Reliability, Validity of Measurement to Assess Lumbar Spine MotionNCT03763994
Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients
An observational study of Reliability, Validity of Measurement to Assess Lumbar Spine Motion and Comparison of Healthy Subjects and Low Back Pain Patients, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Main of the study is to assess the reliability of a new objective tool to measure lumbar spine motion. The data will be collected from healthy subjects and subjects with frequent or daily low back pain in the last three months. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Reliability, Validity of Measurement to Assess Lumbar Spine Motion, Comparison of Healthy Subjects and Low Back Pain Patients
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Dec 2013
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Low back pain patients were recruited among in-and outpatients of the Department of Pain Medicine at the Bergmannsheil, Bochum. The subjects of the control groups were recruited by distributing flyers in sport groups and among hospital staff and friends.
Who may be able to join
- older than 18 years, informed consent, sufficient German skills <30 days low back pain in the last 90 days (control group) >31days of low back pain in the last 90 days (low back pain group)
Who cannot join
- neurological disorder (including multiple sclerosis, Stroke, Parkinson´s disease), Current pain >= 4 (NSR)/intake of analgesic in the last 24h/ previous low back surgery (control group), inability to perform choreography (LBP group)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Berufsgenossenschaftliches Universitätklinikum Bergmannsheil
Bochum, Northrine-Westfalia, 44789
About this study
Main of the study is to assess the reliability of a new objective tool to measure lumbar spine motion. The data will be collected from healthy subjects and subjects with frequent or daily low back pain in the last three months. In addition we compare the results of the motion measurements with disability and pain questionnaires such as the Roland Morris, Oswestry Disability Index and the Brief Pain Inventory.
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 |
|---|---|---|
| Control group 1 | Never low back pain in the last 3 months | |
| Control group 2 | occasionally (1-30days) low back pain in the last 3 months | |
| Low back pain group 3 | frequently (31-60days) low back pain in the last 3 months | |
| Low back pain group 4 | daily (61-90days) low back pain in the last 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability of measurement tool
reliability of measurement tool
Measured: February 2012-February 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study startMar 2012
- Primary completionNov 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reliability, Validity of Measurement to Assess Lumbar Spine MotionStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763994
- Sponsor's protocol ID
- 4385-12
- Status last verified
- Dec 2018
- First submitted
- 20 Dec 2012
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03763994
- Acronym / sponsor ID
- 4385-12
- Conditions
- Reliability, Validity of Measurement to Assess Lumbar Spine Motion, Comparison of Healthy Subjects and Low Back Pain Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Dec 2018 (actual)
- 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.
Main of the study is to assess the reliability of a new objective tool to measure lumbar spine motion. The data will be collected from healthy subjects and subjects with frequent or daily low back pain in the last three months. In addition we compare the results of the motion measurements with disability and pain questionnaires such as the Roland Morris, Oswestry Disability Index and the Brief Pain Inventory.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group 1 | – | –Never low back pain in the last 3 months |
| Control group 2 | – | –occasionally (1-30days) low back pain in the last 3 months |
| Low back pain group 3 | – | –frequently (31-60days) low back pain in the last 3 months |
| Low back pain group 4 | – | –daily (61-90days) low back pain in the last 3 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Low back pain patients were recruited among in-and outpatients of the Department of Pain Medicine at the Bergmannsheil, Bochum. The subjects of the control groups were recruited by distributing flyers in sport groups and among hospital staff and friends.
Key inclusion criteria (1 listed)
- older than 18 years, informed consent, sufficient German skills <30 days low back pain in the last 90 days (control group) >31days of low back pain in the last 90 days (low back pain group)
Key exclusion criteria (1 listed)
- neurological disorder (including multiple sclerosis, Stroke, Parkinson´s disease), Current pain >= 4 (NSR)/intake of analgesic in the last 24h/ previous low back surgery (control group), inability to perform choreography (LBP group)
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
reliability of measurement tool
Time frame: February 2012-February 2013
reliability of measurement tool
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 4 Dec 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Reliability, Validity of Measurement to Assess Lumbar Spine Motion and Comparison of Healthy Subjects and Low Back Pain Patients, run by Ruhr University of Bochum at 1 site in Germany.
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 4 Dec 2018. 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 Germany. 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?
reliability of measurement tool (time frame: February 2012-February 2013). 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 4 Dec 2018.