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Screening of Instability of the Spinal Column With Spinal Mouse® and X-ray

This study has been completed.
Sponsor:
Information provided by:
Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:
NCT00837538
First received: February 4, 2009
Last updated: March 18, 2011
Last verified: March 2011
History of Changes

February 4, 2009
March 18, 2011
February 2009
March 2011   (final data collection date for primary outcome measure)
Sagittal spinal range of motion [ Time Frame: One measurement before or after x-ray film ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837538 on ClinicalTrials.gov Archive Site
  • Pain; pain drawing, VAS [ Time Frame: Once in the same day with range of motion measurements ] [ Designated as safety issue: No ]
  • Oswestry Disability Questionnaire [ Time Frame: Once in the same day with range of motion measurements ] [ Designated as safety issue: No ]
  • Questionnaire; socio-demographic variables, back/leg trouble history [ Time Frame: Once in the same day with range of motion measurements ] [ Designated as safety issue: No ]
  • Pain; pain drawing, VAS [ Time Frame: Once in the same day with range of motion measurements ] [ Designated as safety issue: No ]
  • Oswestry Disability Questionnaire [ Time Frame: Once in the same day with range of motion measurements ] [ Designated as safety issue: No ]
  • Questionnaire; sosio-demographic variables, back/leg trouble history [ Time Frame: Once in the same day with range of motion measurements ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Screening of Instability of the Spinal Column With Spinal Mouse® and X-ray
A Comparison of Spinal Mouse® and X-ray Film to Measure a Instability of Lumbar Spine

The SpinalMouse is a computer-assisted medical device that measures and graphically reports on posture and range of motion of the axial spine. The data has shown to be highly valid and reproducible while compared to x-ray film. The aim of the study is to evaluate if the Spinal Mouse is a reliable clinical diagnostic device to screen those patients having instability in the lumbar area.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

persons of Central finland Health Care District
Instability of Lumbar Spine
Not Provided
Back pain
Persons with back pain and supposed instability of lumbar spine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • supposed instability of lumbar spine

Exclusion Criteria:

  • not willing to participate to study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00837538
KSSHP 63/2007, KSSHP 63/2007
No
Ylinen Jari, MD, PhD, Jyväskylä Central Hospital
Jyväskylä Central Hospital
Not Provided
Study Director: Jari Ylinen, MD, Phd Central Finland Health Care District
Principal Investigator: Mirja Vuorenmaa, M.Sc. Central Finland Heallth Care District
Principal Investigator: Kirsi Piitulainen, M. Sc. Central Finland Care District
Study Chair: Arja Häkkinen Central Finland Heallth Care District, University of Jyväskylä
Jyväskylä Central Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP