Self-correction Evaluation in Scoliosis Patients

Scoliosis; Adolescence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598021
• Other study ID #: Self-correction
• Status: Recruiting
• Start date: December 5, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Istituto Scientifico Italiano Colonna Vertebrale
• Contact: Stefano Negrini, MD
• Phone: 02 8416 1700
• Email: stefano.negrini[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis; Adolescence
• Scoliosis; Juvenile

Locations

Country	Name	City	State
Italy	ISICO	Milan	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Italiano Colonna Vertebrale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 6 months