ScoliosisNCT05333757
Assessing the Quality of Life in Adults With Spinal Deformity
An observational study of Scoliosis and Quality of Life, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scoliosis, Quality of Life
- What is being tested?
- Questionnaire
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2022to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated conservatively for idiopathic scoliosis or undergoing clinical monitoring
Who may be able to join
- Age ≥ 18 years
- Diagnosis of idiopathic or degenerative scoliosis with ≥30 ° Cobb curve
Who cannot join
- Previous spinal surgery
- Previous and relevant illnesses, surgery or trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Quality of Life in Adults With Spinal Deformity: a Retrospective Comparison Between Two Questionnaires
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
- Being tested
- Questionnaire
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Adults with spinal deformities were asked to complete two questionnaires assessing quality of life
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start31 Mar 2022
- Primary completion30 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333757
- Sponsor's protocol ID
- A-ISYQOL
- Status last verified
- Jun 2023
- First submitted
- 1 Apr 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be uploaded to public repository
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Quality of Life in Adults With Spinal Deformity: a Retrospective Comparison Between Two Questionnaires
- ClinicalTrials.gov ID
- NCT05333757
- Acronym / sponsor ID
- A-ISYQOL
- Conditions
- Scoliosis, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life | – | Other: QuestionnaireAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated conservatively for idiopathic scoliosis or undergoing clinical monitoring
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Diagnosis of idiopathic or degenerative scoliosis with ≥30 ° Cobb curve
Key exclusion criteria (2 listed)
- Previous spinal surgery
- Previous and relevant illnesses, surgery or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAdults with spinal deformities were asked to complete two questionnaires assessing quality of life | Other | Quality of life |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Yes. Raw data will be uploaded to public repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Quality of Life, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical properties of SRS-22 and ISYQOL questionnaire (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.