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

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ClinicalTrials.gov Identifier: NCT00437762
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : February 28, 2013
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Drug: Botulinum Toxin A Injection Drug: Placebo injection Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: 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 Start Date : April 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Principal criteria of assessment is pain intensity three months after injection. [ Time Frame: at 3 month ]

Secondary Outcome Measures :
  1. pain intensity [ Time Frame: to day 30, 90,180, 365 ]
  2. Number of painful days [ Time Frame: to day 30, 90,180, 365 ]
  3. Number of associated treatments. [ Time Frame: to day 30, 90,180, 365 ]
  4. Free pain grip strength [ Time Frame: to day 30, 90,180, 365 ]
  5. Rate of recidivism after initial relief [ Time Frame: to day 30, 90,180, 365 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437762


Locations
France
Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.
Bordeaux cedex, France, 330076
Sponsors and Collaborators
University Hospital, Bordeaux
Ipsen
Investigators
Principal Investigator: Mathieu DE SEZE, MD University Hospital, Bordeaux
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00437762     History of Changes
Other Study ID Numbers: CHUBX 2005/08
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Keywords provided by University Hospital, Bordeaux:
Lateral epicondylitis, tennis elbow, treatment

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Botulinum Toxins
Botulinum Toxins, Type A
 onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents