NCT00761111

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

11 months

First QC Date

August 22, 2007

Last Update Submit

October 7, 2008

Conditions

Keywords

information bookletlow back beliefseducationdisc herniadiscectomyA common monoradicular sciaticaon a slipped discwith a clinical radioagreement requiring a surgical treatmentcarried outone durationof evolution higherthan four weeksat naive subjectsof any rachidian interventional treatmentafter failure of an good ambulatory

Outcome Measures

Primary Outcomes (1)

  • Quebec Questionnaire

    after lumbar discectomy

Secondary Outcomes (2)

  • FABQ Questionnaire

    after lumbar discectomy

  • Rachidian and radicular painful intensity

    after lumbar discectomy

Interventions

to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Givron Pascale, Dr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

September 29, 2008

Study Start

June 1, 2007

Primary Completion

May 1, 2008

Last Updated

October 8, 2008

Record last verified: 2008-10