Kyphosis in Depressed or Anxious Patients Clinical Trial
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.
| Status | Terminated |
| Enrollment | 205 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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) |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Dr SCHULLER Sébastien | Service de Chirurgie du Rachis, HUS | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | sagittal balance of the spine : - kyphosis in depressed or anxious patients- lordosis in patients with manic | 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. | 2 hours | No |
| Secondary | link between the psychopathological profile and questionnaires | The secondary endpoints are finding a link between the psychopathological profile of patients using self-administered questionnaires. | 2 hours | No |