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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University Hospital, Clermont-Ferrand.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00761111
First received: August 22, 2007
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Back Pain
Behavioral: Assessment of the Your Back Operation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Quebec Questionnaire [ Time Frame: after lumbar discectomy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • FABQ Questionnaire [ Time Frame: after lumbar discectomy ] [ Designated as safety issue: Yes ]
  • Rachidian and radicular painful intensity [ Time Frame: after lumbar discectomy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: June 2007
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00761111

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Givron Pascale, Dr
  More Information

No publications provided

Responsible Party: Pascale GIVRON, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00761111     History of Changes
Other Study ID Numbers: CHU63-0023
Study First Received: August 22, 2007
Last Updated: October 7, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014