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Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Terminated
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting
Sponsored by
Azad University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral Epicondylitis, Treatment, Corticosteroid, Elbow Cast, Icing, NSAIDs

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azad University of Medical Sciences, Boo-Ali Hospital

Outcomes

Primary Outcome Measures

visual analogue scale (VAS)

Secondary Outcome Measures

Patient's satisfaction

Full Information

First Posted
November 5, 2007
Last Updated
November 5, 2007
Sponsor
Azad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00554476
Brief Title
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis
Official Title
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
Because the sample volume was completed during three years.
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Azad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Lateral Epicondylitis, Treatment, Corticosteroid, Elbow Cast, Icing, NSAIDs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting
Primary Outcome Measure Information:
Title
visual analogue scale (VAS)
Secondary Outcome Measure Information:
Title
Patient's satisfaction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaleh Hassanloo, MD
Organizational Affiliation
Department of Orthopedics, Boo-Ali Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azad University of Medical Sciences, Boo-Ali Hospital
City
Tehran
ZIP/Postal Code
13456/7889
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

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