Validation of clinical measures for assessing spinal stiffness
Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth
This study is testing if certain clinical checks for spinal stiffness are reliable and accurate for patients with hyperkyphosis and scoliosis to help identify those who might struggle with treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Istituto Scientifico Italiano Colonna Vertebrale Academic / other |
| Locations | 1 site (Milan, Mi) |
| Trial ID | NCT05924581 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the reliability of clinical assessments used by healthcare professionals to measure spinal stiffness in patients with hyperkyphosis and adolescent idiopathic scoliosis. It will also evaluate the diagnostic accuracy of these assessments in identifying patients at risk of treatment failure, using retrospective radiographic data as a standard. The study will involve clinical evaluations of spinal stiffness and compare results between patients who achieved correction of spine curvature and those who did not.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 10 to 17 with scoliosis greater than 10° Cobb or hyperkyphosis greater than 50° Cobb.
Not a fit: Patients with a history of spinal surgery, back pain, or congenital scoliosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of spinal assessments, leading to better treatment outcomes for patients with spinal deformities.
How similar studies have performed: While similar studies have explored spinal assessments, this specific validation approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scoliosis \> 10°Cobb or Hyperkyophosis \>50° Cobb * Age between 10 and 17 years old * Risser between 0 and 5 Exclusion Criteria: * History of spinal surgery * Presence of back pain * Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases
Where this trial is running
Milan, Mi
- Isico — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Negrini, MD, PhD
- Email: stefano.negrini@isico.it
- Phone: +3902 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.