Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Iontophoresis With Dexamethasone in Combination With Physical Therapy for the Treatment of Pediatric Patients Diagnosed With Apophysitis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Apophysitis; Juvenile

Intervention / Treatment
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* Drug: Dexamethasone Sodium Phosphate
* Procedure: Iontophoresis
* Procedure: Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written approval from the referring physician for potential subject to be considered for enrollment into this study Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study In good general health as evidenced by written approval from referring physician for potential inclusion in study. Has the ability to effectively identify pain/burns and communicate with the investigators or their parents that they are experiencing pain or burning during treatment Referred to CHKD Sports Medicine PT by CHKD Primary Care Sports Medicine physicians or CHKD Orthopedics physicians with a diagnosis of apophysitis of the knee and with a prescription for standard PT treatment with iontophoresis Able and willing to complete iontophoresis treatments within eight (8) weeks of first treatment Must be ambulatory Males 7 to 14 years of age who have not reached skeletal maturity (skeletal maturity based on referring physician's clinical judgement or as demonstrated via radiograph images taken within 90 days of enrollment) Females 7 to 14 years of age who have not reached skeletal maturity (skeletal maturity based on referring physician's clinical judgement or as demonstrated via radiograph images taken within 90 days of enrollment) and who meet one of the following criteria: Pre-menarcheal Within two (2) year post onset of menses Males or females over the age of 14 only with radiographic evidence of skeletal immaturity, with images taken within 90 days of enrollment Index knee symptomatic for pain with activities of daily living or while playing sports. Exclusion Criteria: Index knee symptomatic for pain only with palpation and not with activities of daily living or while playing sport Diagnosis of bilateral apophysitis of the knee where both knees meet all of the inclusion criteria Systemic fungal infections Has an implanted electronic device Has a known sensitivity to DSP Presence of damaged skin, denuded skin, or other recent scar tissue on index knee Presence of active dermatologic conditions in the affected area (e.g., eczema, psoriasis) Presence of an abnormal neurological exam that indicates the subject would have a reduced ability to perceive pain (e.g. peripheral neuropathy) Has a known sensitivity to electrical current Is currently taking systemic steroids Has had iontophoresis with DSP treatment within the past 30 days Previously enrolled in this study Currently enrolled in another treatment research study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iontophoresis with Dexamethasone<br>Iontophoresis is a non-invasive delivery mechanism for transmitting a medication to a local area of the body. The I-Bresis™ System and I-Bresis™ Patch will be the delivery system used for this study. The I-Bresis™ Patch is an adhesive patch. 1.5 ml of the dexamethasone sodium phosphate (4ml/1mL) will be placed on one side and 1.5 ml of 0.9% sodium chloride (saline) solution will be placed on the other. Duration of exposure: 123 minutes. Frequency of exposure: twice per week for a total of 12 sessions over a maximum of 8 weeks or until Return to Sport Criteria are met, whichever is sooner. Participants will also receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. | Drug: Dexamethasone Sodium Phosphate<br>* Dexamethasone sodium phosphate administered via iontophoresis<br>Procedure: Iontophoresis<br>* Iontophoresis on affected knee<br>Procedure: Physical Therapy<br>* Physical therapy of affected knee<br>|
| Placebo Comparator: Iontophoresis with Sodium Chloride<br>Iontophoresis is a non-invasive delivery mechanism for transmitting a medication to a local area of the body. The I-Bresis™ System and I-Bresis™ Patch will be the delivery system used for this study. The I-Bresis™ Patch is an adhesive patch. 1.5 ml of 0.9% sodium chloride (saline) solution will be placed on one side and 1.5 ml of 0.9% saline solution will be placed on the other. Duration of exposure: 123 minutes. Frequency of exposure: twice per week for a total of 12 sessions over a maximum of 8 weeks or until Return to Sport Criteria are met, whichever is sooner. Participants will also receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. | Procedure: Iontophoresis<br>* Iontophoresis on affected knee<br>Procedure: Physical Therapy<br>* Physical therapy of affected knee<br>|
| Active Comparator: Physical Therapy alone<br>Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. | Procedure: Physical Therapy<br>* Physical therapy of affected knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome as measured in length of time to meet Return To Sport criteria (measured in days) | The Return To Sport Criteria is met when all items on the Return To Sport Checklist can be successfully achieved. There are no units of measure for any of the criteria listed as they are either achieved/passed or not achieved/failed based on the criteria listed. Once all criteria can be passed, this date is noted. The number of days from Visit 1 to the date when all criteria are achieved is calculated. This outcome is measured in days. | Measured at each Study Treatment Visit for a maximum of 12 Study Treatment Visits over a maximum of 8 weeks or until Return to Sport Criteria are met, whichever is sooner | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome - percent difficulty with activities as measured by the Lower Extremity Function Scale (LEFS) | Subjects will be asked to attend 2 Study Treatments per week for a maximum of 12 treatments over a maximum of 8 weeks or until Return To Sport Criteria are met, whichever is sooner. The LEFS is a patient reported questionnaire that measures difficult of completing 20 activities. The maximum possible score of the LEFS is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function. | Study Treatment Visit 1, 5 and 12 (or after 8 Weeks of treatment or when Return To Sport Criteria are met, whichever is sooner) and again 30-Days after meeting Return To Sport Criteria. | 
| Patient reported outcome - activity level as measured by the Godin Leisure-Time Activity Questionnaire | The Godin Leisure-Time Activity Questionnaire measures physical activity. Scores of 24 and above indicate the individual is Active, scores of 14-23 indicate the individual is Moderately Active, and scores of 14 and below indicate the individual is insufficiently active/sedentary. | Measured at Study Treatment Visit 1 and 30-Days after Return To Sport Criteria are met and 90-Days after Return To Sport Criteria are met. | 
| Patient reported outcome - pain as measured by the Wong-Baker FACES Pain Rating Scale | This scale was created for children to help them communicate their pain. The scale shows a series of faces ranging from a happy face at 0, No hurt to a crying face at 10 Hurts worst. | Measured at each Study Treatment Visit up to 12 Study Treatment Visits over a maximum of 8 weeks or until Return to Sport Criteria are met, whichever is sooner, and again 2-3 days after meeting Return To Sport Criteria. | 
| Safety as measured by the number and intensity of iontophoresis or DSP-related adverse events | All adverse events that occur during participation in this research study, whether or not considered intervention-related, will be collected. | Measured at each Study Treatment Visit (up to 12 Study Treatment Visits over a maximum of 8 weeks or until Return to Sport Criteria are met, whichever is sooner), then again 2 - 3 days, 30 days, and 90 days after Return To Sport Criteria are met. |