Assessing the Quality of Life in Adults With Spinal Deformity

Completed

• Conditions: Quality of Life; Scoliosis
• Interventions: Other: Questionnaire

• Registration Number: NCT05333757
• Lead Sponsor: Istituto Scientifico Italiano Colonna Vertebrale

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-31
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Quality of life	Questionnaire	Adult patients treated conservatively for idiopathic scoliosis or undergoing clinical monitoring who have completed both questionnaires at least once and simultaneously and who meet the following inclusion criteria: * Age ≥ 18 years * Diagnosis of idiopathic or degenerative scoliosis with curve ≥30 ° Cobb

Primary Outcome Measures

Name	Time	Method
Statistical properties of SRS-22 and ISYQOL questionnaire	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

ISICO; 🇮🇹 Milan, Mi, Italy