Discal SciaticaPhase 3EPI-AMELIENCT02151045
Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica
A Phase 3 study testing Non target epidural infiltration done at L3-L4 stage and Epidural infiltration on contact of disco radicular conflict in people with Discal Sciatica, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Discal Sciatica
- What is being tested?
- Non target epidural infiltration done at L3-L4 stage and Epidural infiltration on contact of disco radicular conflict
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2012to Mar 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Aged from 18 to 65 years
- Affiliated or benefit from an insurance regimen
- Patient with a sciatic answering to the definition
- Discal sciatica more than 15 days and less than 6 months
- Discal hernia (scan or RMI)
- Negative BHCG and normal coagulation parameters
Who cannot join
- History of lumbar surgery
- Spinal infiltration of corticoids in 30 days before inclusion
- Iode allergy
- Anticoagulation therapy, unbalanced type 2 diabetes, instable HTA
- Motor loss < 4 (muscular testing)
- Sphincter disorder (cauda equida syndrome)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
Eric ET THOMAS, MD, +33 4 67 33 86 40, e-thomas@chu-montpellier.fr
Eric ET THOMAS, MD
- Recruiting
CHU Carémeau
Nîmes, 30000
Cécile CG GAUJOUX-VIALA, MD, +33 4 66 68 31 20, cecilegaujouxviala@yahoo.fr
Cécile CG GAUJOUX-VIALA, MD
About this study
Official title: Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica - Controlled Randomized Trial With Double Blind Evaluation
In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.
- Conditions
- Discal Sciatica
- Being tested
- Non target epidural infiltration done at L3-L4 stage, Epidural infiltration on contact of disco radicular conflict
- Keywords
- Epidural infiltration of Corticoids, L3-L4 stage, On contact of disco radicular conflict, Scan control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non target epidural infiltration done at L3-L4 stageProcedure or surgery
For patients included in control arm, a non target posterior epidural space infiltration of corticoids will be done at L3-L4 stage on scan control
Epidural infiltration on contact of disco radicular conflictProcedure or surgery
For patients included in experimental arm, an epidural infiltration of corticoids will be done in lateral on contact of disco radicular conflict on scan control.
| Study group | Role | What they receive |
|---|---|---|
| Non target epidural infiltration at L3-L4 stage | Active comparator | In this control arm, there are patients with a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control.
These patients must have a discal hernia confirmed by scanner or RMI Receives: Procedure: Non target epidural infiltration done at L3-L4 stage |
| Epidural infiltration on contact of disco radicular conflict | Experimental | In this experimental arm, there are patients with an epidural infiltration of corticoids done in lateral on contact of disco radicular conflict on scan control.
These patients must have a discal hernia confirmed by scanner or RMI Receives: Procedure: Epidural infiltration on contact of disco radicular conflict |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evolution on analogic visual scale (EVA) ay Day 30
Measured: at Day 30 after infiltration
Secondary outcomes (20)
Pain evolution on analogic visual scal (EVA) at Day 7
Measured: at day 7 after infiltration
Pain evolution on analogic visual scal (EVA) at month 3
Measured: at month 3 after infiltration
Pain evolution on analogic visual scal (EVA) at month 6
Measured: at month 6 after infiltration
Pain evolution on analogic visual scal (EVA) at month 12
Measured: at month 12 after infiltration
drug consumption at day 7
Measured: at day 7 after infiltration
drug consumption at month 3
Measured: at month 3 after infiltration
drug consumption at month 6
Measured: at month 6 after infiltration
drug consumption at month 12
Measured: at month 12 after infiltration
functional handicap at Day 7
functional handicap is assessed by auto-questionnary
Measured: at day 7 after infiltration
functional handicap at month 3
functional handicap is assessed by auto-questionnary
Measured: at month 3 after infiltration
functional handicap at month 6
functional handicap is assessed by auto-questionnary
Measured: at month 6 after infiltration
functional handicap at month 12
functional handicap is assessed by auto-questionnary
Measured: at month 12 after infiltration
professional activity recovery at Day 7
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Measured: at day 7 after infiltration
professional activity recovery at month 3
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Measured: at month 3 after infiltration
professional activity recovery at month 6
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Measured: at month 6 after infiltration
professional activity recovery at month 12
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Measured: at month 12 after infiltration
new epidural infiltration or surgery of discal hernia at Day 7
Measured: at day 7 after infiltration
new epidural infiltration or surgery of discal hernia at month 3
Measured: at month 3 after infiltration
new epidural infiltration or surgery of discal hernia at month 6
Measured: at month 6 after infiltration
new epidural infiltration or surgery of discal hernia at month 12
Measured: at month 12 after infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discal SciaticaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric ET THOMAS, MD, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151045
- Sponsor's protocol ID
- 8708
- Acronym
- EPI-AMELIE
- Status last verified
- Aug 2015
- First submitted
- 28 May 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica - Controlled Randomized Trial With Double Blind Evaluation
- ClinicalTrials.gov ID
- NCT02151045
- Acronym / sponsor ID
- EPI-AMELIE / 8708
- Conditions
- Discal Sciatica
- Keywords
- Epidural infiltration of Corticoids, L3-L4 stage, On contact of disco radicular conflict, Scan control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 30 May 2014 (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.
In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non target epidural infiltration at L3-L4 stage | Active comparator | Procedure: Non target epidural infiltration done at L3-L4 stageIn this control arm, there are patients with a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control. These patients must have a discal hernia confirmed by scanner or RMI |
| Epidural infiltration on contact of disco radicular conflict | Experimental | Procedure: Epidural infiltration on contact of disco radicular conflictIn this experimental arm, there are patients with an epidural infiltration of corticoids done in lateral on contact of disco radicular conflict on scan control. These patients must have a discal hernia confirmed by scanner or RMI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent
- Aged from 18 to 65 years
- Affiliated or benefit from an insurance regimen
- Patient with a sciatic answering to the definition
- Discal sciatica more than 15 days and less than 6 months
Key exclusion criteria (6 listed)
- History of lumbar surgery
- Spinal infiltration of corticoids in 30 days before inclusion
- Iode allergy
- Anticoagulation therapy, unbalanced type 2 diabetes, instable HTA
- Motor loss < 4 (muscular testing)
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 |
|---|---|---|
| Non target epidural infiltration done at L3-L4 stageFor patients included in control arm, a non target posterior epidural space infiltration of corticoids will be done at L3-L4 stage on scan control | Procedure or surgery | Non target epidural infiltration at L3-L4 stage |
| Epidural infiltration on contact of disco radicular conflictFor patients included in experimental arm, an epidural infiltration of corticoids will be done in lateral on contact of disco radicular conflict on scan control. | Procedure or surgery | Epidural infiltration on contact of disco radicular conflict |
Primary outcome
Pain evolution on analogic visual scale (EVA) ay Day 30
Time frame: at Day 30 after infiltration
20 secondary outcomes
Pain evolution on analogic visual scal (EVA) at Day 7
Time frame: at day 7 after infiltration
Pain evolution on analogic visual scal (EVA) at month 3
Time frame: at month 3 after infiltration
Pain evolution on analogic visual scal (EVA) at month 6
Time frame: at month 6 after infiltration
Pain evolution on analogic visual scal (EVA) at month 12
Time frame: at month 12 after infiltration
drug consumption at day 7
Time frame: at day 7 after infiltration
drug consumption at month 3
Time frame: at month 3 after infiltration
drug consumption at month 6
Time frame: at month 6 after infiltration
drug consumption at month 12
Time frame: at month 12 after infiltration
functional handicap at Day 7
Time frame: at day 7 after infiltration
functional handicap at month 3
Time frame: at month 3 after infiltration
functional handicap at month 6
Time frame: at month 6 after infiltration
functional handicap at month 12
Time frame: at month 12 after infiltration
professional activity recovery at Day 7
Time frame: at day 7 after infiltration
professional activity recovery at month 3
Time frame: at month 3 after infiltration
professional activity recovery at month 6
Time frame: at month 6 after infiltration
professional activity recovery at month 12
Time frame: at month 12 after infiltration
new epidural infiltration or surgery of discal hernia at Day 7
Time frame: at day 7 after infiltration
new epidural infiltration or surgery of discal hernia at month 3
Time frame: at month 3 after infiltration
new epidural infiltration or surgery of discal hernia at month 6
Time frame: at month 6 after infiltration
new epidural infiltration or surgery of discal hernia at month 12
Time frame: at month 12 after infiltration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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.
Eric ET THOMAS, MD principal investigator
CHU de Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Non target epidural infiltration done at L3-L4 stage and Epidural infiltration on contact of disco radicular conflict in people with Discal Sciatica, run by University Hospital, Montpellier at 2 sites 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 7 inclusion and 6 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 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Contact Eric ET THOMAS, MD (+33 4 67 33 86 40, e-thomas@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evolution on analogic visual scale (EVA) ay Day 30 (time frame: at Day 30 after 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 1 Sep 2015.