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

NCT03915106 | Recruiting DMC

• 1 other identifier: 2019.213
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescence; Adolescent; Quality of Life; SRS

Keywords

scoliosis; adolescent idiopathic scoliosis; bracing; surgery; quality of life; questionnaire

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Bracing

AIS patients undergoing bracing to control the spinal curve progression

Device: Brace

Surgical

Severe AIS patients requiring surgical intervention to correct the spinal curve

Procedure: Surgical correction using implants

Interventions

Brace DEVICE

Wear a rigid brace

Bracing

Surgical correction using implants PROCEDURE

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

Surgical

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients visiting a specialized clinic at Prince of Wales Hospital, Shatin, Hong Kong

You may qualify if:

• 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

You may not qualify if:

• To observe (i.e. not require to wear brace) after clinic visit
• Cannot read or understand either English or Chinese

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

Braces

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Alec Lik-Hang Hung, Dr.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alec Lik-Hang Hung, Dr.

CONTACT

(852)55699593; hlh378@ha.org.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: July 1, 2019
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)