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

Terminated

• Conditions: Low Back Pain

• Registration Number: NCT01600417
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sagittal translation	baseline	sagittal translation of L1-L5 on conventional radiographs

Secondary Outcome Measures

Name	Time	Method
patient characteristics	baseline	height
SF-36 questionnaire	baseline
visual analogue scale of low back pain	baseline
Short Form McGill questionnaire	baseline
sagittal rotation	baseline	sagittal rotation of L1-L5 on conventional radiographs
Oswestry questionnaire	baseline

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland