NCT01323127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2011

Completed
Last Updated

November 17, 2025

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

March 24, 2011

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • % variation in the pelvic incidence angle in sitting compared to standing

    Upon xray; day 1

Secondary Outcomes (3)

  • % variation in the sacral slope angle in sitting compared to standing

    upon xray; Day 1

  • % variation in the pelvic tilt angle in sitting compared to standing

    upon xray; Day 1

  • % variation in the lumbar lardosis angle in sitting compared to standing

    upon xray; Day 1

Study Arms (2)

Chronic back pain

This group of patients has had chronic back pain for longer than 3 months.

Procedure: Sagital xrays

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

Interventions

Sagital xraysPROCEDURE

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.

Chronic back painNon chronic back pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Patient has chronic lombalgia (\> 3 months)
  • Patient has discopathy evidenced by standard imaging of the lumbar spine
  • 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)

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Back PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arnaud Dupeyron, MD PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

April 1, 2011

Primary Completion

December 10, 2011

Study Completion

December 10, 2011

Last Updated

November 17, 2025

Record last verified: 2015-03

Locations