Brace Weaning Protocol Comparing Gradual and Immediate Weaning
Study Details
Study Description
Brief Summary
This is a non-blinded, randomized controlled trial for testing two brace weaning protocols namely immediate removal of brace or gradual weaning of brace over a course of 6 months for adolescent idiopathic scoliosis (AIS) patients. These patients will have follow-up visits at 6-month and 12-month intervals. By comparing between the two groups in terms of change of Cobb angle, truncal balance, health-related quality of life measures and their health-care costs at the set time-points, the investigators aim to gain insights of whether different brace-weaning protocol will be more beneficial and cost-effective in patients' clinical and quality of life measure outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The aims of this study are: 1) To compare the degree of Cobb angle and truncal balance maintenance between immediate removal and gradual brace weaning protocols for AIS patients who have completed brace treatment; 2) To determine factors for poor maintenance of Cobb angle and truncal balance after brace weaning; 3) To determine if the current standardized criteria for initiating brace weaning is appropriate; and 4)To identify the most cost-effective bracing weaning protocol from health-care provider perspective.
The investigators' hypothesis is that an AIS patient requires gradual brace weaning to allow better adaptation to an unloaded environment without the brace thereby resulting with a better truncal balance. It is also hypothesized that the immediate removal of brace for a AIS patient is more cost-effective option for terminating bracing treatment when compared to gradual brace weaning over a 6-month period.
The investigators will recruit AIS patients managed at the Duchess of Kent Children's Hospital (DKCH) in Hong Kong. As there is no definition for "brace weaning", we adopt the protocol that our center has been using. Hence the investigators will be comparing two protocols: 1) brace wearing time shortened to night wearing for 6 more months before stopping bracing altogether or 2) immediate brace weaning on the day of patient recruitment. All patients will be recruited on the day of clinic consultation where the decision for brace weaning is made. Those with underarm (Boston) bracing are included in the study. All subjects are followed-up longitudinally up to 1 year after brace weaning has been issued. Hence this includes two clinic visits with one at 6 months to complete the gradual brace weaning protocol and another at 1 year to observe for any delayed changes to the overall curvature and balance including loss of truncal balance and Cobb angle deterioration. For curve progression after brace weaning, the highest risk occurs within 6 months of brace weaning. Hence, 1-year collection of data is adequate for seeing differences between the two groups. This does not deviate significantly from our usual care as all AIS subjects are usually followed-up at 6-monthly intervals and thus this duration of follow-up is strictly adherent to and standardized.
Eligible patients who have consented to take part will be randomly allocated to one of the two protocols, and group designation will be decided by a computer-generated randomized table. Restricted randomization through blocking will be used according to the equal proportion rule (1:1). The random allocation sequence will be managed independently, and the random coding is concealed to all research staff until all data analyses have been completed. The clinicians and research assistants will not be blinded to treatment allocation, as the participants are required to implement bracing protocols and schedule longitudinal follow-up.
Apart from the Cobb angle measurement, all subjects undergo weight, height and arm span measurements, health-related quality of life (HRQOL) and utility measurements, and whole spine standing posteroanterior (PA) and lateral radiographs at each clinic visit as per routine clinic protocol. The refined Scoliosis Research Society 22-item (SRS-22r) questionnaire and the EuroQoL 5-Dimension 5-Level (EQ5D) questionnaire will thus be provided at every visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Immediate Brace Weaning Immediate weaning of brace |
Other: Brace weaning
For AIS patients who have been wearing Boston brace and attend clinic consultation where the decision for brace weaning is made, then weaning protocol of either arm will be prescribed
|
| Other: Gradual Brace Weaning Nocturnal brace wearing for 6 months prior to stopping brace |
Other: Brace weaning
For AIS patients who have been wearing Boston brace and attend clinic consultation where the decision for brace weaning is made, then weaning protocol of either arm will be prescribed
|
Outcome Measures
Primary Outcome Measures
- Change of Cobb Angle [Baseline, then 6-month and 12-month follow-ups]
Cobb angle changes between the in-brace imaging performed at baseline (clinic where decision to initiate brace weaning is made) and subsequent 6 and 12-months follow-up.
Secondary Outcome Measures
- Truncal balance changes [Baseline, then 6-month and 12-month follow-ups]
Changes over time between the two groups/arms of brace-weaning protocol
- Healthcare costs [Baseline, then 6-month and 12-month follow-ups]
Information on resource use (bracing weaning, outpatient clinic visits, orthotic visits, allied health professional visits, hospital length of stay, complication treatment, physiotherapy visit, etc) will be collected and multiplied with their unit costs published in Hong Kong Government Gazette 2013.
- Health-related Quality of Life measure [Baseline, then 6-month and 12-month follow-ups]
The refined Chinese version of the Scoliosis Research Society-22 (SRS-22r) questionnaire
- Health-related Quality of Life measure [Baseline, then 6-month and 12-month follow-ups]
The EuroQol-5 dimension (EQ-5D) utility score
Eligibility Criteria
Criteria
Inclusion Criteria:
- AIS patients who have been wearing underarm (Boston) bracing, and who have reached skeletal maturity based on the Scoliosis Research Society (SRS) standardized criteria: Risser stage ≥4, >2 years post-menarche, and no growth between 2 visits. The subjects should be managed at the Duchess of Kent Children's Hospital (DKCH) in Hong Kong.
Exclusion Criteria:
- All patients that are not AIS, using Milwaukee bracing, unable to comply with study follow-up, protocol issued and refused consent for study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jason Pui Yin Cheung | Hong Kong | Please Select An Option Below | Hong Kong |
Sponsors and Collaborators
- The University of Hong Kong
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Braceweaning001