Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment — TBA  

Tennis Elbow Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

• NCT number: NCT00437762
• Study type: Interventional
• Source: University Hospital, Bordeaux
• Status: Completed
• Phase: Phase 3
• Start date: April 2007
• Completion date: June 2012