Evaluating self-correction in scoliosis patients
Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent
This study is testing how well young people with scoliosis can correct their own spine position using imaging techniques to see if they can improve their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 185 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Istituto Scientifico Italiano Colonna Vertebrale Academic / other |
| Locations | 1 site (Milan, Mi) |
| Trial ID | NCT05598021 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of self-correction in patients with juvenile and adolescent idiopathic scoliosis through two retrospective parts. The first part involves analyzing radiographic variations between spontaneous and self-corrected positions, while the second part utilizes non-invasive 3D ultrasound technology to measure these variations. Both assessments are conducted in a single session to ensure consistency. The study seeks to establish objective parameters for evaluating self-correction in scoliosis patients.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 10 and older diagnosed with juvenile or adolescent idiopathic scoliosis and exhibiting single or double curves of at least 15° Cobb.
Not a fit: Patients with more than two scoliotic curves or those undergoing brace treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for assessing self-correction in scoliosis, potentially improving treatment strategies.
How similar studies have performed: While this approach is innovative, similar studies assessing self-correction in scoliosis have not been widely reported, indicating a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan, Mi
- Isico — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Negrini, MD
- Email: stefano.negrini@unimi.it
- Phone: 02 8416 1700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.