Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

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. Identifier: NCT00554476
Recruitment Status : Terminated (Because the sample volume was completed during three years.)
First Posted : November 7, 2007
Last Update Posted : November 7, 2007
Information provided by:
Azad University of Medical Sciences

November 5, 2007
November 7, 2007
November 7, 2007
January 2003
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visual analogue scale (VAS)
Same as current
No Changes Posted
Patient's satisfaction
Same as current
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Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
To compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (NSAIDs).

Design: Randomized clinical trial. Setting: Boo-Ali and Baqyiatallah Hospital in Tehran. Patients: 50 randomly selected patients, in two groups of 25 subjects. Interventions: Corticosteroid injections with elbow cast versus icing and NSAIDs.

Outcome measures: Patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. We measured the pain severity by Visual Analogue Scale (VAS).

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lateral Epicondylitis
Drug: Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2006
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Inclusion Criteria:

  • pain at the lateral side of the elbow
  • pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint
  • pain to be continued for longer than 6 weeks or even with recurrent pain during similar period

Exclusion Criteria:

  • previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention
  • patients who were unable to return for follow up
  • patients with nerve entrapment
  • pregnancy
  • breast-feeding
  • presence of systemic neuromuscular disorders such as myasthenia gravis
  • upper limb fractures
  • other arm/forearm pathology such as radial nerve compression
  • known thrombocytopenia
  • coagulopathy or bleeding diathesis
  • history of diffuse pain syndrome
  • history of inflammatory arthropathy
  • intolerance/allergy to corticosteroids or NSAIDs or any contraindication for these
  • untreated depression
  • history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
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Azad University of Medical Sciences
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Principal Investigator: Jaleh Hassanloo, MD Department of Orthopedics, Boo-Ali Hospital
Azad University of Medical Sciences
November 2007

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