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. )

First Received: November 5, 2007 No Changes Posted

Sponsor:	Azad University of Medical Sciences
Information provided by:	Azad University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00554476

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Elbow Injuries and Disorders

Drug Information available for: Indomethacin Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

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

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

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Disorders of Environmental Origin
Reproductive Control Agents
Hormones
Gout Suppressants
Arm Injuries
Triamcinolone hexacetonide
Triamcinolone Acetonide
Musculoskeletal Diseases
Tocolytic Agents
Sensory System Agents

Therapeutic Uses
Triamcinolone
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Tennis Elbow
Cyclooxygenase Inhibitors
Wounds and Injuries
Triamcinolone diacetate
Enzyme Inhibitors
Cardiovascular Agents
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 09, 2010