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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437762

Acronym

TBA

Enrollment

Registered

2007-02-21

Start date

2007-04-30

Completion date

2012-06-30

Last updated

2013-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tennis Elbow

Keywords

Lateral epicondylitis, tennis elbow, treatment

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

Interventions

DRUGBotulinum Toxin A Injection

Botulinum Toxin A Injection

DRUGPlacebo injection

Placebo Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026