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Validation of Clinical Assessment of Spinal Stiffness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05924581
Recruitment Status : Recruiting
First Posted : June 29, 2023
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Italiano Colonna Vertebrale

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperkyphosis Adolescent Idiopathic Scoliosis Other: Clinical assessment of spinal stiffness Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth
Actual Study Start Date : June 6, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Reliability [ Time Frame: through study completion, an average of 6 months ]
    Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated

  2. Repeatability [ Time Frame: through study completion, an average of 6 months ]
    Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests

  3. Diagnostic accuracy [ Time Frame: through study completion, an average of 6 months ]
    diagnostic sensitivity and specificity of each test


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05924581


Contacts
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Contact: Stefano Negrini, MD, PhD +3902 8416 1700 stefano.negrini@isico.it
Contact: Alessandra Negrini +3902 8416 1700 alessandra.negrini@isico.it

Locations
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Italy
ISICO Recruiting
Milan, Mi, Italy, 20141
Contact: Stefano Negrini, MD    0039 02 84161700    stefano.negrini@isico.it   
Sponsors and Collaborators
Istituto Scientifico Italiano Colonna Vertebrale
More Information
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Responsible Party: Istituto Scientifico Italiano Colonna Vertebrale
ClinicalTrials.gov Identifier: NCT05924581    
Other Study ID Numbers: ClinTest-HKS
First Posted: June 29, 2023    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be deposited in an online repository

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scoliosis
Kyphosis
Spinal Curvatures
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases