Healthy SpinePSYPOS 2NCT07024121
Assessing the Socio-Psychological Determinants of Sagittal Balance
A study testing Patient consulting in spine surgery in people with Healthy Spine and Posture, run by University Hospital, Bordeaux.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Spine, Posture, Sagittal Balance
- What is being tested?
- Patient consulting in spine surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
William GERBEAUX contact
About this study
Official title: Assessing the Socio-Psychological Determinants of Sagittal Balance - PSYPOS2
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.
Read the 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.
- 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.
- Conditions
- Healthy Spine, Posture, Sagittal Balance, Socio-Psychological Factors
- Being tested
- Patient consulting in spine surgery
- Keywords
- Sagittal Balance, Socio-Psychological Factors, Postural Alignment, EOS Radiography, Orthopaedic Surgery, Healthy Spine, Spinal Function, Psychological Dimensions, Spinal Radiographs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient consulting in spine surgeryDiagnostic test
Self-administered questionnaire quality of life scales
| Study group | Role | What they receive |
|---|---|---|
| Patient consulting in spine surgery | Experimental | Patient consulting in spine surgery who have undergone or will undergo an EOS X-ray as part of their care pathway (particularly as part of a pre-operative assessment for hip arthroplasty) : Receives: Diagnostic Test: Patient consulting in spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Global Tilt and socio-psychological variables
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
Measured: Baseline
Secondary outcomes (8)
Correlation between sagittal balance and BBQ questionnaire
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.
Measured: Baseline
Correlation between sagittal balance and SF-36
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).
Measured: Baseline
Relation between sagittal balance and demographic variables
Relation between other parameters of sagittal balance and measured demographic variables (age, sex, weight, size, diplomas, profession, ...)
Measured: Baseline
Correlation between sagittal balance and TSK questionnaire
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..
Measured: Baseline
Correlation between sagittal balance and PCS questionnaire
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.
Measured: Baseline
Correlation between sagittal balance and HADS questionnaire
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.
Measured: Baseline
Correlation between sagittal balance and MSPQ questionnaire
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.
Measured: Baseline
Correlation between sagittal balance and Big Five Inventory questionnaire
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SpineStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin BOUYER, PROF, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024121
- Sponsor's protocol ID
- CHUBX 2023/59
- Acronym
- PSYPOS 2
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Socio-Psychological Determinants of Sagittal Balance - PSYPOS2
- ClinicalTrials.gov ID
- NCT07024121
- Acronym / sponsor ID
- PSYPOS 2 / CHUBX 2023/59
- Conditions
- Healthy Spine, Posture, Sagittal Balance, Socio-Psychological Factors
- Keywords
- Sagittal Balance, Socio-Psychological Factors, Postural Alignment, EOS Radiography, Orthopaedic Surgery, Healthy Spine, Spinal Function, Psychological Dimensions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient consulting in spine surgery | Experimental | Diagnostic Test: Patient consulting in spine surgeryPatient consulting in spine surgery who have undergone or will undergo an EOS X-ray as part of their care pathway (particularly as part of a pre-operative assessment for hip arthroplasty) : |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- Spinal fusion at any operated level,
- Active or non-active spinal infection at any level,
- Spinal fracture at any level,
- Spinal deformity:
- History of Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient consulting in spine surgerySelf-administered questionnaire quality of life scales | Diagnostic test | Patient consulting in spine surgery |
Primary outcome
Correlation between Global Tilt and socio-psychological variables
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William GERBEAUX contact
Benjamin BOUYER, PROF principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
A study testing Patient consulting in spine surgery in people with Healthy Spine and Posture, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin BOUYER, PROF (+335 56 79 87 18, b.bouyer@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Global Tilt and socio-psychological variables (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.