Assessing the Socio-Psychological Determinants of Sagittal Balance - PSYPOS2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Correlation between Global Tilt and socio-psychological variables
研究概览
简要总结
The research focuses on describing the association between socio-psychological factors, collected through standardized self-questionnaires, and the postural alignment of patients without spinal pathology consulting in the orthopaedic surgery department, as evaluated on EOS® radiographic images. This mono-centric, analytical, non-interventional, cross-sectional epidemiological study has for primary outcome to explore the relationship between socio-psychological factors and posture in patients with a healthy spine.
详细描述
- This study investigates the association between socio-psychological factors, collected through standardized self-questionnaires, and the postural alignment of patients without spinal pathology consulting in the orthopaedic surgery department, as evaluated on EOS® radiographic images. This mono-centric, analytical, non-interventional, cross-sectional epidemiological study has for primary outcome to explore the relationship between socio-psychological factors and posture in patients with a healthy spine.
- Posture, or sagittal balance, is a key aspect of spinal function. Considering sagittal balance is essential because its alteration leads to a decrease in quality of life and can quickly become a source of disability. Its analysis is conducted using defined parameters on spinal radiographs and is crucial for understanding spinal pathologies. Links between low back pain and posture have already been clearly reported, as well as between low back pain and socio-psychological factors. There is also evidence in the literature suggesting a relationship between socio-psychological factors and sagittal balance but these data are rare and fragmented, even though this association could be particularly pronounced in patients with spinal pathologies requiring surgical intervention.
However, it seems worthwhile to investigate this association between posture and socio-psychological characteristics in patients without spinal pathology to understand the link with other confounding or intermediate factors.
Furthermore, this association could be responsible for some of the variability in clinical and radiological outcomes of treatments, particularly surgical ones, with the presence of poor postoperative clinical outcomes despite adequate restoration of sagittal balance.
o This analytical, non-interventional study requires only one scheduled consultation within the care pathway of patients without spinal pathology consulting in the orthopaedic surgery department of the University Hospital of Bordeaux and undergoing EOS radiography as part of their care pathway. During this consultation, radiographic data and questionnaire responses will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient aged ≥ 18 years
- •Patient consulting at the investigational center (orthopaedic surgery department of Bordeaux University Hospital) who has undergone or will undergo an EOS® radiography as part of their treatment pathway (particularly in the context of a preoperative assessment for hip arthroplasty).
- •Affiliation with a medical insurance scheme under the French National Health Insurance.
排除标准
- •Spinal fusion at any operated level,
- •Active or non-active spinal infection at any level,
- •Spinal fracture at any level,
- •Spinal deformity:
- •Scheuermann's disease (at least 3 adjacent vertebrae with wedge deformity and kyphosis increased by 5 degrees),
- •Scoliosis (Cobb angle > 10 degrees and vertebral rotation).
- •History of Parkinson's disease
- •Active cancer or hematologic disorder with bone involvement
- •Any condition preventing the ability to respond to questionnaires with discernment
- •Neurological deficit requiring urgent surgical intervention
- •Hyperalgesic condition requiring urgent surgical intervention
- •Polytrauma with organ failure
- •Patient unable to understand study-related information
- •Patient under guardianship or curatorship,
- •Persons deprived of liberty by judicial or administrative decision,
- •Persons receiving psychiatric care under constraint,
- •Persons under guardianship,
- •Patient not affiliated with a social protection scheme
结局指标
主要结局
Correlation between Global Tilt and socio-psychological variables
时间窗: Baseline
The relationship between sagittal balance, assessed using EOS® imaging and measured by the angle known as Global Tilt (GT), and socio-psychological variables . Sagittal balance is normal if the Global Tilt angle is less than 23.2 degrees. When the Global Tilt angle is more than 33.7 degrees, it is considered that there is a moderate pathological imbalance of the sagittal balance
次要结局
- Correlation between sagittal balance and BBQ questionnaire(Baseline)
- Correlation between sagittal balance and SF-36(Baseline)
- Relation between sagittal balance and demographic variables(Baseline)
- Correlation between sagittal balance and TSK questionnaire(Baseline)
- Correlation between sagittal balance and PCS questionnaire(Baseline)
- Correlation between sagittal balance and HADS questionnaire(Baseline)
- Correlation between sagittal balance and MSPQ questionnaire(Baseline)
- Correlation between sagittal balance and Big Five Inventory questionnaire(Baseline)