Epicondylitis
Conditions
Keywords
Epicondylitis, Botulinum toxin, Corticoid
Brief summary
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 * demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities. * evaluate tolerance of treatment by grip strength measurement and adverse event collection.
Detailed description
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.
Interventions
DRUGInjection, botulinum toxin + corticoid
* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
DRUGInjection, placebo of toxin + corticoid
* Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
DRUGInjection, botulinum toxin + placebo corticoid
* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Ratio 1:1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged between 18 and 60 years; * Physical disability or not; * Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os; * Signed consent obtained; * Covered by health insurance.
Exclusion criteria
* Central nervous system disorders result in spasticity in epicondylitis limb; * History of severe psychiatric disorder; * History of myasthenia gravis; * Pregnant or breastfeeding woman; * Unable to understand or respond to questions; * Contraindication to botulinum toxin or corticoid; * Treatment with botulinum toxin 3 months prior to baseline; * Anticoagulant theraphy; * Difficult to follow-up in the study; * Patient under guardianship, or deprived of liberty by a judicial order.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of pain intensity between injection of treatment and 6 months after injection | At the moment of 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity of motion of wrist flexion | Before injection, 3 months after injection and 6 months after injection | Evaluate pain intensity of motion of wrist flexion with the VAS. |
| Pain intensity at proximal insertion palpation on epicondylitis muscle | Before injection, 3 months after injection and 6 months after injection | Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control. |
| Number of days of sick leave | 6 months after injection | Number of days of sick leave will be noted and collected |
| The percentage of patients returning to professional activity or sportive activity | 6 months after injection | — |
| Spontaneous pain intensity at rest | Before injection, 3 months after injection and 6 months after injection | Evaluate pain intensity at rest with the VAS. |
| Functional outcome after injection | At baseline, 3 months after injection, 6 months after injection | Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation |
| Anxiety and depression tests | At baseline, 3 months after injection, 6 months after injection | Hospital Anxiety and Depression scale will be used |
| Frequence and gravity of adverse events | At baseline, 3 months after injection, 6 months after injection | Adverse events will be collected and their severity will be reported. |
| Measurement of prehensile grasp capabilities by a force | At baseline, 3 months after injection, 6 months after injection | The force will be measured by Jamar Hydraulic hand dynamometer. |
Countries
France
Outcome results
None listed