Back PainPhase 3NCT00761111
Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?
A Phase 3 study testing Assessment of the Your Back Operation in people with Back Pain, run by University Hospital, Clermont-Ferrand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Assessment of the Your Back Operation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to May 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
The purpose of this study is to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Assessment of the Your Back Operation
- 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
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the Your Back OperationBehavioural
to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Quebec Questionnaire
Measured: after lumbar discectomy
Secondary outcomes (2)
FABQ Questionnaire
Measured: after lumbar discectomy
Rachidian and radicular painful intensity
Measured: after lumbar discectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Givron Pascale, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761111
- Sponsor's protocol ID
- CHU63-0023
- Status last verified
- Oct 2008
- First submitted
- 22 Aug 2007
- Last updated
- 8 Oct 2008
- Results posted
- No
Publications
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.
PubMed 26776321
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?
- ClinicalTrials.gov ID
- NCT00761111
- Acronym / sponsor ID
- CHU63-0023
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2008 (estimated)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the Your Back Operationto translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy | Behavioural | – |
Primary outcome
Quebec Questionnaire
Time frame: after lumbar discectomy
2 secondary outcomes
FABQ Questionnaire
Time frame: after lumbar discectomy
Rachidian and radicular painful intensity
Time frame: after lumbar discectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
- Derived from this study: PubMed 26776321Claus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Givron Pascale, Dr principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Assessment of the Your Back Operation in people with Back Pain, run by University Hospital, Clermont-Ferrand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quebec Questionnaire (time frame: after lumbar discectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2008.