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Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis, Work Related Injury

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
dexamethasone to injury site
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylitis, iontophoresis, dexamethasone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Tenderness at lateral epicondyle, No radiographic abnormality at the elbow, Mille's Sign positive- pain with elbow extension, Forearm pronation, Wrist flexion, Maudsley Test positive - pain with resisted passive Exclusion Criteria: Pregnancy, History of fibromyalgia, Elbow surgery, Diagnosis of multilevel nerve compression, Symptoms of lateral epicondylitis for more than 2 year, Bilateral lateral epicondylitis, Previous corticosteroid injection in the same elbow, Use of systemic steroid medication within the last 6 months, Evidence of active infection, History of allergic reaction to the study medication.

Sites / Locations

  • Henry Ford Health System

Outcomes

Primary Outcome Measures

outcome measurement instrument
grip strength
return to work

Secondary Outcome Measures

cost

Full Information

First Posted
November 21, 2005
Last Updated
April 26, 2007
Sponsor
Henry Ford Health System
Collaborators
Birch Point Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00257634
Brief Title
Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis
Official Title
Dexamethasone Delivery for Treatment of Lateral Epicondylitis (IRB #3260)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Henry Ford Health System
Collaborators
Birch Point Medical

4. Oversight

5. Study Description

Brief Summary
The purpose of this project is to compare different treatment options for lateral epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the forearm originating from the lateral epicondyle. Controversy exists regarding the method of delivering pain relief so that conditioning and strengthening can be initiated and progress appropriately. Our hypothesis is that the steady even delivery via iontophoresis (compared to injection will provide better pain control and allow physical therapy to progress more effectively.
Detailed Description
Therapy is standardized so treatment can begin before enrollment in the study. Patients who decide not to participate will get standard therapy. Therapy is based on the published Indiana Hand Center protocol. Phase 1 is rest, phase 2 is mobility and phase 3 is strengthening. Patients who agree to participate will be randomized to either the injection or iontopatch group after informed consent. GROUP 1 (injection) Patients seen by physician. Based upon history and physical examination, injection wil be offered. Injection is 10 mg dexamethasone intramuscular. Therapy then is continued per standard protocol. Patient monitored for worsening of symptoms. If the patient worsens, the patient will be placed back into phase 1 and 2 for another 3 weeks then advanced again. Repeat injection will be at discretion of the treating physician. Patients with more than 2 injections wil be disqualified from the study and considered a treatment failure. Patients that injections wil be disqualified from the study and considered a treatment failure. Patients that completed phase 3 will be released from therapy with home management program instructions. Restrictions will be at the discretion of the physician. After 2 failures to progress to phase 3, the patient will be considered a failure of treatment. In the event of relapse after successful completion of therapy, the protocol will be repeated. GROUP 2 (iontopatch) One volt patch with dexamethasone phosphate will be used.Patient will be treated with one patch every 2 days for a total of 3 patches. Application will be per the Birchpoint Medical Group Iontopatch 80 protocol. The patches will correlate with physical therapy phases 1 and 2. Phase 3 will not begin until the Iontopatch has been off for more than 24 hours. Therapy will progress based on the above protocol. If there is worsening of symptoms, the patient will be placed back to phase 1 and 2 for another 3 weeks and then advanced again. Iontopatches can be repeated if there has been a substantial worsening of symptoms. Patients are eligible for up to 6 patches for the duration of the study. Once the 6 patches have been used, therapy can continue per protocol but without iontopatch and/or injection. Patients that completed phase 3 will be released from therapy. After 2 failures to progress to phase 3, the patient will be considered a failure of treatment. Long term restrictions will be at the discretion of the physician. Patients will complete a Forearm Pain Questionnaire at the time of enrollment, at completion of therapy and monthly after that for 3 months. This is a standardized published questionnaire specifically designed to identify and track lateral epicondylitis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Work Related Injury
Keywords
lateral epicondylitis, iontophoresis, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dexamethasone to injury site
Primary Outcome Measure Information:
Title
outcome measurement instrument
Title
grip strength
Title
return to work
Secondary Outcome Measure Information:
Title
cost

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Tenderness at lateral epicondyle, No radiographic abnormality at the elbow, Mille's Sign positive- pain with elbow extension, Forearm pronation, Wrist flexion, Maudsley Test positive - pain with resisted passive Exclusion Criteria: Pregnancy, History of fibromyalgia, Elbow surgery, Diagnosis of multilevel nerve compression, Symptoms of lateral epicondylitis for more than 2 year, Bilateral lateral epicondylitis, Previous corticosteroid injection in the same elbow, Use of systemic steroid medication within the last 6 months, Evidence of active infection, History of allergic reaction to the study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
aamir siddiqui, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis

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