Assessing the Socio-Psychological Determinants of Sagittal Balance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient consulting in spine surgery.
- Who it may be relevant to
- Registry conditions: Healthy Spine, Posture, Sagittal Balance, Socio-Psychological Factors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Socio-Psychological Determinants of Sagittal Balance - PSYPOS2
Overview
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.
Detailed description
* 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.
Interventions
- Diagnostic test Patient consulting in spine surgery
Self-administered questionnaire quality of life scales
Primary outcome measures
- Correlation between Global Tilt and socio-psychological variables [Time frame: Baseline]
Secondary outcome measures (8)
- Correlation between sagittal balance and BBQ questionnaire [Time frame: Baseline]
- Correlation between sagittal balance and SF-36 [Time frame: Baseline]
- Relation between sagittal balance and demographic variables [Time frame: Baseline]
- Correlation between sagittal balance and TSK questionnaire [Time frame: Baseline]
- Correlation between sagittal balance and PCS questionnaire [Time frame: Baseline]
- Correlation between sagittal balance and HADS questionnaire [Time frame: Baseline]
- Correlation between sagittal balance and MSPQ questionnaire [Time frame: Baseline]
- Correlation between sagittal balance and Big Five Inventory questionnaire [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07024121 · CHUBX 2023/59