Clinical trial NCT00761111: Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?
Official title: Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Back Pain
Keywords: information booklet
low back beliefs
education
disc hernia
discectomy
A common monoradicular sciatica
on a slipped disc
with a clinical radio
agreement requiring a surgical treatment
carried out
one duration
of evolution higher
than four weeks
at naive subjects
of any rachidian interventional treatment
after failure of an good ambulatory
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2008-09-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quebec Questionnaire
timeFrame: after lumbar discectomy
Secondary outcomes:
measure: FABQ Questionnaire
timeFrame: after lumbar discectomy
measure: Rachidian and radicular painful intensity
timeFrame: after lumbar discectomy
Other outcomes:
Locations:
Study officials:
name: Givron Pascale, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claus D, Coudeyre E, Chazal J, Irthum B, Mulliez A, Givron P. An evidence-based information booklet helps reduce fear-avoidance beliefs after first-time discectomy for disc prolapse. Ann Phys Rehabil Med. 2017 Apr;60(2):68-73. doi: 10.1016/j.rehab.2015.10.008. Epub 2016 Jan 6.