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

Stopped early · Phase 2

Conditions studied: Apophysitis; Juvenile

In brief

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.

Key facts

Study ID: NCT03606980
Run by: Children's Health System, Inc.
People needed: 45
Starts: 2018-11-05
Expected to finish: 2023-03-01
Last updated by the study team: 2024-03-06

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

CHKD Sports Medicine Physical Therapy - Oakbrooke — Chesapeake, Virginia, United States
CHKD Sports Medicine Physical Therapy - Tech Center — Newport News, Virginia, United States
CHKD Sports Medicine Physicial Therapy - Ghent — Norfolk, Virginia, United States
CHKD Sports Medicine Physical Therapy - Loehmann's Plaza — Virginia Beach, Virginia, United States
CHKD Sports Medicine Physical Therapy - Landstown — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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