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

NCT ID: NCT03915106

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2029-07-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bracing

AIS patients undergoing bracing to control the spinal curve progression

Brace

Intervention Type: DEVICE

Wear a rigid brace

Surgical

Severe AIS patients requiring surgical intervention to correct the spinal curve

Surgical correction using implants

Intervention Type: PROCEDURE

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

Interventions

Brace

Wear a rigid brace

Intervention Type: DEVICE

Surgical correction using implants

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alec Lik-Hang Hung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alec Lik-Hang Hung, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Alec Lik-Hang Hung, Dr.

Role: CONTACT

hlh378@ha.org.hk

(852)55699593

Facility Contacts

Alec Lik-Hang Hung, Dr.

Role: primary

Other Identifiers

2019.213

Identifier Type: -

Identifier Source: org_study_id