Investigation of Lumbo-sacral Instability Using Custom Made Table - a Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Radiologic Presentation of Lumbo-sacral Instability Using a Custom Made Table - a Pilot Study

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| clinical suspicion of lumbar instability<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sagittal translation | sagittal translation of L1-L5 on conventional radiographs | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient characteristics | age | baseline | 
| SF-36 questionnaire |  | baseline | 
| visual analogue scale of low back pain |  | baseline | 
| Short Form McGill questionnaire |  | baseline | 
| sagittal rotation | sagittal rotation of L1-L5 on conventional radiographs | baseline | 
| Oswestry questionnaire |  | baseline | 
| patient characteristics | weight | baseline | 
| patient characteristics | height | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, spine, lumbar spine, lumbar instability, radiology, functional radiology