Clinical Trial

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

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Record status
This record was last updated January 16, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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).
Trial Details
NCT Number NCT06779240
Lead Sponsor Istituto Scientifico Italiano Colonna Vertebrale
Conditions Idiopathic Scoliosis, Degenerative Scoliosis
Enrollment 225 participants
Start Date 2025-01-07
Primary Completion 2026-01 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-16