NCT03915106 Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire
| NCT ID | NCT03915106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Scoliosis; Adolescence |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2019-07-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2019-07-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alec Lik-Hang Hung, Dr.
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT03915106 clinical trial?
This trial is open to participants of all sexes, studying Scoliosis; Adolescence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03915106 currently recruiting?
Yes, NCT03915106 is actively recruiting participants. Contact the research team at hlh378@ha.org.hk for enrollment information.
Where is the NCT03915106 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT03915106 clinical trial?
NCT03915106 is sponsored by Chinese University of Hong Kong. The principal investigator is Alec Lik-Hang Hung, Dr. at Chinese University of Hong Kong. The trial plans to enroll 2,000 participants.