Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment (TBA)

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Tennis Elbow

Treatments: Drug: Botulinum Toxin A Injection; Drug: Placebo injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00437762

CHUBX 2005/08

Details and patient eligibility

About

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.

Full 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

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Botulinum Toxin A Injection

Treatment:

Drug: Botulinum Toxin A Injection

2

Placebo Comparator group

Description:

Placebo injection

Treatment:

Drug: Placebo injection