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

November 21, 2016 updated by: Swiss Paraplegic Centre Nottwil

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • LU
      • Nottwil, LU, Switzerland, 6207
        • Swiss Paraplegic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
clinical suspicion of lumbar instability

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Centre Nottwil

Investigators

  • Principal Investigator: Niklaus Aebli, Prof, Swiss Paraplegic Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-11 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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