Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis

Dexamethasone Delivery for Treatment of Lateral Epicondylitis (IRB #3260)

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.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis; Work Related Injury
• Intervention / Treatment: Drug: dexamethasone to injury site

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.

• Study Type: Interventional
• Enrollment: 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
outcome measurement instrument
grip strength
return to work

Secondary Outcome Measures

Outcome Measure
cost

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Birch Point Medical
• Investigators: Principal Investigator: aamir siddiqui, md, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: November 21, 2005
• First Submitted That Met QC Criteria: November 21, 2005
• First Posted (Estimate): November 23, 2005

Study Record Updates

• Last Update Posted (Estimate): April 27, 2007
• Last Update Submitted That Met QC Criteria: April 26, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: dexamethasone; iontophoresis; lateral epicondylitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: HFHS-3260