Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)Phase 4NCT01206699
Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago
A Phase 4 study testing corticoid (altim® 1.5 ml) and physiological solution (1.5 ml) in people with Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation), run by Nantes University Hospital at 2 sites in France.
Trial summary
The specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)
- What is being tested?
- corticoid (altim® 1.5 ml) and physiological solution (1.5 ml)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2010to Feb 2015
- Phase
- Phase 4
- 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
- Adult with age equal or above to 18.
- Subject affiliated to French health insurance (Sécurité Sociale)
- Lateralized lumbago on side of the neo-articulation evolving since more than 3 months
- Mechanical pain, lumbar low level or gluteal without sciatic irradiation (pain above the knee)
- Mean pain during the latest 24 hours above 4 on an analogic visual scale (from 0 to 10)- Pain induced by palpation in regards to the neo-articulation
- Pain not relieved by medical treatment with non steroids anti- inflammatory drugs or antalgics
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- No clinical proof for a discal origin : inducing factor, impulsiveness, spinal syndrome, true Lasègue
- transverse-sacral abnormality of IIb, IIIa, IIIc or IV type with neo-articulation lateralized on side of pain
- Informed consent form signed
Who cannot join
- Age below 18
- Clinical arguments in favour of a discal origin
- Pregnant women or women that could become pregnant the day of the infiltration
- Diabetic patient
- Patient unable to understand the protocol
- No autonomy for coming to the hospital (no budget allocated for patient transportation)
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- Hypersensitivity to local anesthetics with "liaison amide"
- Hypersensitivity to one of the components
- Porphyria- Local or generalized infection, suspiscion of infection
- Severe troubles of coagulation, anti-coagulant treatment taken
- Bilateral lumbago with bilateral neo-articulation
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital of La Roche/Yon
La Roche/Yon, 85925
Nantes Hospital
Nantes, 44093
About this study
Official title: Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago: Prospective Multicentric , Double-Blinded, Randomized of the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration
The specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
- Being tested
- corticoid (altim® 1.5 ml), physiological solution (1.5 ml)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticoid (altim® 1.5 ml)Drug
Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
physiological solution (1.5 ml)Drug
Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
| Study group | Role | What they receive |
|---|---|---|
| corticoid | Experimental | Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml) Receives: Drug: corticoid (altim® 1.5 ml) |
| physiological solution | Placebo comparator | Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml) Receives: Drug: physiological solution (1.5 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
To determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
Measured: week 4
Secondary outcomes (3)
To determine whether the improvement by the infiltration of corticoid is present at visit J7 (visit 7 days after the infiltration) and at visit S12 (visit 12 weeks after the infiltration)
To determine whether an anesthetic positif bloc (decrease of the pain of more than 75 % during the hour that follows the infiltration) is a predictive factor of the final result
To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: after 4 years of recruitment only 16 patients have been included. Due to this low rate of recruitment it was decided to stop the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206699
- Sponsor's protocol ID
- 10/3-N
- Status last verified
- Sep 2010
- First submitted
- 21 Sep 2010
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago: Prospective Multicentric , Double-Blinded, Randomized of the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration
- ClinicalTrials.gov ID
- NCT01206699
- Acronym / sponsor ID
- 10/3-N
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: after 4 years of recruitment only 16 patients have been included. Due to this low rate of recruitment it was decided to stop the study
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Sep 2010 (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 specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corticoid | Experimental | Drug: corticoid (altim® 1.5 ml)Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml) |
| physiological solution | Placebo comparator | Drug: physiological solution (1.5 ml)Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult with age equal or above to 18.
- Subject affiliated to French health insurance (Sécurité Sociale)
- Lateralized lumbago on side of the neo-articulation evolving since more than 3 months
- Mechanical pain, lumbar low level or gluteal without sciatic irradiation (pain above the knee)
- Mean pain during the latest 24 hours above 4 on an analogic visual scale (from 0 to 10)- Pain induced by palpation in regards to the neo-articulation
Key exclusion criteria (11 listed)
- Age below 18
- Clinical arguments in favour of a discal origin
- Pregnant women or women that could become pregnant the day of the infiltration
- Diabetic patient
- Patient unable to understand the protocol
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 |
|---|---|---|
| corticoid (altim® 1.5 ml)Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml) | Drug | corticoid |
| physiological solution (1.5 ml)Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml) | Drug | physiological solution |
Primary outcome
To determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
Time frame: week 4
To determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)
3 secondary outcomes
To determine whether the improvement by the infiltration of corticoid is present at visit J7 (visit 7 days after the infiltration) and at visit S12 (visit 12 weeks after the infiltration)
To determine whether an anesthetic positif bloc (decrease of the pain of more than 75 % during the hour that follows the infiltration) is a predictive factor of the final result
To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap
Results and safety
The study was stopped early (reason given: after 4 years of recruitment only 16 patients have been included. Due to this low rate of recruitment it was decided to stop the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing corticoid (altim® 1.5 ml) and physiological solution (1.5 ml) in people with Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation), run by Nantes University Hospital 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Nov 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: after 4 years of recruitment only 16 patients have been included. Due to this low rate of recruitment it was decided to stop the 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?
To determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration) (time frame: week 4). 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 3 Nov 2015.