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OpenTrials
Completed

NCT Number: NCT05333757

Assessing the Quality of Life in Adults With Spinal Deformity

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Quality of Life Spinal Curvatures Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ISICO

Milan, Mi, 20141, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. Statistical properties of SRS-22 and ISYQOL questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Scientifico Italiano Colonna Vertebrale

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2022
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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