Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

Phase 3

Completed

• Conditions: Tennis Elbow
• Interventions: Drug: Botulinum Toxin A Injection; Drug: Placebo injection

• Registration Number: NCT00437762
• Lead Sponsor: University Hospital, Bordeaux

Brief 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

Study Timeline

• Study First Submitted: 2007-02-19
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Study Start: 2007-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Tennis elbow during more than 6 months
• Signature of consent

Exclusion Criteria

• Less than 18 years old
• Osteoarthritis elbow
• Referred cervical pain
• Fibromyalgia
• Pregnancy
• Myasthenia
• Polymyositis
• SLA
• Anticoagulant treatment
• Aminosides
• Diabetes
• Alcoholism
• Previous botulinum toxin A injections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Botulinum Toxin A Injection	Botulinum Toxin A Injection
2	Placebo injection	Placebo injection

Primary Outcome Measures

Name	Time	Method
Principal criteria of assessment is pain intensity three months after injection.	at 3 month

Secondary Outcome Measures

Name	Time	Method
Number of painful days	to day 30, 90,180, 365
Number of associated treatments.	to day 30, 90,180, 365
Rate of recidivism after initial relief	to day 30, 90,180, 365
pain intensity	to day 30, 90,180, 365
Free pain grip strength	to day 30, 90,180, 365

Trial Locations

Locations (1)

Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.; 🇫🇷 Bordeaux cedex, France