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Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis

This study has been completed.
Sponsor:
Collaborator:
Birch Point Medical
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00257634
First received: November 21, 2005
Last updated: April 26, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Lateral Epicondylitis
Work Related Injury
Drug: dexamethasone to injury site
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dexamethasone Delivery for Treatment of Lateral Epicondylitis (IRB #3260)

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • outcome measurement instrument
  • grip strength
  • return to work

Secondary Outcome Measures:
  • cost

Estimated Enrollment: 80
Study Start Date: December 2004
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257634

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

No publications provided

ClinicalTrials.gov Identifier: NCT00257634     History of Changes
Other Study ID Numbers: HFHS-3260
Study First Received: November 21, 2005
Last Updated: April 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
lateral epicondylitis
iontophoresis
dexamethasone

Additional relevant MeSH terms:
Tennis Elbow
Arm Injuries
Musculoskeletal Diseases
Wounds and Injuries
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014