Assessing the Quality of Life in Adults With Spinal Deformity

NCT ID: NCT05333757

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-05-30

Brief Summary

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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

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Conditions

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Scoliosis Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Questionnaire

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Scientifico Italiano Colonna Vertebrale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ISICO

Milan, Mi, Italy

Site Status

Countries

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Italy

Other Identifiers

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A-ISYQOL

Identifier Type: -

Identifier Source: org_study_id

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