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

NCT03915106 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-02-12

No results posted yet for this study

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

Interventions

DEVICE

Brace

Wear a rigid brace

PROCEDURE

Surgical correction using implants

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Alec Lik-Hang Hung, Dr. · Chinese University of Hong Kong

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2028-07-31
Completion
2029-07-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03915106 on ClinicalTrials.gov