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TerminatedNCT01600417Updated Nov 22, 2016

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

An observational study in Low Back Pain, sponsored by Swiss Paraplegic Research, Nottwil. Terminated at 1 site in Switzerland. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Swiss Paraplegic Research, Nottwil · Observational

Why this study was terminated
principal investigator has left the institution
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
4
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Low Back Pain

Keywords

  • low back pain
  • spine
  • lumbar spine
  • lumbar instability
  • radiology
  • functional radiology
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 4 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Swiss Paraplegic Research, Nottwil is the lead sponsor of 69 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suffering from chronic low back pain and clinical suspicion of lumbar instability.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
4 participants (actual)

Groups and cohorts

  • clinical suspicion of lumbar instability
06

What researchers measure

Primary outcomes

  1. sagittal translation

    sagittal translation of L1-L5 on conventional radiographs

    Time frame: baseline

Secondary outcomes

  1. patient characteristics

    age

    Time frame: baseline

  2. SF-36 questionnaire

    Time frame: baseline

  3. visual analogue scale of low back pain

    Time frame: baseline

  4. Short Form McGill questionnaire

    Time frame: baseline

  5. sagittal rotation

    sagittal rotation of L1-L5 on conventional radiographs

    Time frame: baseline

  6. Oswestry questionnaire

    Time frame: baseline

  7. patient characteristics

    weight

    Time frame: baseline

  8. patient characteristics

    height

    Time frame: baseline

07

Study locations

1 site
  • Swiss Paraplegic Centre
    Nottwil, LU 6207, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01600417
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
May 17, 2012
Start date
May 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Nov 22, 2016

Study contacts

Niklaus Aebli, Prof
principal investigator · Swiss Paraplegic Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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