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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837538
First Posted: February 5, 2009
Last Update Posted: March 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Jyväskylä Central Hospital
  Purpose
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.

Condition
Instability of Lumbar Spine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Comparison of Spinal Mouse® and X-ray Film to Measure a Instability of Lumbar Spine

Resource links provided by NLM:


Further study details as provided by Jyväskylä Central Hospital:

Primary Outcome Measures:
  • Sagittal spinal range of motion [ Time Frame: One measurement before or after x-ray film ]

Secondary Outcome Measures:
  • Pain; pain drawing, VAS [ Time Frame: Once in the same day with range of motion measurements ]
  • Oswestry Disability Questionnaire [ Time Frame: Once in the same day with range of motion measurements ]
  • Questionnaire; socio-demographic variables, back/leg trouble history [ Time Frame: Once in the same day with range of motion measurements ]

Enrollment: 100
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Back pain
Persons with back pain and supposed instability of lumbar spine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
persons of Central finland Health Care District
Criteria

Inclusion Criteria:

  • supposed instability of lumbar spine

Exclusion Criteria:

  • not willing to participate to study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837538


Locations
Finland
Central Finland Health Care District
Jyväskylä, Finland
Sponsors and Collaborators
Jyväskylä Central Hospital
Investigators
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
  More Information

Responsible Party: Ylinen Jari, MD, PhD, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier: NCT00837538     History of Changes
Other Study ID Numbers: KSSHP 63/2007
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: March 21, 2011
Last Verified: March 2011

Keywords provided by Jyväskylä Central Hospital:
Spinal sagittal range of motion
Intersegmental range of motion
Spinal Mouse