Assessing the Quality of Life in Adults With Spinal Deformity

Quality of Life Clinical Trial

Official title:

Assessing the Quality of Life in Adults With Spinal Deformity: a Retrospective Comparison Between Two Questionnaires

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05333757
• Other study ID #: A-ISYQOL
• Status: Completed
• Start date: March 31, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Istituto Scientifico Italiano Colonna Vertebrale
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Spinal deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools for this condition have been developed to investigate the extent of this impact, such as the SRS-22 questionnaire and ISYQOL questionnaire.

The latter was initially used for underage patients, but given that some of them continue their therapy and the monitoring beyond the age of 18, we have continued its use in these subjects as well. Given the clinical usefulness and given the lack of questionnaires developed in the Rasch environment for adults, we have extended the application of the ISYQOL questionnaire to the adult population. However, a comparison between the ISYQOL and SRS-22 in adults has not yet been made.

The objective of this study is to verify the validity of ISYQOL and to compare the properties of ISYQOL with those of the SRS-22 questionnaire in adults with spinal deformity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Diagnosis of idiopathic or degenerative scoliosis with =30 ° Cobb curve

Exclusion Criteria:

• Previous spinal surgery

• Previous and relevant illnesses, surgery or trauma

Related Conditions & MeSH terms

• Quality of Life
• Scoliosis

Intervention

Other:
• Questionnaire
Adults with spinal deformities were asked to complete two questionnaires assessing quality of life

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	Statistical properties of SRS-22 and ISYQOL questionnaire	The Spearman correlation coefficient will be used to evaluate the concurrent validity of ISYQOL questionnaire. Cronbach's alpha will be used to evaluate the internal validity of ISYQOL questionnaire.; Rasch analysis will be applied to explore the characteristics of the two tools. In addition, the reproducibility of the measurement. Usually, the goal is to obtain a reliability> 0.8.	through study completion, an average of 1 year