Assessing the Quality of Life in Adults With Spinal Deformity

NCT05333757 | Completed

• 1 other identifier: A-ISYQOL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Quality of life

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

Other: Questionnaire

Interventions

Questionnaire OTHER

Adults with spinal deformities were asked to complete two questionnaires assessing quality of life

Quality of life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated conservatively for idiopathic scoliosis or undergoing clinical monitoring

You may qualify if:

• Age ≥ 18 years
• Diagnosis of idiopathic or degenerative scoliosis with ≥30 ° Cobb curve

You may not qualify if:

• Previous spinal surgery
• Previous and relevant illnesses, surgery or trauma

Sponsors & Collaborators

• Istituto Scientifico Italiano Colonna Vertebrale: lead

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 19, 2022
• Study Start: March 31, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)