Scoliosis; JuvenileNCT05598021
Self-correction Evaluation in Scoliosis Patients
An observational study of Scoliosis; Juvenile and Scoliosis; Adolescence, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis. The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Scoliosis; Juvenile, Scoliosis; Adolescence
- How many people
- 185 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2022to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with adolescent and juvenile idiopathic scoliosis.
Who may be able to join
- Diagnosis of juvenile or adolescent idiopathic scoliosis;
- Age >= 10 years;
- Single and double curves with amplitude >= 15 ° Cobb;
- Performing exercises according to SEAS for at least 6 months
- Only for part 1 (radiographic)
- Availability of radiographic investigation in upright position and in self-correction Only for part 2 (ultrasound)
Show all 9Show fewer
- Availability of ultrasound assessment in upright position and in self-correction
- Complete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination.
- Risser between 0 and 2.
Who cannot join
- For both parts:
- Patients with more than 2 scoliotic curves
- Patients with secondary scoliosis
- Patients suffering from learning disabilities or clinical conditions impairing neuromotor control
- Patients lacking the necessary measures to evaluate the outcome.
- Part 2 only (ultrasound)
- ● Patients undergoing brace treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ISICO
Milan, Mi, 20141
Stefano Negrini, MD, 0039 02 84161700, stefano.negrini@isico.it
About this study
Official title: Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent
To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.
The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.
Read more
Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session.
Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).
- Conditions
- Scoliosis; Juvenile, Scoliosis; Adolescence
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound assessment | Quantitative comparison between ultrasound images performed in active self-correction and in a spontaneous position | |
| RX assessment | Quantitative comparison between radiological images performed in active self-correction and in a spontaneous position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-correction measure
The angular difference of the curves resulting from the detection with Scolioscan or Rx in the spontaneous position compared to what was obtained in the same condition but in the self-correcting position.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start5 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; JuvenileStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598021
- Sponsor's protocol ID
- Self-correction
- Status last verified
- May 2024
- First submitted
- 21 Oct 2022
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent
- ClinicalTrials.gov ID
- NCT05598021
- Acronym / sponsor ID
- Self-correction
- Conditions
- Scoliosis; Juvenile, Scoliosis; Adolescence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Oct 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.
To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.
The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.
Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session.
Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound assessment | – | –Quantitative comparison between ultrasound images performed in active self-correction and in a spontaneous position |
| RX assessment | – | –Quantitative comparison between radiological images performed in active self-correction and in a spontaneous position |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with adolescent and juvenile idiopathic scoliosis.
Key inclusion criteria (9 listed)
- Diagnosis of juvenile or adolescent idiopathic scoliosis;
- Age >= 10 years;
- Single and double curves with amplitude >= 15 ° Cobb;
- Performing exercises according to SEAS for at least 6 months
- Only for part 1 (radiographic)
Key exclusion criteria (7 listed)
- Patients with more than 2 scoliotic curves
- Patients with secondary scoliosis
- Patients suffering from learning disabilities or clinical conditions impairing neuromotor control
- Patients lacking the necessary measures to evaluate the outcome.
- Part 2 only (ultrasound)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-correction measure
Time frame: through study completion, an average of 6 months
The angular difference of the curves resulting from the detection with Scolioscan or Rx in the spontaneous position compared to what was obtained in the same condition but in the self-correcting position.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Juvenile and Scoliosis; Adolescence, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Negrini, MD (02 8416 1700, stefano.negrini@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-correction measure (time frame: through study completion, an average of 6 months). 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 10 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.