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

May 11, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 330076
        • Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Botulinum Toxin A Injection
Drug: Botulinum Toxin A Injection
Botulinum Toxin A Injection
Placebo Comparator: 2
Placebo injection
Drug: Placebo injection
Placebo Injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Ipsen

Investigators

  • Principal Investigator: Mathieu DE SEZE, MD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 19, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimated)

February 21, 2007

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2005/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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