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

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ClinicalTrials.gov Identifier: NCT03606980
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Dana Reesman, DPT, Children's Health System, Inc.

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.


Condition or disease Intervention/treatment Phase
Apophysitis; Juvenile Drug: Dexamethasone Sodium Phosphate Procedure: Iontophoresis Procedure: Physical Therapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Iontophoresis with Dexamethasone
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
Dexamethasone sodium phosphate administered via iontophoresis

Procedure: Iontophoresis
Iontophoresis on affected knee

Procedure: Physical Therapy
Physical therapy of affected knee

Placebo Comparator: Iontophoresis with Sodium Chloride
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
Iontophoresis on affected knee

Procedure: Physical Therapy
Physical therapy of affected knee

Active Comparator: Physical Therapy alone
Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits.
Procedure: Physical Therapy
Physical therapy of affected knee




Primary Outcome Measures :
  1. Functional outcome as measured in length of time to meet Return To Sport criteria (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 ]
    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 :
  1. Patient reported outcome - percent difficulty with activities as measured by the Lower Extremity Function Scale (LEFS) [ 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. ]
    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.

  2. Patient reported outcome - activity level as measured by the Godin Leisure-Time Activity Questionnaire [ 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. ]
    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.

  3. Patient reported outcome - pain as measured by the Wong-Baker FACES Pain Rating Scale [ 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. ]
    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".

  4. Safety as measured by the number and intensity of iontophoresis or DSP-related adverse events [ 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. ]
    All adverse events that occur during participation in this research study, whether or not considered intervention-related, will be collected.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 8 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 8 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606980


Contacts
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Contact: Dana Reesman, PT, DPT 757-668-4894 Dana.Reesman@chkd.org

Locations
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United States, Virginia
CHKD Sports Medicine Physicial Therapy - Ghent Recruiting
Norfolk, Virginia, United States, 23507
Contact: Dana Reesman, PT, DPT         
CHKD Sports Medicine Physical Therapy - Landstown Recruiting
Virginia Beach, Virginia, United States, 23456
Contact: Dana Reesman, PT, DPT         
Sponsors and Collaborators
Children's Health System, Inc.
Investigators
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Principal Investigator: Dana Reesman, PT, DPT Children's Hospital of the Kings Daughters

Publications:
Marovino T, Graves C. Iontophoresis in Pain Management. Practical Pain Management . 2011; 8(2): 1-2. Available from: https://www.practicalpainmanagement.com/treatments/interventional/iontophoresis-pain-management, Accessed May 17, 2018
Dexamethasone sodium phosphate. In: Micromedex Solutions DRUGDEX® System. IBM Watson Health. Ann Arbor, MI. [cited April 22, 2018]. Available from: http://micromedexsolutions.com
Kaur J, Malik M, Sharma P, Sangwan P, Rani M. Effect of iontophoresis with dexamethasone in pain. Indian Journal of Physiotherapy and Occupational Therapy. 2017; 11(3).
Clijsen R, Taeymans J, Baeyens JP, Barl AO, Clarys P. The effects of iontophoresis in the treatment of musculoskeletal disorders - a systematic review and meta-analysis. Drug Delivery Letters. 2012: 2(3).
Goyal M, Kumar A, Mahajan N, Moitra M. Treatment of plantar fasciitis by taping vs. iontophoresis: a randomized clinical trial. Journal of Exercise Science and Physiotherapy. 2013: 9(1):34-39
WHO Physical activity and young people [Internet]. World Health Organization; c2018 [cited 2018 June 20]. Available from: http://www.who.int/dietphysicalactivity/factsheet_young_people/en/
WHO Physical activity [Internet]. World Health Organization; c2018 [cited 2018 June 20]. Available from: http://www.who.int/dietphysicalactivity/pa/en/
I-Bresis™ Charging Station (1360) - Instructions For Use [Internet]. Rev. B 2017 [cited 2018 May 17]. Available from: http://www.djoglobal.com/sites/default/files/Charging%20Station%20IFU.pdf
I-Bresis™ Controller (1361) - Instructions For Use, [Internet]. Rev. B 2017 [cited 2018 May 17]. Available from: http://www.djoglobal.com/sites/default/files/Controller%20IFU.pdf
I-Bresis™ Patch (5000060) - Instructions For Use, [Internet]. Rev. B 2017 [cited 2018 May 17]. Available from: http://www.djoglobal.com/sites/default/files/Electrode%20IFU.pdf
Sodium Chloride Injection, USP [package insert]. Deerfield, IL: Baxter Corporation; 2018 [cited 2018 April 25]. Available from http://baxterpi.com/pi-pdf/Sodium_Chloride_Injection_Viaflex_PI.pdf
2007 Standard Operating Procedures of the Eastern Virginia Medical School Institutional Review Board [Internet]. July 2007 [cited 2018 May 17]. Available from: https://www.evms.edu/media/evms_public/departments/research_administration/research_subjects_protections/2007_EVMS_IRB_SOPs.pdf

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Responsible Party: Dana Reesman, DPT, CHKD Sports Medicine Physical Therapist, Children's Health System, Inc.
ClinicalTrials.gov Identifier: NCT03606980     History of Changes
Other Study ID Numbers: CHKDSM-001
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Osteitis
Bone Diseases
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action