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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437762
First Posted: February 21, 2007
Last Update Posted: February 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Bordeaux
  Purpose
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 Intervention Phase
Tennis Elbow Drug: Botulinum Toxin A Injection Drug: Placebo injection Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Botox Elbow Injuries and Disorders
Drug Information available for: OnabotulinumtoxinA
U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

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

Secondary Outcome Measures:
  • pain intensity [ Time Frame: to day 30, 90,180, 365 ]
  • Number of painful days [ Time Frame: to day 30, 90,180, 365 ]
  • Number of associated treatments. [ Time Frame: to day 30, 90,180, 365 ]
  • Free pain grip strength [ Time Frame: to day 30, 90,180, 365 ]
  • Rate of recidivism after initial relief [ Time Frame: to day 30, 90,180, 365 ]
Enrollment: 61
Study Start Date: April 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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
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

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00437762     History of Changes
Other Study ID Numbers: CHUBX 2005/08
First Submitted: February 19, 2007
First Posted: February 21, 2007
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
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
 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


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