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Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis

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ClinicalTrials.gov Identifier: NCT00257634
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : April 27, 2007
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Work Related Injury Drug: dexamethasone to injury site Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dexamethasone Delivery for Treatment of Lateral Epicondylitis (IRB #3260)
Study Start Date : December 2004
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. outcome measurement instrument
  2. grip strength
  3. return to work

Secondary Outcome Measures :
  1. cost

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257634

United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Birch Point Medical
Principal Investigator: aamir siddiqui, MD Henry Ford Health System
More Information

ClinicalTrials.gov Identifier: NCT00257634     History of Changes
Other Study ID Numbers: HFHS-3260
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by Henry Ford Health System:
lateral epicondylitis

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action