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Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

This study has been terminated.
(Because the sample volume was completed during three years.)
Sponsor:
Information provided by:
Azad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00554476
First received: November 5, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention Phase
Lateral Epicondylitis
 Drug: Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • visual analogue scale (VAS)

Secondary Outcome Measures:
  • Patient's satisfaction

Estimated Enrollment: 50
Study Start Date: January 2003
Estimated Study Completion Date: April 2006
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00554476     History of Changes
Other Study ID Numbers: RCT-246910-06
Study First Received: November 5, 2007
Last Updated: November 5, 2007
Health Authority: Iran: Ministry of Health

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

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Indomethacin
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013