Idiopathic ScoliosisNCT06779240
Distinguishing Non-Specific Low Back Pain from Scoliosis-Related Pain Via Quality of Life Questionnaires
An observational study of Idiopathic Scoliosis and Degenerative Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
Vertebral deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools have been developed to investigate the extent of this impact; the SRS-22 (Scoliosis Research Society) questionnaire is the most commonly used instrument for assessing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Scoliosis, Degenerative Scoliosis
- What is being tested?
- Quality of life questionnaires
- How many people
- 225 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with LBP or scoliosis accessing a tertiary referral outpatient clinic specialized in the conservative treatment of spinal deformities
Who may be able to join
- Age ≥ 18 years
- Diagnosis of idiopathic or degenerative scoliosis with a curve >10° Cobb and
- low back pain
- Diagnosis of non-specific low back pain
Who cannot join
- Previous spinal surgery
- Significant past illnesses, surgeries, or trauma
- Secondary scoliosis
- Other deformities such as spondylolisthesis and spinal canal stenosis
- Incomplete ODI and SRS-22 data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-specific Low Back Pain and Low Back Pain Secondary to Scoliosis: is It Possible to Differentiate Them Through Quality of Life Questionnaires?
Vertebral deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools have been developed to investigate the extent of this impact; the SRS-22 (Scoliosis Research Society) questionnaire is the most commonly used instrument for assessing quality of life (QoL) in patients with idiopathic scoliosis. The Oswestry Disability Index (ODI), on the other hand, was developed to evaluate the quality of life in adult patients with chronic non-specific low back pain.
The clinical protocols at our institute involve the regular and continuous evaluation of the quality of life in patients undergoing treatment and monitoring for scoliosis and other vertebral deformities. To this end, the SRS-22 questionnaire and the ODI questionnaire are employed, along with other measures such as the COMI (Core Outcome Measure Index) and ISYQoL (Italian Spine Youth Quality of Life).
The aim of this study is to compare the properties of the ODI with those of the SRS-22 questionnaire in adults, by analyzing differences between individuals with non-specific low back pain and those with scoliosis. The secondary objective involves a sub-analysis based on the severity of scoliosis, dividing curves into major (30° Cobb or higher) and minor (below 30° Cobb). Finally, if sufficient data are available, the study will also evaluate other commonly used questionnaires (COMI and ISYQoL).
- Conditions
- Idiopathic Scoliosis, Degenerative Scoliosis
- Being tested
- Quality of life questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesOther
The clinical protocols at our institute involve the regular and continuous evaluation of the quality of life in patients undergoing treatment and monitoring for scoliosis and other vertebral deformities. To this end, the SRS-22 (Scoliosis Research Society) questionnaire and the ODI (Oswestry Disability Index) questionnaire are employed, along with other measures such as the COMI (Core Outcome Measure Index) and ISYQoL (Italian Spine Youth Quality of Life) and administrated to every patients
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis patients | Patients with a diagnosis of idiopathic scoliosis or degenerative scoliosis Receives: Other: Quality of life questionnaires | |
| Non specific LBP | Patients with non specific low back pain Receives: Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires comparison
compare the properties of the Oswestry Disability Index (ODI) with those of the SRS-22 questionnaire in adults, specifically by analyzing differences between individuals with non-specific low back pain and those with scoliosis.
This comparison focuses on determining the effectiveness and applicability of these tools in assessing quality of life (QoL) in these two distinct patient populations.
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 posted16 Jan 2025
- Study start7 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- 225 participants (estimated)
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
- NCT06779240
- Sponsor's protocol ID
- LBP-Scoliosis
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-specific Low Back Pain and Low Back Pain Secondary to Scoliosis: is It Possible to Differentiate Them Through Quality of Life Questionnaires?
- ClinicalTrials.gov ID
- NCT06779240
- Acronym / sponsor ID
- LBP-Scoliosis
- Conditions
- Idiopathic Scoliosis, Degenerative Scoliosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 16 Jan 2025 (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.
Vertebral deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools have been developed to investigate the extent of this impact; the SRS-22 (Scoliosis Research Society) questionnaire is the most commonly used instrument for assessing quality of life (QoL) in patients with idiopathic scoliosis. The Oswestry Disability Index (ODI), on the other hand, was developed to evaluate the quality of life in adult patients with chronic non-specific low back pain.
The clinical protocols at our institute involve the regular and continuous evaluation of the quality of life in patients undergoing treatment and monitoring for scoliosis and other vertebral deformities. To this end, the SRS-22 questionnaire and the ODI questionnaire are employed, along with other measures such as the COMI (Core Outcome Measure Index) and ISYQoL (Italian Spine Youth Quality of Life).
The aim of this study is to compare the properties of the ODI with those of the SRS-22 questionnaire in adults, by analyzing differences between individuals with non-specific low back pain and those with scoliosis. The secondary objective involves a sub-analysis based on the severity of scoliosis, dividing curves into major (30° Cobb or higher) and minor (below 30° Cobb). Finally, if sufficient data are available, the study will also evaluate other commonly used questionnaires (COMI and ISYQoL).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis patients | – | Other: Quality of life questionnairesPatients with a diagnosis of idiopathic scoliosis or degenerative scoliosis |
| Non specific LBP | – | Other: Quality of life questionnairesPatients with non specific low back pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with LBP or scoliosis accessing a tertiary referral outpatient clinic specialized in the conservative treatment of spinal deformities
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of idiopathic or degenerative scoliosis with a curve >10° Cobb and
- low back pain
- Diagnosis of non-specific low back pain
Key exclusion criteria (5 listed)
- Previous spinal surgery
- Significant past illnesses, surgeries, or trauma
- Secondary scoliosis
- Other deformities such as spondylolisthesis and spinal canal stenosis
- Incomplete ODI and SRS-22 data
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 |
|---|---|---|
| Quality of life questionnairesThe clinical protocols at our institute involve the regular and continuous evaluation of the quality of life in patients undergoing treatment and monitoring for scoliosis and other vertebral deformities. To this end, the SRS-22 (Scoliosis Research Society) questionnaire and the ODI (Oswestry Disability Index) questionnaire are employed, along with other measures such as the COMI (Core Outcome Measure Index) and ISYQoL (Italian Spine Youth Quality of Life) and administrated to every patients | Other | Non specific LBP, Scoliosis patients |
Primary outcome
Questionnaires comparison
Time frame: through study completion, an average of 1 year
compare the properties of the Oswestry Disability Index (ODI) with those of the SRS-22 questionnaire in adults, specifically by analyzing differences between individuals with non-specific low back pain and those with scoliosis. This comparison focuses on determining the effectiveness and applicability of these tools in assessing quality of life (QoL) in these two distinct patient populations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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 Idiopathic Scoliosis and Degenerative Scoliosis, 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Questionnaires comparison (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 16 Jan 2025.