Official Title: “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).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

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).

Intervention(s) in this Clinical Trial

• Drug: Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting

Primary Measures

• visual analogue scale (VAS)

Secondary Measures

• Patient's satisfaction

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Azad University of Medical Sciences

Overall Clinical Trial Officials and Contacts

Jaleh Hassanloo, MD Principal Investigator Department of Orthopedics, Boo-Ali Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00554476

Study ID Number: RCT-246910-06

ClinicalTrials.gov Identifier: NCT00554476

Health Authority: Iran: Ministry of Health