Clinical trial NCT01600417: Investigation of Lumbo-sacral Instability Using Custom Made Table - a Pilot Study
Official title: Radiologic Presentation of Lumbo-sacral Instability Using a Custom Made Table - a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain
Keywords: low back pain
spine
lumbar spine
lumbar instability
radiology
functional radiology
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2012-05-17
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from chronic low back pain and clinical suspicion of lumbar instability.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* radicular pain
* pain at more than two locations
* lumbar spine surgery
* scoliosis
* lumbar spondylolysis
* lumbar spondylodiscitis
* 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

Primary outcomes:
measure: sagittal translation
timeFrame: baseline
Secondary outcomes:
measure: patient characteristics
timeFrame: baseline
measure: SF-36 questionnaire
timeFrame: baseline
measure: visual analogue scale of low back pain
timeFrame: baseline
measure: Short Form McGill questionnaire
timeFrame: baseline
measure: sagittal rotation
timeFrame: baseline
measure: Oswestry questionnaire
timeFrame: baseline
measure: patient characteristics
timeFrame: baseline
measure: patient characteristics
timeFrame: baseline
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Swiss Paraplegic Centre
name: Niklaus Aebli, Prof
role: PRINCIPAL_INVESTIGATOR
References: