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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ylinen Jari, MD, PhD, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier: NCT00837538     History of Changes
Other Study ID Numbers: KSSHP 63/2007, KSSHP 63/2007
Study First Received: February 4, 2009
Last Updated: March 18, 2011
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on October 29, 2014