Low Back PainNCT01600417
Investigation of Lumbo-sacral Instability Using Custom Made Table - a Pilot Study
An observational study of Low Back Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate the feasibility and validity of conventional radiographs of the lumbo-sacral spine when the patient is lying on a special table which facilitates maximal lumbo-sacral flexion. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients suffering from chronic low back pain and clinical suspicion of lumbar instability.
Who may be able to join
- chronic low back pain (≥ 3 months)
- clinical suspicion of lumbo-sacral instability
- functional conventional radiographs of lumbar spine
- pain intensity > 4 / 10 on visual analogue scale
- age 20-60 years
Who cannot join
- radicular pain
- pain at more than two locations
- lumbar spine surgery
- scoliosis
- lumbar spondylolysis
- lumbar spondylodiscitis
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- anatomic aberrations of lumbar spine
- unconsolidated spine fractures
- neurologic deficits
- spine tumor
- neuromuscular disease
- rheumatic disease
- severe osteoporosis
- radiotherapy within the last 5 years
- pregnancy
- insufficient German language skills
- no informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Radiologic Presentation of Lumbo-sacral Instability Using a Custom Made Table - a Pilot Study
The aim of the study is to evaluate the feasibility and validity of conventional radiographs of the lumbo-sacral spine when the patient is lying on a special table which facilitates maximal lumbo-sacral flexion. The results gained from the radiographs with the patient on the table will be compared with those gained from standard flexion-extension radiographs of the lumbo-sacral spine.
Read the detailed description
After enrollment in the study patients will complete a set of questionnaire concerning degree, extent and quality of their low back problem. Afterwards a lateral conventional radiograph of the lumbar spine with the patient on a custom made positioning table will be taken. The table facilitates optimal flexion of the lumbar spine. Afterwards sagittal translation and rotation are measured on the flexion-extension radiographs and the radiograph taken on the custom made table. Differences between the measurements will be determined.
- Conditions
- Low Back Pain
- Keywords
- low back pain, spine, lumbar spine, lumbar instability, radiology, functional radiology
- Medical subject headings
- Low Back Pain
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 |
|---|---|---|
| clinical suspicion of lumbar instability | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
sagittal translation
sagittal translation of L1-L5 on conventional radiographs
Measured: baseline
Secondary outcomes (8)
patient characteristics
age
Measured: baseline
SF-36 questionnaire
Measured: baseline
visual analogue scale of low back pain
Measured: baseline
Short Form McGill questionnaire
Measured: baseline
sagittal rotation
sagittal rotation of L1-L5 on conventional radiographs
Measured: baseline
Oswestry questionnaire
Measured: baseline
patient characteristics
weight
Measured: baseline
patient characteristics
height
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: principal investigator has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Niklaus Aebli, Prof, Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600417
- Sponsor's protocol ID
- 2011-11
- Status last verified
- Nov 2016
- First submitted
- 8 May 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiologic Presentation of Lumbo-sacral Instability Using a Custom Made Table - a Pilot Study
- ClinicalTrials.gov ID
- NCT01600417
- Acronym / sponsor ID
- 2011-11
- Conditions
- Low Back Pain
- Keywords
- low back pain, spine, lumbar spine, lumbar instability, radiology, functional radiology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: principal investigator has left the institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 May 2012 (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 aim of the study is to evaluate the feasibility and validity of conventional radiographs of the lumbo-sacral spine when the patient is lying on a special table which facilitates maximal lumbo-sacral flexion. The results gained from the radiographs with the patient on the table will be compared with those gained from standard flexion-extension radiographs of the lumbo-sacral spine.
Detailed description
After enrollment in the study patients will complete a set of questionnaire concerning degree, extent and quality of their low back problem. Afterwards a lateral conventional radiograph of the lumbar spine with the patient on a custom made positioning table will be taken. The table facilitates optimal flexion of the lumbar spine. Afterwards sagittal translation and rotation are measured on the flexion-extension radiographs and the radiograph taken on the custom made table. Differences between the measurements will be determined.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinical suspicion of lumbar instability | – | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients suffering from chronic low back pain and clinical suspicion of lumbar instability.
Key inclusion criteria (5 listed)
- chronic low back pain (≥ 3 months)
- clinical suspicion of lumbo-sacral instability
- functional conventional radiographs of lumbar spine
- pain intensity > 4 / 10 on visual analogue scale
- age 20-60 years
Key exclusion criteria (17 listed)
- radicular pain
- pain at more than two locations
- lumbar spine surgery
- scoliosis
- lumbar spondylolysis
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 translation
Time frame: baseline
sagittal translation of L1-L5 on conventional radiographs
8 secondary outcomes
patient characteristics
Time frame: baseline
SF-36 questionnaire
Time frame: baseline
visual analogue scale of low back pain
Time frame: baseline
Short Form McGill questionnaire
Time frame: baseline
sagittal rotation
Time frame: baseline
Oswestry questionnaire
Time frame: baseline
patient characteristics
Time frame: baseline
patient characteristics
Time frame: baseline
Results and safety
The study was stopped early (reason given: principal investigator has left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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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.
Niklaus Aebli, Prof principal investigator
Swiss Paraplegic Centre
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 Low Back Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 22 Nov 2016. 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 Switzerland. 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 was stopped early (reason given: principal investigator has left the institution). Results are not available in the source record.
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 translation (time frame: baseline). 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 22 Nov 2016.