Screening of Instability of the Spinal Column With Spinal Mouse® and X-ray
This study has been completed.
Sponsor:
Jyväskylä Central Hospital
Information provided by:
Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:
NCT00837538
First received: February 4, 2009
Last updated: March 18, 2011
Last verified: March 2011
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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
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 May 22, 2013