- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01323127
Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
November 14, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
The main objective of this study is to investigate the influence of seat type (straight chair versus "ergonomic" chair) on the sagittal alignment of the lumbo-pelvic complex in two different postures compared to standing for each individual in both a chronic-back-pain and a non-chronic-back-pain population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
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
-
-
Gard
-
Nîmes, Gard, France, 30029
- Centre Hospitalier Universitaire de Nīmes
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Two populations are compared: one with chronic back pain, and the other a group of hospitalized patients with no lombo-peliven complications.
Description
General Inclusion Criteria:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
Inclusion Criteria for the Chronic Back Pain Group
- Patient has chronic lombalgia (> 3 months)
- Patient has discopathy evidenced by standard imaging of the lumbar spine
Inclusion Criteria for the Non Chronic Back Pain Group
- Patient does not have chronic lombalgia or neurological symptoms
- Patients hospitalized for cardiovascular physical therapy which does not interfere with the sagital alignment of the lombo-pelivien complex (post-infarctus care, cardiac insufficiency)
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The subject has had more than two x-rays, or similar ray exposure during the previous year
- The subject has a professional activity or hobby that exposes him/her to radiation
- The subject has a lombo-pelivien malformation
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chronic back pain
This group of patients has had chronic back pain for longer than 3 months.
|
5 xrays will be taken: (1) Upright standing position; (2) Upright, straight chair position; (3) Slouching, straight chair position; (4) Upright, ergonomic chair position; (5) Slouching, ergonomic chair position.
|
|
Non chronic back pain
This group of patients is hospitalized for cardio physical therapy, and has no lumbar-pelvic complications.
Patients are selected from the hospitalized population according to age, sex, and BMI in order to match chronic back pain patients.
|
5 xrays will be taken: (1) Upright standing position; (2) Upright, straight chair position; (3) Slouching, straight chair position; (4) Upright, ergonomic chair position; (5) Slouching, ergonomic chair position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
% variation in the pelvic incidence angle in sitting compared to standing
Time Frame: Upon xray; day 1
|
Upon xray; day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
% variation in the sacral slope angle in sitting compared to standing
Time Frame: upon xray; Day 1
|
upon xray; Day 1
|
|
% variation in the pelvic tilt angle in sitting compared to standing
Time Frame: upon xray; Day 1
|
upon xray; Day 1
|
|
% variation in the lumbar lardosis angle in sitting compared to standing
Time Frame: upon xray; Day 1
|
upon xray; Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arnaud Dupeyron, MD PhD, Centre Hospitalier Universitaire de Nīmes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2011
Primary Completion (Actual)
December 10, 2011
Study Completion (Actual)
December 10, 2011
Study Registration Dates
First Submitted
March 24, 2011
First Submitted That Met QC Criteria
March 24, 2011
First Posted (Estimated)
March 25, 2011
Study Record Updates
Last Update Posted (Estimated)
November 17, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2010/AD-03
- 2010-A01536-33 (Other Identifier: ANSM)
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.
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