a lesser incidence of functional deficit and pain. AIS patients under severe condition, defined as the major spinal curve angle named "Cobb angle" larger than 60 degrees, requires surgical intervention to the spinal curve with implants permanently applied along the spine. The use of "brace" (bracing) to intervene the spinal curve progression is highly recommended for patients with particular clinical characteristics. However, bracing is not always a present experience apart from function restriction. Clinical recommendation requires the patients to brace over 20 hours everyday, which means the patients have to be "braced" around the clock. Patients' perception on being "braced" all day, apart from discomforts under bracing, self-image and mental health after bracing are also important psycho-social factors which have yet to be addressed. Based on our clinical experience, 1-2% of AIS patients, undergoing bracing or not (i.e. at observation stage), require surgical intervention due to rapid spinal progression in a short period of time. By definition, surgery will be arranged for patients with major spinal curve ≥50 degrees.
The health-related-quality-of-life (HRQoL) questionnaires allow clinical professionals to explore many areas of interest, including the patient's perception of his/her condition and satisfaction with provided care. Scoliosis Research Society (SRS) Outcomes Instrument has been an accepted HRQoL questionnaire to evaluate the perception of patients with spinal deformities of their status. The SRS-22 questionnaire that has been shown to have high reliability and concurrent validity and discrimination validity and responsiveness to change. SRS-22 questionnaire comprises 22 questions under 5 domains (function, pain, self-image, mental health, and satisfaction with management). Through these 22 questions, the psycho-social status can be quantified in terms of "scores" and the scores obtained at different time points can be compared. Continuous monitoring of these factors are important along the bracing period to look for patients with continuously poor psycho-social status of which bracing period is possibly last for years. Apart from AIS patients requiring bracing, surgical cases are also very important group of patients to monitor their quality of life before and after surgery, and every follow-up visit after surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alec Lik-Hang Hung, Dr.
- Phone Number: (852)55699593
- Email: hlh378@ha.org.hk
Study Locations
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Sha Tin, Hong Kong
- Recruiting
- Prince of Wales Hospital
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Contact:
- Alec Lik-Hang Hung, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- AIS patients who attend the scoliosis clinic at specialized outpatient clinic in Prince of Wales hospital and require wearing brace, or patients who suffer from severe scoliosis and require surgery on their first clinic visit
- Can read and understand either English or Chinese
Exclusion Criteria:
- To observe (i.e. not require to wear brace) after clinic visit
- Cannot read or understand either English or Chinese
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bracing
AIS patients undergoing bracing to control the spinal curve progression
|
Wear a rigid brace
|
|
Surgical
Severe AIS patients requiring surgical intervention to correct the spinal curve
|
Surgical correction of spine using implants (metallic rods and metallic screws)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline SRS-22 Function score at 1 year
Time Frame: Baseline and 1 year
|
Select 1 from 5 answers in each question.
Scores from 1 to 5 (1, 2, 3, 4, and 5), the higher score the better outcome.
A calculated score.
"Function" score was calculated by adding the scores from questions 1 to 4.
|
Baseline and 1 year
|
|
Change from baseline SRS-22 Pain score at 1 year
Time Frame: Baseline and 1 year
|
Select 1 from 5 answers in each question.
Scores from 1 to 5 (1, 2, 3, 4, and 5), the higher score the better outcome.
A calculated score.
"Pain" score was calculated by adding the scores from questions 5 to 8.
|
Baseline and 1 year
|
|
Change from baseline SRS-22 Self-image score at 1 year
Time Frame: Baseline and 1 year
|
Select 1 from 5 answers in each question.
Scores from 1 to 5 (1, 2, 3, 4, and 5), the higher score the better outcome.
A calculated score.
"Self-image" score was calculated by adding the scores from questions 9 to 12.
|
Baseline and 1 year
|
|
Change from baseline SRS-22 Mental score at 1 year
Time Frame: Baseline and 1 year
|
Select 1 from 5 answers in each question.
Scores from 1 to 5 (1, 2, 3, 4, and 5), the higher score the better outcome.
A calculated score.
"Mental" score was calculated by adding the scores from questions 13 to 16.
|
Baseline and 1 year
|
|
Change from baseline SRS-22 Satisfaction score at 1 year
Time Frame: Baseline and 1 year
|
Select 1 from 5 answers in each question.
Scores from 1 to 5 (1, 2, 3, 4, and 5), the higher score the better outcome.
A calculated score.
"Satisfaction" score was calculated by adding the scores from questions 17 to 20.
|
Baseline and 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alec Lik-Hang Hung, Dr., Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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