ClinicalTrials.gov
ClinicalTrials.gov Menu

Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01323127
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

March 24, 2011
March 25, 2011
March 26, 2015
April 2011
December 2011   (Final data collection date for primary outcome measure)
% variation in the pelvic incidence angle in sitting compared to standing [ Time Frame: Upon xray; day 1 ]
Same as current
Complete list of historical versions of study NCT01323127 on ClinicalTrials.gov Archive Site
  • % 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 ]
Same as current
Not Provided
Not Provided
 
Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Two populations are compared: one with chronic back pain, and the other a group of hospitalized patients with no lombo-peliven complications.
  • Back Pain
  • Low Back Pain
Procedure: Sagital xrays
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.
  • Chronic back pain
    This group of patients has had chronic back pain for longer than 3 months.
    Intervention: 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.
    Intervention: Procedure: Sagital xrays
Vaucher M, Isner-Horobeti ME, Demattei C, Alonso S, Hérisson C, Kouyoumdjian P, van Dieën 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01323127
LOCAL/2010/AD-03
2010-A01536-33 ( Other Identifier: RCB number )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Arnaud Dupeyron, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2015