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

NCT01600417 | Terminated

• 1 other identifier: 2011-11
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• sagittal translation

  sagittal translation of L1-L5 on conventional radiographs

  baseline

Secondary Outcomes (8)

• patient characteristics

  baseline

• SF-36 questionnaire

  baseline

• visual analogue scale of low back pain

  baseline

• Short Form McGill questionnaire

  baseline

• sagittal rotation

  baseline

Study Arms (1)

clinical suspicion of lumbar instability

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Niklaus Aebli, Prof

  Swiss Paraplegic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 17, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

CH (1)