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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01600417
Enrollment
4
Registered
2012-05-17
Start date
2012-05-31
Completion date
2013-12-31
Last updated
2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, spine, lumbar spine, lumbar instability, radiology, functional radiology

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.

Interventions

None listed

Sponsors

Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
sagittal translationbaselinesagittal translation of L1-L5 on conventional radiographs

Secondary

MeasureTime frameDescription
SF-36 questionnairebaseline
visual analogue scale of low back painbaseline
patient characteristicsbaselineage
sagittal rotationbaselinesagittal rotation of L1-L5 on conventional radiographs
Oswestry questionnairebaseline
Short Form McGill questionnairebaseline

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026