Kyphosis in Depressed or Anxious PatientsNCT02166775
Correlation Between Sagittal Balance of the Spine and Psychopathological Profile
An observational study of Kyphosis in Depressed or Anxious Patients and Lordosis in Patients With Manic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kyphosis in Depressed or Anxious Patients, Lordosis in Patients With Manic
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kyphosis in Depressed or Anxious Patients - Lordosis in Patients With Manic
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Dr SCHULLER Sébastien
Service de Chirurgie Du Rachis, HUS, Strasbourg
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (1)
link between the psychopathological profile and questionnaires
The secondary endpoints are finding a link between the psychopathological profile of patients using self-administered questionnaires.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Departure of psychologist in charge of questionnaires and scales administered to patients as part of the evaluation of primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kyphosis in Depressed or Anxious PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien SCHULLER, MD, Principal investigator, Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de StrasbourgYann Philippe CHARLES, MD, Study chair, Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166775
- Sponsor's protocol ID
- 5541
- Status last verified
- Apr 2016
- First submitted
- 14 Jun 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Sagittal Balance of the Spine and Psychopathological Profile
- ClinicalTrials.gov ID
- NCT02166775
- Acronym / sponsor ID
- 5541
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Departure of psychologist in charge of questionnaires and scales administered to patients as part of the evaluation of primary endpoint
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Jun 2014 (estimated)
- 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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kyphosis in Depressed or Anxious Patients - Lordosis in Patients With Manic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
link between the psychopathological profile and questionnaires
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: Departure of psychologist in charge of questionnaires and scales administered to patients as part of the evaluation of primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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. This study is not recruiting at the moment.
Sébastien SCHULLER, MD principal investigator
Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de Strasbourg
Yann Philippe CHARLES, MD study chair
Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kyphosis in Depressed or Anxious Patients and Lordosis in Patients With Manic, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Departure of psychologist in charge of questionnaires and scales administered to patients as part of the evaluation of primary endpoint). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sagittal balance of the spine : - kyphosis in depressed or anxious patients- lordosis in patients with manic (time frame: 2 hours). 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 5 Apr 2016.