Back PainNCT01323127
Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
An observational study of Back Pain and Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Low Back Pain
- What is being tested?
- Sagital xrays
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to 10 Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two populations are compared: one with chronic back pain, and the other a group of hospitalized patients with no lombo-peliven complications.
Who may be able to join
- Patient has chronic lombalgia (> 3 months)
- Patient has discopathy evidenced by standard imaging of the lumbar spine
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Back Pain, Low Back Pain
- Being tested
- Sagital xrays
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagital xraysProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic back pain | This group of patients has had chronic back pain for longer than 3 months. Receives: Procedure: Sagital xrays | |
| 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. Receives: Procedure: Sagital xrays |
What is being measured
The primary outcome is the main question the study is designed to answer.
% variation in the pelvic incidence angle in sitting compared to standing
Measured: Upon xray; day 1
Secondary outcomes (3)
% variation in the sacral slope angle in sitting compared to standing
Measured: upon xray; Day 1
% variation in the pelvic tilt angle in sitting compared to standing
Measured: upon xray; Day 1
% variation in the lumbar lardosis angle in sitting compared to standing
Measured: upon xray; Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startApr 2011
- Primary completion10 Dec 2011
- Study completion10 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dupeyron, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323127
- Sponsor's protocol ID
- LOCAL/2010/AD-03
- Other IDs
- 2010-A01536-33
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2011
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Vaucher M, Isner-Horobeti ME, Demattei C, Alonso S, Herisson C, Kouyoumdjian P, van Dieen JH, Dupeyron A. Effect of a kneeling chair on lumbar curvature in patients with low back pain and healthy controls: A pilot study. Ann Phys Rehabil Med. 2015 Jun;58(3):151-6. doi: 10.1016/j.rehab.2015.01.003. Epub 2015 May 5.
PubMed 25956202
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
- ClinicalTrials.gov ID
- NCT01323127
- Acronym / sponsor ID
- LOCAL/2010/AD-03
- Conditions
- Back Pain, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- 10 Dec 2011 (actual)
- Study completion
- 10 Dec 2011 (actual)
- First posted
- 25 Mar 2011 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic back pain | – | Procedure: Sagital xraysThis group of patients has had chronic back pain for longer than 3 months. |
| Non chronic back pain | – | Procedure: Sagital xraysThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two populations are compared: one with chronic back pain, and the other a group of hospitalized patients with no lombo-peliven complications.
Key inclusion criteria (4 listed)
- Patient has chronic lombalgia (> 3 months)
- Patient has discopathy evidenced by standard imaging of the lumbar spine
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sagital xrays5 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. | Procedure or surgery | Chronic back pain, Non chronic back pain |
Primary outcome
% variation in the pelvic incidence angle in sitting compared to standing
Time frame: Upon xray; day 1
3 secondary outcomes
% variation in the sacral slope angle in sitting compared to standing
Time frame: upon xray; Day 1
% variation in the pelvic tilt angle in sitting compared to standing
Time frame: upon xray; Day 1
% variation in the lumbar lardosis angle in sitting compared to standing
Time frame: upon xray; Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 25956202Vaucher M, Isner-Horobeti ME, Demattei C, Alonso S, Herisson C, Kouyoumdjian P, van Dieen JH, Dupeyron A. Effect of a kneeling chair on lumbar curvature in patients with low back pain and healthy controls: A pilot study. Ann Phys Rehabil Med. 2015 Jun;58(3):151-6. doi: 10.1016/j.rehab.2015.01.003. Epub 2015 May 5.
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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.
Arnaud Dupeyron, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Back Pain and Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 17 Nov 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% variation in the pelvic incidence angle in sitting compared to standing (time frame: Upon xray; day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01323127, which also lists 1 linked publication.
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 17 Nov 2025.