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Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Azad University of Medical Sciences

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Drug: Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting Phase 4

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
Study Start Date : January 2003
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. visual analogue scale (VAS)

Secondary Outcome Measures :
  1. Patient's satisfaction


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00554476


Locations
Iran, Islamic Republic of
Azad University of Medical Sciences, Boo-Ali Hospital
Tehran, Iran, Islamic Republic of, 13456/7889
Sponsors and Collaborators
Azad University of Medical Sciences
Investigators
Principal Investigator: Jaleh Hassanloo, MD Department of Orthopedics, Boo-Ali Hospital

ClinicalTrials.gov Identifier: NCT00554476     History of Changes
Other Study ID Numbers: RCT-246910-06
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: November 7, 2007
Last Verified: November 2007

Keywords provided by Azad University of Medical Sciences:
Lateral Epicondylitis
Treatment
Corticosteroid
Elbow Cast
Icing
NSAIDs

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Indomethacin
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents