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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT01323127
• Date of registration: 24/03/2011
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
• Scientific title: Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position
• Date of first enrolment: April 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01323127
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Arnaud Dupeyron, MD PhD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Back Pain

Low Back Pain

Intervention(s)

Procedure: Sagital xrays

Primary Outcome(s)

% variation in the pelvic incidence angle in sitting compared to standing [Time Frame: Upon xray; day 1]

Secondary Outcome(s)

% 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]

% variation in the sacral slope angle in sitting compared to standing [Time Frame: upon xray; Day 1]

Secondary ID(s)

LOCAL/2010/AD-03

2010-A01536-33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors