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Clinical Trials in Italy / NCT06779240
Active, not recruiting Observational

Distinguishing Non-Specific Low Back Pain from Scoliosis-Related Pain Via Quality of Life Questionnaires

NCT06779240 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Scientifico Italiano Colonna Vertebrale
Phase
Observational
Started
2025-01-07
Last updated
2025-01-16

Condition(s) studied

Idiopathic ScoliosisDegenerative Scoliosis

Investigational drug(s) / intervention(s)

Quality of life questionnaires

Quality of life questionnaires: 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 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 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Questionnaires comparison — 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.

Trial sites (1)

FacilityCityRegionStatus
ISICO Milan Italy

More Istituto Scientifico Italiano Colonna Vertebrale trials in Italy

Assessment of Trunk Aesthetics: Development of a New Tool Active, not recruiting
Impact of Spinal Curves on Asymmetric Posture in Idiopathic Scoliosis Active, not recruiting
Development and Internal Validation of Predicting Models of Idiopathic Scoliosis Natural History and Treatment Outcomes Through the Use of Artificial Intelligence in a Large Clinical Database Active, not recruiting
Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06779240 on ClinicalTrials.gov ↗ ← All trials in Italy