Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01323127
First received: March 24, 2011
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Back Pain
Low Back Pain
 Procedure: Sagital xrays

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position

Resource links provided by NLM:

MedlinePlus related topics: Back Pain X-Rays
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • % variation in the pelvic incidence angle in sitting compared to standing [ Time Frame: Upon xray; day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % variation in the sacral slope angle in sitting compared to standing [ Time Frame: upon xray; Day 1 ] [ Designated as safety issue: No ]
  • % variation in the pelvic tilt angle in sitting compared to standing [ Time Frame: upon xray; Day 1 ] [ Designated as safety issue: No ]
  • % variation in the lumbar lardosis angle in sitting compared to standing [ Time Frame: upon xray; Day 1 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic back pain
This group of patients has had chronic back pain for longer than 3 months.
 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.
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323127

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Arnaud Dupeyron, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01323127     History of Changes
Other Study ID Numbers: LOCAL/2010/AD-03, 2010-A01536-33
Study First Received: March 24, 2011
Last Updated: March 22, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013