SciaticaECHORACHISNCT01832844
Effects of Control Scan for Presumed Difficult Epidural Infiltrations (ECHORACHIS)
A study testing Group " with scan prior to infiltration " and Group " without scan " in people with Sciatica, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of this care protocol is to study the effects of scan to help epidural infiltration realization, in presumed difficult patients suffering from sciatica. These scans are already performed in our Rheumatology Department but our objective is to evaluate objectively its contribution for patients and doctors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica
- What is being tested?
- Group " with scan prior to infiltration " and Group " without scan "
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jan 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients hospitalized in Rheumatology Department for performing their first epidural infiltration when sciatica is resistant to medical treatment.
- Inclusion of patients older than 60 years and / or BMI superior to 30 and / or scoliosis
Who cannot join
- Refusal to participate
- History of spinal surgery
- Anticoagulant or antiplatelet
- History of spinal malformations type spina bifida
- pregnancy
- Age<18
Show all 9Show fewer
- Patients under guardianship
- Patients participating to another clinical trial (except non interventional trials)
- Patients unable to achieve the protocol, in the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial
The aim of this care protocol is to study the effects of scan to help epidural infiltration realization, in presumed difficult patients suffering from sciatica.
These scans are already performed in our Rheumatology Department but our objective is to evaluate objectively its contribution for patients and doctors.
Read more
Epidural infiltration in young patients, with an easy anatomical identification, causes generally no technical difficulties, therefore this protocol will only include patients presumed to have a difficult infiltration, that means those aged more than 60, and/or with BMI > 30 and/or suffering from scoliosis.
This study concerns patients who are hospitalized in Rheumatology Department (Hospital of Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.
Patient will be randomized at Day 0, before infiltration. This latter will be performed in accordance to current practice.
Tolerance data (pain and satisfaction) will be collected just after the infiltration and eventual complications will be reported within 48 hours after infiltration.
Following treatment of lombosciatic will be realized through hospitalization, as usual.
Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the musculoskeletal clinical exam and it has already changed our rheumatology practices. The investigators hope at the end of this study, that results would confirm that scan can be a help in practice to perform epidural infiltrations.
- Conditions
- Sciatica
- Being tested
- Group " with scan prior to infiltration ", Group " without scan "
- Keywords
- Scan control, Epidural infiltration, visual analogue scale (VAS)
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group " with scan prior to infiltration "Procedure or surgery
Scan will be conducted by the operator performing the gesture. He will examine the lumbar spine from L3 to S1, in longitudinal and cross sections and determine the best surgical approach. This will be defined by the largest interspinous space or better visibility of the epidural space. The depth of the epidural space will be noted. The selected stage will be marked with a skin pen to facilitate its location thereafter
Group " without scan "Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group " with scan prior to infiltration " | Active comparator | Not described Receives: Procedure: Group " with scan prior to infiltration " |
| Group " without scan " | Placebo comparator | Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions Receives: Procedure: Group " without scan " |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale measuring the pain during infiltration
To evaluate if scan prior to epidural infiltration could improve its tolerance
Measured: 10min after the infiltration
Secondary outcomes (10)
Infiltration evaluation: procedure time between skin passage and release of the needle
Measured: 10min after the infiltration
Infiltration evaluation: attempts number before correct positioning of needle
Measured: 10min after the infiltration
Infiltration evaluation: number of puncture sites
Measured: 10min after the infiltration
Infiltration evaluation: number of failures
Measured: 10min after the infiltration
Infiltration tolerance : VAS for pain (graduating from 0 to 10)
Measured: 48 hours
Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
Measured: 48 hours
Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
Measured: 10min after the infiltration
Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1
Measured: 10min after the infiltration
Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "
Measured: 10min after the infiltration
Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "
Measured: 10min after the infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit LE GOFF, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832844
- Sponsor's protocol ID
- RC13_0096
- Acronym
- ECHORACHIS
- Status last verified
- Mar 2014
- First submitted
- 4 Apr 2013
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial
- ClinicalTrials.gov ID
- NCT01832844
- Acronym / sponsor ID
- ECHORACHIS / RC13_0096
- Conditions
- Sciatica
- Keywords
- Scan control, Epidural infiltration, visual analogue scale (VAS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Apr 2013 (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 aim of this care protocol is to study the effects of scan to help epidural infiltration realization, in presumed difficult patients suffering from sciatica.
These scans are already performed in our Rheumatology Department but our objective is to evaluate objectively its contribution for patients and doctors.
Epidural infiltration in young patients, with an easy anatomical identification, causes generally no technical difficulties, therefore this protocol will only include patients presumed to have a difficult infiltration, that means those aged more than 60, and/or with BMI > 30 and/or suffering from scoliosis.
This study concerns patients who are hospitalized in Rheumatology Department (Hospital of Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.
Patient will be randomized at Day 0, before infiltration. This latter will be performed in accordance to current practice.
Tolerance data (pain and satisfaction) will be collected just after the infiltration and eventual complications will be reported within 48 hours after infiltration.
Following treatment of lombosciatic will be realized through hospitalization, as usual.
Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the musculoskeletal clinical exam and it has already changed our rheumatology practices. The investigators hope at the end of this study, that results would confirm that scan can be a help in practice to perform epidural infiltrations.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group " with scan prior to infiltration " | Active comparator | Procedure: Group " with scan prior to infiltration " |
| Group " without scan " | Placebo comparator | Procedure: Group " without scan "Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major patients hospitalized in Rheumatology Department for performing their first epidural infiltration when sciatica is resistant to medical treatment.
- Inclusion of patients older than 60 years and / or BMI superior to 30 and / or scoliosis
Key exclusion criteria (9 listed)
- Refusal to participate
- History of spinal surgery
- Anticoagulant or antiplatelet
- History of spinal malformations type spina bifida
- pregnancy
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 |
|---|---|---|
| Group " with scan prior to infiltration "Scan will be conducted by the operator performing the gesture. He will examine the lumbar spine from L3 to S1, in longitudinal and cross sections and determine the best surgical approach. This will be defined by the largest interspinous space or better visibility of the epidural space. The depth of the epidural space will be noted. The selected stage will be marked with a skin pen to facilitate its location thereafter | Procedure or surgery | Group " with scan prior to infiltration " |
| Group " without scan " | Procedure or surgery | Group " without scan " |
Primary outcome
Visual analogue scale measuring the pain during infiltration
Time frame: 10min after the infiltration
To evaluate if scan prior to epidural infiltration could improve its tolerance
10 secondary outcomes
Infiltration evaluation: procedure time between skin passage and release of the needle
Time frame: 10min after the infiltration
Infiltration evaluation: attempts number before correct positioning of needle
Time frame: 10min after the infiltration
Infiltration evaluation: number of puncture sites
Time frame: 10min after the infiltration
Infiltration evaluation: number of failures
Time frame: 10min after the infiltration
Infiltration tolerance : VAS for pain (graduating from 0 to 10)
Time frame: 48 hours
Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
Time frame: 48 hours
Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
Time frame: 10min after the infiltration
Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1
Time frame: 10min after the infiltration
Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "
Time frame: 10min after the infiltration
Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "
Time frame: 10min after the infiltration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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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.
Benoit LE GOFF, Doctor principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group " with scan prior to infiltration " and Group " without scan " in people with Sciatica, run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analogue scale measuring the pain during infiltration (time frame: 10min after the infiltration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2014.