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

This study has been completed.
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00437762
First received: February 19, 2007
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain intensity [ Time Frame: to day 30, 90,180, 365 ] [ Designated as safety issue: No ]
  • Number of painful days [ Time Frame: to day 30, 90,180, 365 ] [ Designated as safety issue: No ]
  • Number of associated treatments. [ Time Frame: to day 30, 90,180, 365 ] [ Designated as safety issue: No ]
  • Free pain grip strength [ Time Frame: to day 30, 90,180, 365 ] [ Designated as safety issue: No ]
  • Rate of recidivism after initial relief [ Time Frame: to day 30, 90,180, 365 ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 19, 2007
Last Updated: February 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
IncobotulinumtoxinA
 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

ClinicalTrials.gov processed this record on September 26, 2016