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

March 18, 2011 updated by: Jyväskylä Central Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland
        • Central Finland Health Care District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

persons of Central finland Health Care District

Description

Inclusion Criteria:

  • supposed instability of lumbar spine

Exclusion Criteria:

  • not willing to participate to study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Back pain
Persons with back pain and supposed instability of lumbar spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sagittal spinal range of motion
Time Frame: One measurement before or after x-ray film
One measurement before or after x-ray film

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain; pain drawing, VAS
Time Frame: Once in the same day with range of motion measurements
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
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
Once in the same day with range of motion measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 4, 2009

First Submitted That Met QC Criteria

February 4, 2009

First Posted (Estimate)

February 5, 2009

Study Record Updates

Last Update Posted (Estimate)

March 21, 2011

Last Update Submitted That Met QC Criteria

March 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSSHP 63/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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