Clinical trial NCT00437762: Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tennis Elbow
Keywords: Lateral epicondylitis, tennis elbow, treatment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2007-02-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

Eligibility criteria: 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

Primary outcomes:
measure: Principal criteria of assessment is pain intensity three months after injection.
timeFrame: at 3 month
Secondary outcomes:
measure: pain intensity
timeFrame: to day 30, 90,180, 365
measure: Number of painful days
timeFrame: to day 30, 90,180, 365
measure: Number of associated treatments.
timeFrame: to day 30, 90,180, 365
measure: Free pain grip strength
timeFrame: to day 30, 90,180, 365
measure: Rate of recidivism after initial relief
timeFrame: to day 30, 90,180, 365
Other outcomes:
Locations:
city: Bordeaux cedex
country: France
facility: Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.
Study officials:
affiliation: University Hospital, Bordeaux
name: Mathieu DE SEZE, MD
role: PRINCIPAL_INVESTIGATOR
References: