Overview

This trial is active, not recruiting.

Condition back pain
Treatment assessment of the your back operation
Phase phase 3
Sponsor University Hospital, Clermont-Ferrand
Start date June 2007
End date May 2008
Trial size 140 participants
Trial identifier NCT00761111, CHU63-0023

Summary

The purpose of this study is to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)

Primary Outcomes

Measure
Quebec Questionnaire
time frame: after lumbar discectomy

Secondary Outcomes

Measure
FABQ Questionnaire
time frame: after lumbar discectomy
Rachidian and radicular painful intensity
time frame: after lumbar discectomy

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - A common monoradicular sciatica on a slipped disc with a clinical radio agreement requiring a surgical treatment, after failure of an good ambulatory treatment carried out, one duration of evolution higher than four weeks at naive subjects of any rachidian intervention Exclusion Criteria: - People presenting a cruralgia, a secondary sciatica (epiduritis, osseous metastasis...) or without relationship with a slipped disc (spinal stenosis), an lesion biradicular, an horse tail syndrome, an important motor deficit (muscular testing < 3) - Cognitive, auditive, major visual disorders or any subject which does not have a good comprehension of spoken French and/or writing, or having recourse to a third for reading and supplementing a document - Subjects presenting a peripheral neuropathy, a severe and evolved diabetes, a cardiac insufficiency, dialysed subject - People observing a treatment which included psychotropics for more than three months (other that light hypnotic) because of the disturbances of vigilance and memory

Additional Information

Official title Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?
Principal investigator Givron Pascale, Dr
Description A translation / back-translation of the Your back operation was performed and a before / after prospective study was realized. Main outcome assessment was the Quebec Questionnaire. Demographic data, personal medical sciatica pain history, graduation of the whole subject were recorded. Acceptability of the booklet was also measured.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by University Hospital, Clermont-Ferrand.