Correlation Between Sagittal Balance of the Spine and Psychopathological Profile

Terminated

• Conditions: Kyphosis in Depressed or Anxious Patients; Lordosis in Patients With Manic

• Registration Number: NCT02166775
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

In this trial, the correlation between the psychopathological profile and sagittal balance unexplored to date spine will be studied. Indeed, a number of patients who benefited from well-conducted surgical treatment, targeted and tailored to their pathology, respond poorly to it. The investigators wonder if there are biomechanical factors or factors of psychopathological order which might influence the effectiveness of treatment. This seems logical for the entire medical community, but it has never been demonstrated in a clinical trial.

Detailed Description

The purpose of this study is to find a global diagnostic and standardized tool , easy to use, on psychopathological factors influencing the posture of the patients lombalgia so that in this will be used to use identify upstream surgery, the patients undergoing psychiatric treatment of mood rather than surgical treatment. And thus may economise a surgical operation and its complications and the related expenses.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-14
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-18
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Men and women aged 18 to 70 years ·
• Spine surgery outpatients with or without low back pain with radicular ·- Affiliated to a social security scheme,
• Having signed an informed consent and were informed of the results of the consultation prior to inclusion

Exclusion Criteria

• Patients having the major diseases of the spine: deformities (scoliosis, kyphosis), tumors, fractures, inflammatory and metabolic ·
• Patients having a spinal surgery history ·
• Patients difficult to inform ( emergency ward patients, patients with difficulties in oral comprehension)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sagittal balance of the spine : - kyphosis in depressed or anxious patients- lordosis in patients with manic	2 hours	The primary endpoint was to compare the L1S1 lordosis measured in degrees relative to L1S1 lordosis expected, i-e the pelvic tilt +/- 10 ° and analyzed in relation to anxiety scores given by the Scale Hamilton Anxiety (HAM-A), depression with the Hamilton depression Scale (HAM-D) and hypomania using the Young Mania Rating Scale (YMRS). regarding the HAM-A, greater than or equal to 17 score will be considered as indicative of anxiety. For the HAM-D greater than or equal to 13 score will be considered indicative of depression. For the YMRS, greater than or equal to 20 score will be considered as indicative of a manic syndrome. It is obvious that the higher the score, the higher the importance of the disorder will be.

Secondary Outcome Measures

Name	Time	Method
link between the psychopathological profile and questionnaires	2 hours	The secondary endpoints are finding a link between the psychopathological profile of patients using self-administered questionnaires.

Trial Locations

Locations (1)

Dr SCHULLER Sébastien; 🇫🇷 Service de Chirurgie du Rachis, HUS, Strasbourg, France

Dr SCHULLER Sébastien

🇫🇷Service de Chirurgie du Rachis, HUS, Strasbourg, France