NCT01406743

Brief Summary

The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001). The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring. However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population. So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable healthy-volunteers

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

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 10, 2026

Status Verified

January 1, 2015

Enrollment Period

2.6 years

First QC Date

July 28, 2011

Last Update Submit

June 8, 2026

Conditions

Healthy Volunteers

Keywords

Spine and pelvis parametersSagittal balanceDatabase

Outcome Measures

Primary Outcomes (5)

  • the profile spine parameters: apex lumbar position

    1 day

  • the lordosis lower angle, back type according to the ROUSSOULY

    1 day

  • the sagittal balance parameters

    1 day

  • the lordosis upper angle, back type according to the ROUSSOULY

    1 day

  • the pelvis parameters

    1 day

Study Arms (1)

EOS™ Acquisition

EXPERIMENTAL
Device: EOS™ Acquisition

Interventions

EOS™ AcquisitionDEVICE

Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.

EOS™ Acquisition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of more than 18 years old
  • Both genders
  • Woman under efficient contraception (if not menopause)
  • EVA \< 2 for the rachis (lumbar vertebra and radiculaire),
  • Score ODI ≤ 20 %
  • Given informed consent
  • Subject with French health system

You may not qualify if:

  • Pregnant or feeding women
  • Subject having a follow-up of the back or a regular back pain,
  • Subject presenting lower limbs pathology which can have an echo on the rachis such as a length disparity or a flexum
  • Subject with spine and pelvis surgery antecedents.
  • Person placed under protection of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Unit 2, University Hospital

Bordeaux, 33076, France

Location

Related Publications (17)

  • Borenstein D. Low back pain: epidemiology, etiology, diagnostic evaluation, and therapy. Curr Opin Rheumatol. 1991 Apr;3(2):207-17.

    PMID: 1829622BACKGROUND

  • Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

    PMID: 18046031BACKGROUND

  • Cats-Baril WL, Frymoyer JW. Identifying patients at risk of becoming disabled because of low-back pain. The Vermont Rehabilitation Engineering Center predictive model. Spine (Phila Pa 1976). 1991 Jun;16(6):605-7. doi: 10.1097/00007632-199106000-00001.

    PMID: 1830688BACKGROUND

  • Dubousset J, Charpak G, Dorion I, Skalli W, Lavaste F, Deguise J, Kalifa G, Ferey S. [A new 2D and 3D imaging approach to musculoskeletal physiology and pathology with low-dose radiation and the standing position: the EOS system]. Bull Acad Natl Med. 2005 Feb;189(2):287-97; discussion 297-300. French.

    PMID: 16114859BACKGROUND

  • Kalifa G, Charpak Y, Maccia C, Fery-Lemonnier E, Bloch J, Boussard JM, Attal M, Dubousset J, Adamsbaum C. Evaluation of a new low-dose digital x-ray device: first dosimetric and clinical results in children. Pediatr Radiol. 1998 Jul;28(7):557-61. doi: 10.1007/s002470050413.

    PMID: 9662585BACKGROUND

  • Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.

    PMID: 11725230BACKGROUND

  • Geijer H, Verdonck B, Beckman KW, Andersson T, Persliden J. Digital radiography of scoliosis with a scanning method: radiation dose optimization. Eur Radiol. 2003 Mar;13(3):543-51. doi: 10.1007/s00330-002-1476-1. Epub 2002 Jun 14.

    PMID: 12594558BACKGROUND

  • Glassman S, Gornet MF, Branch C, Polly D Jr, Peloza J, Schwender JD, Carreon L. MOS short form 36 and Oswestry Disability Index outcomes in lumbar fusion: a multicenter experience. Spine J. 2006 Jan-Feb;6(1):21-6. doi: 10.1016/j.spinee.2005.09.004.

    PMID: 16413443BACKGROUND

  • Hansen J, Jurik AG, Fiirgaard B, Egund N. Optimisation of scoliosis examinations in children. Pediatr Radiol. 2003 Nov;33(11):752-65. doi: 10.1007/s00247-003-1015-5. Epub 2003 Sep 5.

    PMID: 12961040BACKGROUND

  • Legaye J, Duval-Beaupere G, Hecquet J, Marty C. Pelvic incidence: a fundamental pelvic parameter for three-dimensional regulation of spinal sagittal curves. Eur Spine J. 1998;7(2):99-103. doi: 10.1007/s005860050038.

    PMID: 9629932BACKGROUND

  • Pellise F, Hernandez A, Vidal X, Minguell J, Martinez C, Villanueva C. Radiologic assessment of all unfused lumbar segments 7.5 years after instrumented posterior spinal fusion. Spine (Phila Pa 1976). 2007 Mar 1;32(5):574-9. doi: 10.1097/01.brs.0000256875.17765.e6.

    PMID: 17334293BACKGROUND

  • Rossignol M, Suissa S, Abenhaim L. Working disability due to occupational back pain: three-year follow-up of 2,300 compensated workers in Quebec. J Occup Med. 1988 Jun;30(6):502-5.

    PMID: 2969044BACKGROUND

  • Roussouly P, Berthonnaud E, Dimnet J. [Geometrical and mechanical analysis of lumbar lordosis in an asymptomatic population: proposed classification]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):632-9. French.

    PMID: 14699309BACKGROUND

  • Spengler DM, Bigos SJ, Martin NA, Zeh J, Fisher L, Nachemson A. Back injuries in industry: a retrospective study. I. Overview and cost analysis. Spine (Phila Pa 1976). 1986 Apr;11(3):241-5. doi: 10.1097/00007632-198604000-00010.

    PMID: 2940707BACKGROUND

  • Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine (Phila Pa 1976). 1987 Sep;12(7 Suppl):S1-59. No abstract available.

    PMID: 2961086BACKGROUND

  • Tournier C, Aunoble S, Le Huec JC, Lemaire JP, Tropiano P, Lafage V, Skalli W. Total disc arthroplasty: consequences for sagittal balance and lumbar spine movement. Eur Spine J. 2007 Mar;16(3):411-21. doi: 10.1007/s00586-006-0208-7. Epub 2006 Sep 8.

    PMID: 16960704BACKGROUND

  • Le Huec JC, Demezon H, Aunoble S. Sagittal parameters of global cervical balance using EOS imaging: normative values from a prospective cohort of asymptomatic volunteers. Eur Spine J. 2015 Jan;24(1):63-71. doi: 10.1007/s00586-014-3632-0. Epub 2014 Oct 26.

    PMID: 25344642RESULT

Study Officials

  • Jean-Charles LE HUEC, PU-PH

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, MD

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 1, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 10, 2026

Record last verified: 2015-01

Locations

FR(1)