Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics
Apophysitis; Juvenile
About this trial
This is an interventional treatment trial for Apophysitis; Juvenile
Eligibility Criteria
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
Sites / Locations
- CHKD Sports Medicine Physical Therapy - Oakbrooke
- CHKD Sports Medicine Physical Therapy - Tech Center
- CHKD Sports Medicine Physicial Therapy - Ghent
- CHKD Sports Medicine Physical Therapy - Loehmann's Plaza
- CHKD Sports Medicine Physical Therapy - Landstown
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Active Comparator
Iontophoresis with Dexamethasone
Iontophoresis with Sodium Chloride
Physical Therapy alone
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.
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.
Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits.