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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001709-33 | EudraCT Number |
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The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.
As secondary objectives, the study aims to
This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.
All patients will be randomized in 3 following parallel treatment groups:
Group A : botulinum toxin + corticoid
Group C : placebo of toxin + corticoid
Group T : botulinum toxin + placebo corticoid
The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A : Association (botulinum toxin + corticoid) | Experimental |
| |
| Group C : placebo of toxin + corticoid : | Placebo Comparator |
| |
| Group T : botulinum toxin + placebo corticoid | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection, botulinum toxin + corticoid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of pain intensity between injection of treatment and 6 months after injection | Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the Visual Analogue Scale (VAS). | At the moment of injection |
| Variation of pain intensity between injection of treatment and 6 months after injection | Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the VAS. | 6 months after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous pain intensity at rest | Evaluate pain intensity at rest with the VAS. | Before injection, 3 months after injection and 6 months after injection |
| Pain intensity of motion of wrist flexion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Genêt, MD, PhD | Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré | Garches | Hauts-de-Seine | 92380 | France |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D001905 | Botulinum Toxins |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D008666 | Metalloendopeptidases |
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Ratio 1:1:1
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| Injection, placebo of toxin + corticoid | Drug |
|
|
| Injection, botulinum toxin + placebo corticoid | Drug |
|
|
Evaluate pain intensity of motion of wrist flexion with the VAS.
| Before injection, 3 months after injection and 6 months after injection |
| Pain intensity at proximal insertion palpation on epicondylitis muscle | Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control. | Before injection, 3 months after injection and 6 months after injection |
| Number of days of sick leave | Number of days of sick leave will be noted and collected | 6 months after injection |
| The percentage of patients returning to professional activity or sportive activity | 6 months after injection |
| Measurement of prehensile grasp capabilities by a force | The force will be measured by Jamar Hydraulic hand dynamometer. | At baseline, 3 months after injection, 6 months after injection |
| Functional outcome after injection | Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation | At baseline, 3 months after injection, 6 months after injection |
| Anxiety and depression tests | Hospital Anxiety and Depression scale will be used | At baseline, 3 months after injection, 6 months after injection |
| Frequence and gravity of adverse events | Adverse events will be collected and their severity will be reported. | At baseline, 3 months after injection, 6 months after injection |
| D010450 |
| Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |