Validation of Clinical Assessment of Spinal Stiffness

Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth

This study aims to validate and verify the reliability of the clinical measures used in the daily routine by doctors and therapists that allow assessing the spinal stiffness in all spatial planes. The secondary objective is the verification of the diagnostic accuracy of the most reliable tests in identifying the subjects at risk of failure, using as a radiographic standard the examinations performed by the patients during the treatment (data retrieved retrospectively) using as a control group those patients who did not obtain a correction of the spine curvature.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis; Hyperkyphosis
• Intervention / Treatment: Other: Clinical assessment of spinal stiffness

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Negrini, MD, PhD; Phone Number: +3902 8416 1700; Email: stefano.negrini@isico.it
• Study Contact Backup: Name: Alessandra Negrini; Phone Number: +3902 8416 1700; Email: alessandra.negrini@isico.it

Study Locations

• Italy
  • Mi
    • Milan, Mi, Italy, 20141
      • Recruiting
      • ISICO
      • Contact: Stefano Negrini, MD; Phone Number: 0039 02 84161700; Email: stefano.negrini@isico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Clinical assessment of spinal stiffness; Patients' back flexibility will be assessed during the medical examination or physiotherapy session through one of the following non-invasive tests: Thoracic Stiffness Test (TST); Scoliosis stiffness test (SST); Kyphosis Stiffness Test (KST) Each test will be carried out at the beginning of the visit and repeated at the end 2 times by different operators, or once by the same operator to verify that the measurements taken at different times are reliable and that the measurements taken by two different operators are reliable.

Other: Clinical assessment of spinal stiffness; The clinical stiffness tests will be applied twice to the same patient by the same operator to verify intra-operator variability and twice by two operators at the same time to verify inter-operator variability. The verification of diagnostic accuracy with respect to the radiographic reference standard will be carried out retrospectively by using the data already available and systematically collected in electronic format during medical visits and physiotherapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability	Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated	through study completion, an average of 6 months
Repeatability	Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests	through study completion, an average of 6 months
Diagnostic accuracy	diagnostic sensitivity and specificity of each test	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Kyphosis
• Other Study ID Numbers: ClinTest-HKS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be deposited in an online repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No