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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323127
• Other study ID #: LOCAL/2010/AD-03
• Secondary ID: 2010-A01536-33
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: March 25, 2015
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% variation in the pelvic incidence angle in sitting compared to standing		Upon xray; day 1	No
Secondary	% variation in the sacral slope angle in sitting compared to standing		upon xray; Day 1	No
Secondary	% variation in the pelvic tilt angle in sitting compared to standing		upon xray; Day 1	No
Secondary	% variation in the lumbar lardosis angle in sitting compared to standing		upon xray; Day 1	No