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

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ClinicalTrials.gov Identifier: NCT00497913
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : April 23, 2008
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Tennis Elbow Drug: NaCl 0.9% Drug: Botulinum Toxin A Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: Botulinum Toxin A
Other Name: Dysport
Placebo Comparator: B Drug: NaCl 0.9%


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

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

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

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
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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


Locations
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Iran, Islamic Republic of
Imam Khomeini Hospital
Tehran, Iran, Islamic Republic of, 1419173341
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Director: Seyed Mohammad J Mortazavi, M.D. Tehran University of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00497913    
Other Study ID Numbers: 85-02-53-4207
First Posted: July 9, 2007    Key Record Dates
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:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Botulinum Toxins
Botulinum Toxins, Type A
 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