Skip to content

Assessing the Quality of Life in Adults With Spinal Deformity

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05333757
Enrollment
150
Registered
2022-04-19
Start date
2022-03-31
Completion date
2023-05-30
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Scoliosis

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.

Interventions

OTHERQuestionnaire

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

Sponsors

Istituto Scientifico Italiano Colonna Vertebrale
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Statistical properties of SRS-22 and ISYQOL questionnairethrough study completion, an average of 1 yearThe 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026