Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire

Quality of Life Clinical Trial

— QolAISSRS22  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915106
• Other study ID #: 2019.213
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: July 2027

Study information

• Verified date: December 2023
• Source: Chinese University of Hong Kong
• Contact: Alec Lik-Hang Hung, Dr.
• Phone: (852)55699593
• Email: hlh378[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Quality of Life
• Scoliosis
• Scoliosis; Adolescence
• SRS

Intervention

Device:
• Brace
Wear a rigid brace

Procedure:
• Surgical correction using implants
Surgical correction of spine using implants (metallic rods and metallic screws)

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 1 year
Primary	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.	Baseline and 1 year
Primary	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.	Baseline and 1 year
Primary	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.	Baseline and 1 year
Primary	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.	Baseline and 1 year