Correlation Between Sagittal Balance of the Spine and Psychopathological Profile

April 4, 2016 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Strasbourg
      • Service de Chirurgie du Rachis, HUS, Strasbourg, France
        • Dr SCHULLER Sébastien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kyphosis in Depressed or Anxious Patients - Lordosis in Patients With Manic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sagittal balance of the spine : - kyphosis in depressed or anxious patients- lordosis in patients with manic
Time Frame: 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.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
link between the psychopathological profile and questionnaires
Time Frame: 2 hours
The secondary endpoints are finding a link between the psychopathological profile of patients using self-administered questionnaires.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Sébastien SCHULLER, MD, Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de Strasbourg
  • Study Chair: Yann Philippe CHARLES, MD, Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 14, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kyphosis in Depressed or Anxious Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe