Clinical trial NCT01323127: Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
Official title: Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Low Back Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: % variation in the pelvic incidence angle in sitting compared to standing
timeFrame: Upon xray; day 1
Secondary outcomes:
measure: % variation in the sacral slope angle in sitting compared to standing
timeFrame: upon xray; Day 1
measure: % variation in the pelvic tilt angle in sitting compared to standing
timeFrame: upon xray; Day 1
measure: % variation in the lumbar lardosis angle in sitting compared to standing
timeFrame: upon xray; Day 1
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.