ScoliosisNCT05424419
Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis
An observational study of Scoliosis, run by Technische Universität Dresden.
Trial summary
Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Brace therapy
- Type of treatment
- Surgery or procedure
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 1997to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with AIS were managed as recommended by SOSORT Consensus statement. Inclusion criteria were according to the Scoliosis Research Society criteria. Initial diagnostics included a clinical examination, standardized X-ray of the entire spine in standing position. Patients for whom cost coverage of double-brace therapy was denied by the health insurance company received a single full-day and nighttime Chêneau type brace treatment. All other patients received a Chêneau brace for daytime and a Charleston type nighttime bending brace. Patients who were prescribed the brace were instructed to wear it for 23 hours/day. Patients were seen at 6-month intervals, at which times we collected radiographic, clinical, orthotic, and self-reported data.
Who may be able to join
- AIS
- age between 10 and 15 years (y)
- Risser's sign of 0-2
- Cobb curvature angle of 25-40°
- no previous treatment
- compliance (at least 23 h wearing time)
Who cannot join
- non-idiopathic scoliosis
- Cobb curvature angle >40°
- <10 years and >15 years for initial treatment
About this study
Official title: Retrospektive Analyse Der Konservativen Skoliosetherapie - Doppelkorsettversorgung Mittels Tag- Und Nachtorthese Versus Ganztagesorthese
Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.
Read the detailed description
One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.
- Conditions
- Scoliosis
- Being tested
- Brace therapy
- Keywords
- scoliosis, nighttime bracing, full-time bracing, Chêneau brace, Charleston brace
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brace therapyProcedure or surgery
A Chêneau-type brace was made to be worn as a full-time brace or during daytime only (double-brace group), whereas the nighttime brace was produced according to the Charleston approach.
| Study group | Role | What they receive |
|---|---|---|
| double-brace group | AIS patients with daytime and nighttime braces Receives: Procedure: Brace therapy | |
| single-brace group | AIS patients with a single brace for day and night Receives: Procedure: Brace therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary correction
Primary correction (%) of brace therapy (Cobb angle measurement)
Measured: At study inclusion with initiation of brace therapy
Secondary outcomes (1)
Cobb angle reduction
Follow-up Cobb angle (degree) in relation to the initial Cobb angle
Measured: 2 years after deposition of the brace
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start2 Jan 1997
- Primary completion31 Dec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424419
- Sponsor's protocol ID
- EK 27012018
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospektive Analyse Der Konservativen Skoliosetherapie - Doppelkorsettversorgung Mittels Tag- Und Nachtorthese Versus Ganztagesorthese
- ClinicalTrials.gov ID
- NCT05424419
- Acronym / sponsor ID
- EK 27012018
- Conditions
- Scoliosis
- Keywords
- scoliosis, nighttime bracing, full-time bracing, Chêneau brace, Charleston brace
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 2 Jan 1997 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.
Detailed description
One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double-brace group | – | Procedure: Brace therapyAIS patients with daytime and nighttime braces |
| single-brace group | – | Procedure: Brace therapyAIS patients with a single brace for day and night |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with AIS were managed as recommended by SOSORT Consensus statement. Inclusion criteria were according to the Scoliosis Research Society criteria. Initial diagnostics included a clinical examination, standardized X-ray of the entire spine in standing position. Patients for whom cost coverage of double-brace therapy was denied by the health insurance company received a single full-day and nighttime Chêneau type brace treatment. All other patients received a Chêneau brace for daytime and a Charleston type nighttime bending brace. Patients who were prescribed the brace were instructed to wear it for 23 hours/day. Patients were seen at 6-month intervals, at which times we collected radiographic, clinical, orthotic, and self-reported data.
Key inclusion criteria (6 listed)
- AIS
- age between 10 and 15 years (y)
- Risser's sign of 0-2
- Cobb curvature angle of 25-40°
- no previous treatment
Key exclusion criteria (3 listed)
- non-idiopathic scoliosis
- Cobb curvature angle >40°
- <10 years and >15 years for initial treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brace therapyA Chêneau-type brace was made to be worn as a full-time brace or during daytime only (double-brace group), whereas the nighttime brace was produced according to the Charleston approach. | Procedure or surgery | double-brace group, single-brace group |
Primary outcome
primary correction
Time frame: At study inclusion with initiation of brace therapy
Primary correction (%) of brace therapy (Cobb angle measurement)
1 secondary outcome
Cobb angle reduction
Time frame: 2 years after deposition of the brace
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Technische Universität Dresden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary correction (time frame: At study inclusion with initiation of brace therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.