Health TrialsbyHealthPanel

Assessing the Socio-Psychological Determinants of Sagittal Balance

ConditionsHealthy SpinePostureSagittal BalanceSocio-Psychological Factors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Spinal fusion at any operated level,

Active or non-active spinal infection at any level,

Spinal fracture at any level,

Scheuermann's disease (at least 3 adjacent vertebrae with wedge deformity and kyphosis increased by 5 degrees),

Trial design

Design model

Single group

Treatments tested in this trial

  • Patient consulting in spine surgery

    Diagnostic test

    Self-administered questionnaire quality of life scales

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patient consulting in spine surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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).

Time frame
Baseline
3

Relation between sagittal balance and demographic variables

Relation between other parameters of sagittal balance and measured demographic variables (age, sex, weight, size, diplomas, profession, ...)

Time frame
Baseline
4

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..

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: