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

Primary Purpose

Apophysitis; Juvenile

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Sodium Phosphate
Iontophoresis
Physical Therapy
Sponsored by
Children's Health System, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apophysitis; Juvenile

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Iontophoresis with Dexamethasone

Iontophoresis with Sodium Chloride

Physical Therapy alone

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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".
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.

Full Information

First Posted
June 29, 2018
Last Updated
August 29, 2023
Sponsor
Children's Health System, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03606980
Brief Title
Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Health System, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apophysitis; Juvenile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iontophoresis with Dexamethasone
Arm Type
Experimental
Arm Description
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.
Arm Title
Iontophoresis with Sodium Chloride
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Physical Therapy alone
Arm Type
Active Comparator
Arm Description
Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Sodium Phosphate
Intervention Description
Dexamethasone sodium phosphate administered via iontophoresis
Intervention Type
Procedure
Intervention Name(s)
Iontophoresis
Intervention Description
Iontophoresis on affected knee
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Physical therapy of affected knee
Primary Outcome Measure Information:
Title
Functional outcome as measured in length of time to meet Return To Sport criteria (measured in days)
Description
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.
Time Frame
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 Measure Information:
Title
Patient reported outcome - percent difficulty with activities as measured by the Lower Extremity Function Scale (LEFS)
Description
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.
Time Frame
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.
Title
Patient reported outcome - activity level as measured by the Godin Leisure-Time Activity Questionnaire
Description
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.
Time Frame
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.
Title
Patient reported outcome - pain as measured by the Wong-Baker FACES Pain Rating Scale
Description
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".
Time Frame
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.
Title
Safety as measured by the number and intensity of iontophoresis or DSP-related adverse events
Description
All adverse events that occur during participation in this research study, whether or not considered intervention-related, will be collected.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Reesman, PT, DPT
Organizational Affiliation
Children's Hospital of the Kings Daughters
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHKD Sports Medicine Physical Therapy - Oakbrooke
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
CHKD Sports Medicine Physical Therapy - Tech Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
CHKD Sports Medicine Physicial Therapy - Ghent
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
CHKD Sports Medicine Physical Therapy - Loehmann's Plaza
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
CHKD Sports Medicine Physical Therapy - Landstown
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics

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