Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics
Condition: Apophysitis; Juvenile
MeSH terms: Osteitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to determine if there is a difference in time to
      meet return to sport criteria for Pediatric patients with apophysitis of the knee who receive
      iontophoresis with Dexamethasone Sodium Phosphate (DSP) and Physical Therapy (PT) as those
      who receive iontophoresis with placebo and PT or PT alone.

      Approximately 147 patients will be enrolled in this study.
    

Detailed description: 
      Iontophoresis is a treatment that allows medication to be delivered across your skin to the
      painful area without having to have an injection into your muscle or soft tissue, through a
      vein in your arm, or taking a pill. Instead, liquid medication is placed on a patch (like a
      large Band-Aid) and then placed on your knee over the location where it hurts. A plastic
      device, like a battery, is then attached to the patch for three minutes. During this time,
      this device begins to deliver the medication through your skin and into the area that hurts,
      and also charges the patch so it can continue to deliver the medication for two hours once
      the device is removed. The medication is delivered by a mild electrical current. The most
      common drug used with iontophoresis for pain caused by such things as apophysitis of the knee
      is dexamethasone sodium phosphate (dexamethasone).

      This is an investigational study. Dexamethasone is a steroid medication that has been
      approved by the U.S Food and Drug Administration (FDA) to treat many types of problems (such
      as joint problems, skin and allergy problems, eye, stomach, and lung problems), but has not
      been approved to treat apophysitis of the knee using iontophoresis. In this study, it is an
      experimental drug.

      Participants will be randomized to one of three treatment groups:

        -  Physical therapy with iontophoresis using Dexamethasone

        -  Physical therapy with iontophoresis using an inactive drug called a placebo

        -  Physical therapy alone

      Participants will be asked to attend study visits twice/week for up to 8 weeks or until they
      are able to pass the Return To Sport Checklist, whichever is sooner. Participants will the
      receive a 30-Day Follow Up phone call and complete a survey at the 90-Day mark, making each
      participant's study duration approximately five (5) months.
    

Intervention name(s): Dexamethasone Sodium Phosphate; Iontophoresis; Physical Therapy
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Dexamethasone sodium phosphate administered via iontophoresis; Iontophoresis on affected knee; Physical therapy of affected knee
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment