Patient consulting in spine surgery
Diagnostic TestSelf-administered questionnaire quality of life scales
NCT Number: NCT07024121
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Self-administered questionnaire quality of life scales
Time frame: 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
Time frame: Baseline
Correlation between other parameters of sagittal balance (T1-pelvic angle, T1 slope, LL, PT, SVA) and various psychological dimensions studied per the BBQ questionnaire BBQ : Back Belief Questionnaire : Relatively easy to implement (14 questions, ranging from 0 to 5) The Back and Belief Questionnaire (BBQ) is a standardized questionnaire with 14 items that allows for a score to be established on the extent of false beliefs held by subjects.
Time frame: Baseline
Correlation between other parameters of sagittal balance (T1-pelvic angle, T1 slope, LL, PT, SVA) and perceived health parameters (SF-36) SF-36v2® Health Survey : Benchmark score, validated by the scientific community.
36 items divided into 8 dimensions. Quick (less than 10 minutes).
Time frame: Baseline
Relation between other parameters of sagittal balance and measured demographic variables (age, sex, weight, size, diplomas, profession, ...)
Time frame: Baseline
Correlation between other parameters of sagittal balance (T1-pelvic angle, T1 slope, LL, PT, SVA) and various psychological dimensions studied per the TSK questionnaire TSK : Tampa Scale of Kinesiophobia : Validated for low back pain and in French.
Relatively easy to implement (17 questions, the patient must respond by choosing a number between 1 (strongly disagree) and 4 (strongly agree).
A score above 40 indicates a patient with significant kinesiophobia..
Time frame: Baseline
Correlation between other parameters of sagittal balance (T1-pelvic angle, T1 slope, LL, PT, SVA) and various psychological dimensions studied per the PCS questionnaire
The Catastrophism Pain Catastrophising Scale (PCS) considers both catastrophizing thoughts and behaviors, described as a catastrophizing of pain.
Validated in low back pain. Easy to implement (13 questions, with scores ranging from 0 to 4). Adapted into French using the PCS-CF. A score > 30 indicates a high level of catastrophizing.
Time frame: Baseline
Correlation between other parameters of sagittal balance (T1-pelvic angle, T1 slope, LL, PT, SVA) and various psychological dimensions studied per the HADS questionnaire Hospital Anxiety and Depression Scale (HADS) questionnaire is Easy to implement (14 questions, divided between questions on anxiety and depression).
Good internal consistency in spinal pathology Validated in French A score ≥ 11 indicates the presence of anxiety or depressive symptoms.
Time frame: Baseline
Correlation between other parameters of sagittal balance (T1-pelvic angle, T1 slope, LL, PT, SVA) and various psychological dimensions studied per the MSPQ questionnaire Modified Somatic Perception Questionnaire (MSPQ) questionnaire is Easy to implement (13 questions, ranging from 0 to 3 points) Validated in spinal pathologies. The threshold has not been validated. We will use Balansyan's study as a guide, which determined that a score above 18 points appears appropriate for identifying somatic symptoms.
This threshold has a sensitivity of 29% with very few false positives.
Time frame: Baseline
Correlation between other parameters of sagittal balance (T1-pelvic angle, T1 slope, LL, PT, SVA) and various psychological dimensions studied per the Big Five Inventory questionnaire Big Five Inventory - 10-questions short form is Easy to implement (10 questions).
Short form of the Big Five Inventory validated in French. Reproducible and validated tool. Describes patients according to 5 categories: Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness.
The score provides percentages for each category, indicating the patient's strengths and weaknesses.
Contact information is provided by the study sponsor or research team.
Benjamin BOUYER, PROF
CONTACT
William GERBEAUX
CONTACT
University Hospital, Bordeaux
Other
Assessing the Socio-Psychological Determinants of Sagittal Balance - PSYPOS2
Acronym: PSYPOS 2
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.
Published trials that share one or more normalized conditions with this study.
NCT07327814
Brain Diseases, Cardiovascular Diseases
Beirut, Lebanon
View Trial DetailsNCT07445100
Behavior, Behavioral Symptoms
View Trial DetailsNCT07006363
Cervical Pain, Posterior, Musculoskeletal Disorder of the Neck
Sivas, Turkey (Türkiye)
View Trial DetailsNCT06938958
Ergonomics, Musculoskeletal Strain
Plymouth, Devon, United Kingdom
View Trial Details