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

NCT06779240 | Active Not Recruiting

• 1 other identifier: LBP-Scoliosis
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Idiopathic Scoliosis; Degenerative Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Study Arms (2)

Scoliosis patients

Patients with a diagnosis of idiopathic scoliosis or degenerative scoliosis

Other: Quality of life questionnaires

Non specific LBP

Patients with non specific low back pain

Other: Quality of life questionnaires

Interventions

Quality of life questionnaires OTHER

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

Non specific LBP; Scoliosis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with LBP or scoliosis accessing a tertiary referral outpatient clinic specialized in the conservative treatment of spinal deformities

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Scientifico Italiano Colonna Vertebrale: lead

Study Sites (1)

ISICO

Milan, Italy, 20141, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 16, 2025
• Study Start: January 7, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

IT (1)