Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?

Back Pain Clinical Trial

Official title:

Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00761111
• Other study ID #: CHU63-0023
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 22, 2007
• Last updated: October 7, 2008
• Start date: June 2007

Study information

• Verified date: October 2008
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Assessment of the Your Back Operation
to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quebec Questionnaire		after lumbar discectomy	Yes
Secondary	FABQ Questionnaire		after lumbar discectomy	Yes
Secondary	Rachidian and radicular painful intensity		after lumbar discectomy	Yes