Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

NCT ID: NCT00437762

Last Updated: 2013-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-06-30

Brief Summary

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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

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* 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

Conditions

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Tennis Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Botulinum Toxin A Injection

Group Type EXPERIMENTAL

Botulinum Toxin A Injection

Intervention Type DRUG

Botulinum Toxin A Injection

2

Placebo injection

Group Type PLACEBO_COMPARATOR

Placebo injection

Intervention Type DRUG

Placebo Injection

Interventions

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Botulinum Toxin A Injection

Botulinum Toxin A Injection

Intervention Type DRUG

Placebo injection

Placebo Injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu DE SEZE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2005/08

Identifier Type: -

Identifier Source: org_study_id

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