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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01600417
• Other study ID #: 2011-11
• Status: Terminated
• Phase: N/A
• First received: May 8, 2012
• Last updated: November 21, 2016
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sagittal translation	sagittal translation of L1-L5 on conventional radiographs	baseline	No
Secondary	patient characteristics	age	baseline	No
Secondary	SF-36 questionnaire		baseline	No
Secondary	visual analogue scale of low back pain		baseline	No
Secondary	Short Form McGill questionnaire		baseline	No
Secondary	sagittal rotation	sagittal rotation of L1-L5 on conventional radiographs	baseline	No
Secondary	Oswestry questionnaire		baseline	No
Secondary	patient characteristics	weight	baseline	No
Secondary	patient characteristics	height	baseline	No