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

• Status: Recruiting
• Trial end date: 2022-08-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Health System, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Written approval from the referring physician for potential subject to be considered for enrollment into this study

2. Provision of signed and dated informed consent form

3. Stated willingness to comply with all study procedures and availability for the duration of the study

4. In good general health as evidenced by written approval from referring physician for potential inclusion in study.

5. 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

6. 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

7. Able and willing to complete iontophoresis treatments within eight (8) weeks of first treatment

8. Must be ambulatory

9. 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)

10. 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:

1. Pre-menarcheal

2. Within two (2) year post onset of menses

11. Males or females over the age of 14 only with radiographic evidence of skeletal immaturity, with images taken within 90 days of enrollment

12. Index knee symptomatic for pain with activities of daily living or while playing sports.

Exclusion Criteria:

1. Index knee symptomatic for pain only with palpation and not with activities of daily living or while playing sport

2. Diagnosis of bilateral apophysitis of the knee where both knees meet all of the inclusion criteria

3. Systemic fungal infections

4. Has an implanted electronic device

5. Has a known sensitivity to DSP

6. Presence of damaged skin, denuded skin, or other recent scar tissue on index knee

7. Presence of active dermatologic conditions in the affected area (e.g., eczema, psoriasis)

8. Presence of an abnormal neurological exam that indicates the subject would have a reduced ability to perceive pain (e.g. peripheral neuropathy)

9. Has a known sensitivity to electrical current

10. Is currently taking systemic steroids

11. Has had iontophoresis with DSP treatment within the past 30 days

12. Previously enrolled in this study

13. Currently enrolled in another treatment research study