Scoliosis; AdolescenceQolAISSRS22NCT03915106
Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire
An observational study of Scoliosis; Adolescence and Adolescent, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Adolescent Idiopathic Scoliosis (AIS) is an unexpected curvature of spine at teenage. AIS causes mainly unpleasant appearance, and sometime comes with pain and difficult to locate or move around. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scoliosis; Adolescence, Adolescent, Quality of Life
- What is being tested?
- Brace and Surgical correction using implants
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2019to Jul 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients visiting a specialized clinic at Prince of Wales Hospital, Shatin, Hong Kong
Who may be able to join
- 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
Who cannot join
- To observe (i.e. not require to wear brace) after clinic visit
- Cannot read or understand either English or Chinese
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Alec Lik-Hang Hung, Dr.
Alec Lik-Hang Hung, Dr.
About this study
Official title: Evaluation of Health-related Quality of Life (HRQoL) of Adolescent Idiopathic Scoliosis (AIS) Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire
Adolescent Idiopathic Scoliosis (AIS) is an unexpected curvature of spine at teenage. AIS causes mainly unpleasant appearance, and sometime comes with pain and difficult to locate or move around. When the spinal curve, or "Cobb angle", increases with time, the investigators call it severe condition when the Cobb angle is 60 degrees or above. The severe suffering patients need to be operated to correct their spinal curve by using metallic rods and metallic screws (implants) to fix the spine. In order to avoid this surgery, the investigators use "brace", a hard fitting case, trying to control the spinal curve degree by using forces from outside. (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. The use of health-related-quality-of-life (HRQoL) questionnaires allow clinical professionals to explore many different kinds of interests on patients, including the patient's feeling on his/her medical condition and satisfaction with provided care. Scoliosis Research Society (SRS) patient outcome tool has been a well-accepted HRQoL questionnaire to look for the perception of patients with spinal problems of their status. The SRS-22 questionnaire that has been well accepted as its trustworthy on the score results and SRS-22 is good to be used in patients under different conditions across the disease. This is very important to obtain and compare the scores over time in order to look for any consistent changes. 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.
Read the 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.
- Conditions
- Scoliosis; Adolescence, Adolescent, Quality of Life, SRS
- Being tested
- Brace, Surgical correction using implants
- Keywords
- scoliosis, adolescent idiopathic scoliosis, bracing, surgery, quality of life, questionnaire
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BraceDevice
Wear a rigid brace
Surgical correction using implantsProcedure or surgery
Surgical correction of spine using implants (metallic rods and metallic screws)
| Study group | Role | What they receive |
|---|---|---|
| Bracing | AIS patients undergoing bracing to control the spinal curve progression Receives: Device: Brace | |
| Surgical | Severe AIS patients requiring surgical intervention to correct the spinal curve Receives: Procedure: Surgical correction using implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline SRS-22 Function score at 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.
Measured: Baseline and 1 year
Change from baseline SRS-22 Pain score at 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.
Measured: Baseline and 1 year
Change from baseline SRS-22 Self-image score at 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.
Measured: Baseline and 1 year
Change from baseline SRS-22 Mental score at 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.
Measured: Baseline and 1 year
Change from baseline SRS-22 Satisfaction score at 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.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jul 2019
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alec Lik-Hang Hung, Chinese University of Hong Kong
- Investigators
- Alec Lik-Hang Hung, Dr., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915106
- Sponsor's protocol ID
- 2019.213
- Acronym
- QolAISSRS22
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No