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Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis (DCLE)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 9, 2007
Last Update Posted: April 23, 2008
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.
Information provided by:
Tehran University of Medical Sciences
The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.

Condition Intervention Phase
Tennis Elbow Drug: NaCl 0.9% Drug: Botulinum Toxin A Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Patients subjective feeling of improvement. [ Time Frame: 4 months ]
  • Tenderness on lateral epicondyle [ Time Frame: 4 months ]
  • Pain sensation on resisted wrist extension, and passive wrist flexion [ Time Frame: 4 months ]
  • Pain-free grip strength, and pinch strength [ Time Frame: 4 months ]
  • Maximal grip strength, and pinch strength [ Time Frame: 4 months ]

Estimated Enrollment: 52
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Botulinum Toxin A
Other Name: Dysport
Placebo Comparator: B Drug: NaCl 0.9%

Detailed Description:
Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis.
  • Symptom duration: should be at least 6 months.
  • Previous trial of complete course of physiotherapy and corticosteroid injection.

Exclusion Criteria:

  • Rheumatoid arthritis
  • Generalized polyarthritis
  • Local elbow arthritis
  • Simultaneous medial epicondylalgia
  • Bilateral lateral epicondylitis
  • Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality, radicular pain, radial nerve entrapment, signs of nerve root compression, decreased muscle force, multiple sclerosis, seizures)
  • The use of corticosteroid in last 30 days
  • Simultaneous use of drugs other than acetaminophen or physical therapy in the course of study
  • Pregnancy
  • Breast-feeding
  • Previous hand surgery
  • Having a hobby or job that needs finger extension
  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): NCT00497913

Iran, Islamic Republic of
Imam Khomeini Hospital
Tehran, Iran, Islamic Republic of, 1419173341
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Director: Seyed Mohammad J Mortazavi, M.D. Tehran University of Medical Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00497913     History of Changes
Other Study ID Numbers: 85-02-53-4207
First Submitted: July 6, 2007
First Posted: July 9, 2007
Last Update Posted: April 23, 2008
Last Verified: April 2008

Keywords provided by Tehran University of Medical Sciences:
Tennis Elbow
Botulinum Toxin

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Botulinum Toxins
Botulinum Toxins, Type A
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