Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00554476
• Other study ID #: RCT-246910-06
• Status: Terminated
• Phase: Phase 4
• First received: November 5, 2007
• Last updated: November 5, 2007
• Start date: January 2003
• Est. completion date: April 2006

Study information

• Verified date: November 2007
• Source: Azad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Drug:
• Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting

Locations

Country	Name	City	State
Iran, Islamic Republic of	Azad University of Medical Sciences, Boo-Ali Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Azad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale (VAS)
Secondary	Patient's satisfaction