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 3, 2014
Last verified: March 2014
  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:


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 3, 2014
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 April 16, 2014