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临床试验/NCT06779240
NCT06779240进行中(未招募)不适用

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

Istituto Scientifico Italiano Colonna Vertebrale1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2025年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
225
试验地点
1
主要终点
Questionnaires comparison

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Questionnaires comparison

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istituto Scientifico Italiano Colonna Vertebrale
申办方类型
Other
责任方
Sponsor

研究点 (1)

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