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NCT Number: NCT06779240

Distinguishing Non-Specific Low Back Pain from Scoliosis-Related Pain Via 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).

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ISICO

Milan, Italy, 20141

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istituto Scientifico Italiano Colonna Vertebrale

Other

Registry information

Official study title

Non-specific Low Back Pain and Low Back Pain Secondary to Scoliosis: is It Possible to Differentiate Them Through Quality of Life Questionnaires?

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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