Clinical Trial Results:
ROLE DES NEO-ARTICULATIONS TRANSVERSO-SACREES OU TRANSVERSO-ILIAQUES (ATLS) DANS LES LOMBALGIES CHRONIQUES : ETUDE PROSPECTIVE MULTICENTRIQUE RANDOMISEE EN DOUBLE AVEUGLE DE L’EFFICACITE DES INFILTRATIONS CORTISONEES VERSUS INFILTRATIONS DE SERUM PHYSIOLOGIQUE
Summary
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EudraCT number |
2010-019626-14 |
Trial protocol |
FR |
Global end of trial date |
05 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
01 May 2021
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First version publication date |
01 May 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BRD 10/03-N
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01206699 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
CHU de Nantes
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Sponsor organisation address |
5 allée de l'île Gloriette, Nantes, France, 44000
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Public contact |
Dr Glémarec J, CHU de Nantes, 33 0240084824, bp-prom-regl@chu-nantes.fr
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Scientific contact |
Dr Glémarec J, CHU de Nantes, 33 0240084824, bp-prom-regl@chu-nantes.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Aug 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Feb 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Le but de cette étude est de montrer, en les traitant par une infiltration de corticoïde, que certaines lombalgies chroniques peuvent s’expliquer par la présence d’une néo-articulation.
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Protection of trial subjects |
À 12 semaines l’aveugle était ouvert de manière à proposer au patient restant douloureux et ayant reçu le sérum physiologique, une infiltration de cortivazol en ouvert sous scanner. Il leur était proposé un suivi hors protocole à sept jours, 4 semaines et 12 semaines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Dec 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
This study concerns adults (age > or = 18 years) suffering from lateralized low back pain on the side of the malformation, evolving for more than three months and resistant to analgesics and non-steroidal anti-inflammatory drugs. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 | |||||||||
Arm description |
Anaesthetic block (1 ml of lidocaine 1%) then immediately 1.5 ml of saline solution is injected. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Saline solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intraarticular use
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Dosage and administration details |
It is administered as a single injection. The anesthesia is done shot by shot with lidocaine. When the needle is intra-articular an anesthetic block is made with 1ml of lidocaine. The needle is left in place followed by 1.5 ml of
saline solution injected. Saline solution comes in 10 cc ampoules which are sterilely withdrawn in a graduated syringe.
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Arm title
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Group 2 | |||||||||
Arm description |
Anaesthetic block (1 ml of lidocaine 1%) then immediately 1.5 ml of corticosteroid is injected. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Corticosteroid
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intraarticular use
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Dosage and administration details |
It is administered as a single injection. The anesthesia is done shot by shot with lidocaine. When the needle is intra-articular an anesthetic block is made with 1ml of lidocaine. The needle is left in place followed by 1.5 ml of
corticosteroid injected. The corticosteroid comes in a pre-filled syringe.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Anaesthetic block (1 ml of lidocaine 1%) then immediately 1.5 ml of saline solution is injected. | ||
Reporting group title |
Group 2
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Reporting group description |
Anaesthetic block (1 ml of lidocaine 1%) then immediately 1.5 ml of corticosteroid is injected. |
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End point title |
VAS | |||||||||
End point description |
Difference of the mean VAS of the 24 hours before the infiltration and the mean VAS of the 24 hours before the visit at Week 4.
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End point type |
Primary
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End point timeframe |
Week 4
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Statistical analysis title |
Mean 24-hour VAS pain score | |||||||||
Statistical analysis description |
The primary outcome measure was the difference in the mean 24-hour VAS pain score from baseline to 4 weeks after the injection. Secondary outcome measures were compared using either the non-parametric Wilcoxon test or, for comparisons of baseline values to week 4 or week 12 values in the two treatment groups pooled, the Wilcoxon test for paired data.
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Comparison groups |
Group 2 v Group 1
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Parameter type |
Mean difference (net) | |||||||||
Point estimate |
3
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Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
1 | |||||||||
upper limit |
3 | |||||||||
Variability estimate |
Standard error of the mean
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Adverse events information [1]
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Timeframe for reporting adverse events |
Overall
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
NA
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No serious adverse events were reported. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |