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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00497913
First received: July 6, 2007
Last updated: April 22, 2008
Last verified: April 2008

July 6, 2007
April 22, 2008
August 2007
March 2008   (final data collection date for primary outcome measure)
Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pain score on VAS at maximal grip, at maximal pinch, at rest on VAS [ 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 ]
  • Grip strength, and Pinch strength on beginning of pain sensation [ Time Frame: 4 months ]
  • Maximal grip strength, and pinch strength [ Time Frame: 4 months ]
Complete list of historical versions of study NCT00497913 on ClinicalTrials.gov Archive Site
  • Patients subjective feeling of improvement. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Tenderness on lateral epicondyle [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pain sensation on resisted wrist extension, and passive wrist flexion [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pain-free grip strength, and pinch strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Maximal grip strength, and pinch strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Patients subjective feeling of improvement. [ Time Frame: 4 months ]
Not Provided
Not Provided
 
Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
Not Provided

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tennis Elbow
  • Drug: NaCl 0.9%
  • Drug: Botulinum Toxin A
    Other Name: Dysport
  • Active Comparator: A
    Intervention: Drug: Botulinum Toxin A
  • Placebo Comparator: B
    Intervention: Drug: NaCl 0.9%
Espandar R, Heidari P, Rasouli MR, Saadat S, Farzan M, Rostami M, Yazdanian S, Mortazavi SM. Use of anatomic measurement to guide injection of botulinum toxin for the management of chronic lateral epicondylitis: a randomized controlled trial. CMAJ. 2010 May 18;182(8):768-73. doi: 10.1503/cmaj.090906. Epub 2010 Apr 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00497913
85-02-53-4207
Yes
Not Provided
Tehran University of Medical Sciences
Not Provided
Study Director: Seyed Mohammad J Mortazavi, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP