NCT00437762

Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.

Detailed description

* Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months.. * Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection * Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection. * Inclusion criteria : tennis elbow during more than 6 months ; signature of consent * Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism * Study plan: randomized parallel groups * Number of subjects : 60

Conditions

• Tennis Elbow

Interventions

Type	Name	Description
DRUG	Botulinum Toxin A Injection	Botulinum Toxin A Injection
DRUG	Placebo injection	Placebo Injection

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2007-02-21
• Last updated: 2013-02-28

Locations

1 site across 1 country: France