Instability of Lumbar SpineNCT00837538
Screening of Instability of the Spinal Column With Spinal Mouse® and X-ray
An observational study of Instability of Lumbar Spine, run by Jyväskylä Central Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Instability of Lumbar Spine
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: persons of Central finland Health Care District
Who may be able to join
- supposed instability of lumbar spine
Who cannot join
- not willing to participate to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Instability of Lumbar Spine
- Keywords
- Spinal sagittal range of motion, Intersegmental range of motion, Spinal Mouse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Back pain | Persons with back pain and supposed instability of lumbar spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal spinal range of motion
Measured: One measurement before or after x-ray film
Secondary outcomes (3)
Pain; pain drawing, VAS
Measured: Once in the same day with range of motion measurements
Oswestry Disability Questionnaire
Measured: Once in the same day with range of motion measurements
Questionnaire; socio-demographic variables, back/leg trouble history
Measured: Once in the same day with range of motion measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instability of Lumbar SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jyväskylä Central Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jari Ylinen, MD, Phd, Study director, Central Finland Health Care DistrictMirja Vuorenmaa, M.Sc., Principal investigator, Central Finland Heallth Care DistrictKirsi Piitulainen, M. Sc., Principal investigator, Central Finland Care DistrictArja Häkkinen, Study chair, Central Finland Heallth Care District, University of Jyväskylä
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837538
- Sponsor's protocol ID
- KSSHP 63/2007
- Other IDs
- KSSHP 63/2007
- Status last verified
- Mar 2011
- First submitted
- 4 Feb 2009
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Spinal Mouse® and X-ray Film to Measure a Instability of Lumbar Spine
- ClinicalTrials.gov ID
- NCT00837538
- Acronym / sponsor ID
- KSSHP 63/2007
- Conditions
- Instability of Lumbar Spine
- Keywords
- Spinal sagittal range of motion, Intersegmental range of motion, Spinal Mouse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jyväskylä Central HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Back pain | – | –Persons with back pain and supposed instability of lumbar spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- persons of Central finland Health Care District
Key inclusion criteria (1 listed)
- supposed instability of lumbar spine
Key exclusion criteria (1 listed)
- not willing to participate to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sagittal spinal range of motion
Time frame: One measurement before or after x-ray film
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Ylinen, MD, Phd study director
Central Finland Health Care District
Mirja Vuorenmaa, M.Sc. principal investigator
Central Finland Heallth Care District
Kirsi Piitulainen, M. Sc. principal investigator
Central Finland Care District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Instability of Lumbar Spine, run by Jyväskylä Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sagittal spinal range of motion (time frame: One measurement before or after x-ray film). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2011.