Skip to content

Self-correction Evaluation in Scoliosis Patients

Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05598021
Enrollment
185
Registered
2022-10-28
Start date
2022-12-05
Completion date
2025-12-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis; Adolescence, Scoliosis; Juvenile

Brief 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. 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).

Interventions

None listed

Sponsors

Istituto Scientifico Italiano Colonna Vertebrale
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for both parts: * 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) * 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Self-correction measurethrough study completion, an average of 6 monthsThe 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.

Countries

Italy

Contacts

Primary ContactStefano Negrini, MD
stefano.negrini@unimi.it02 8416 1700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026