Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis
Condition: Lateral Epicondylitis; Work Related Injury
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): dexamethasone to injury site
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lateral epicondylitis; iontophoresis; dexamethasone