Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

Tennis Elbow Clinical Trial

— TBA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437762
• Other study ID #: CHUBX 2005/08
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2007
• Last updated: February 27, 2013
• Start date: April 2007
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Drug:
• Botulinum Toxin A Injection
Botulinum Toxin A Injection
• Placebo injection
Placebo Injection

Locations

Country	Name	City	State
France	Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.	Bordeaux cedex

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Principal criteria of assessment is pain intensity three months after injection.		at 3 month	No
Secondary	pain intensity		to day 30, 90,180, 365	No
Secondary	Number of painful days		to day 30, 90,180, 365	No
Secondary	Number of associated treatments.		to day 30, 90,180, 365	No
Secondary	Free pain grip strength		to day 30, 90,180, 365	No
Secondary	Rate of recidivism after initial relief		to day 30, 90,180, 365	No