Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

NCT ID: NCT00554476

Last Updated: 2007-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-04-30

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Lateral Epicondylitis

Keywords

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Lateral Epicondylitis Treatment Corticosteroid Elbow Cast Icing NSAIDs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azad University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Jaleh Hassanloo, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, Boo-Ali Hospital

Locations

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Azad University of Medical Sciences, Boo-Ali Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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RCT-246910-06

Identifier Type: -

Identifier Source: org_study_id