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Apophysitis; JuvenilePhase 2NCT03606980

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

A Phase 2 study testing Dexamethasone Sodium Phosphate, Iontophoresis and Physical Therapy in people with Apophysitis; Juvenile, run by Children's Health System, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Apophysitis; Juvenile
What is being tested?
Dexamethasone Sodium Phosphate, Iontophoresis and Physical Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
5 sitesUnited States
Study dates
5 Nov 2018to 1 Mar 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • CHKD Sports Medicine Physical Therapy - Oakbrooke

    Chesapeake, Virginia, 23320

  • CHKD Sports Medicine Physical Therapy - Tech Center

    Newport News, Virginia, 23602

  • CHKD Sports Medicine Physicial Therapy - Ghent

    Norfolk, Virginia, 23507

  • CHKD Sports Medicine Physical Therapy - Loehmann's Plaza

    Virginia Beach, Virginia, 23452

  • CHKD Sports Medicine Physical Therapy - Landstown

    Virginia Beach, Virginia, 23456

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Dexamethasone Sodium Phosphate, Iontophoresis, Physical Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone Sodium PhosphateDrug

    Dexamethasone sodium phosphate administered via iontophoresis

  • IontophoresisProcedure or surgery

    Iontophoresis on affected knee

  • Physical TherapyProcedure or surgery

    Physical therapy of affected knee

Study groups in NCT03606980
Study groupRoleWhat they receive
Iontophoresis with DexamethasoneExperimentalIontophoresis 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.
Receives: Drug: Dexamethasone Sodium Phosphate; Procedure: Iontophoresis; Procedure: Physical Therapy
Iontophoresis with Sodium ChloridePlacebo comparatorIontophoresis 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.
Receives: Procedure: Iontophoresis; Procedure: Physical Therapy
Physical Therapy aloneActive comparatorParticipants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits.
Receives: Procedure: Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (4)

  1. Patient Reported Outcome - Percent Difficulty With Activities as Measured by the Lower Extremity Function Scale (LEFS)

    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. The LEFS data is reported as a percentage, calculated as XX points/80 * 100.

    Measured: Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner

  2. 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. A higher score indicates higher levels of physical activity at baseline, thus would be considered a better outcome. The minimum possible score is 0, and there is no defined maximum score, as scores are based on patient's self-reported quantitative activity level, but scores of 24 and above indicate the highest levels of physical activity.

    Measured: Measured at Study Treatment Visit 1 to establish baseline activity level (prior to onset of injury/pain)

  3. 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".

    Measured: Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner

  4. Number of Participants With Adverse Events

    All adverse events that occur during participation in this research study, whether or not considered intervention-related, will be collected.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study start5 Nov 2018
  3. Primary completion22 Dec 2021
  4. Study completion1 Mar 2023

Why it stopped: Slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606980
Sponsor's protocol ID
CHKDSM-001
Status last verified
Feb 2024
First submitted
29 Jun 2018
Last updated
6 Mar 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gholve PA, Scher DM, Khakharia S, Widmann RF, Green DW. Osgood Schlatter syndrome. Curr Opin Pediatr. 2007 Feb;19(1):44-50. doi: 10.1097/MOP.0b013e328013dbea.

    PubMed 17224661

  • Maffulli N, Longo UG, Spiezia F, Denaro V. Sports injuries in young athletes: long-term outcome and prevention strategies. Phys Sportsmed. 2010 Jun;38(2):29-34. doi: 10.3810/psm.2010.06.1780.

    PubMed 20631461

  • Circi E, Atalay Y, Beyzadeoglu T. Treatment of Osgood-Schlatter disease: review of the literature. Musculoskelet Surg. 2017 Dec;101(3):195-200. doi: 10.1007/s12306-017-0479-7. Epub 2017 Jun 7.

    PubMed 28593576

  • Kujala UM, Kvist M, Heinonen O. Osgood-Schlatter's disease in adolescent athletes. Retrospective study of incidence and duration. Am J Sports Med. 1985 Jul-Aug;13(4):236-41. doi: 10.1177/036354658501300404.

    PubMed 4025675

  • Joshi A, Stagni G, Cleary A, Patel K, Weiss DS, Hagins M. Iontophoresis successfully delivers dexamethasone sodium phosphate to dermis as measured by microdialysis. J Pharm Sci. 2014 Jan;103(1):191-6. doi: 10.1002/jps.23771. Epub 2013 Nov 6.

    PubMed 24338751

  • Nirschl RP, Rodin DM, Ochiai DH, Maartmann-Moe C; DEX-AHE-01-99 Study Group. Iontophoretic administration of dexamethasone sodium phosphate for acute epicondylitis. A randomized, double-blinded, placebo-controlled study. Am J Sports Med. 2003 Mar-Apr;31(2):189-95. doi: 10.1177/03635465030310020601.

    PubMed 12642251

  • Runeson L, Haker E. Iontophoresis with cortisone in the treatment of lateral epicondylalgia (tennis elbow)--a double-blind study. Scand J Med Sci Sports. 2002 Jun;12(3):136-42. doi: 10.1034/j.1600-0838.2002.02142.x.

    PubMed 12135445

  • Amirjani N, Ashworth NL, Watt MJ, Gordon T, Chan KM. Corticosteroid iontophoresis to treat carpal tunnel syndrome: a double-blind randomized controlled trial. Muscle Nerve. 2009 May;39(5):627-33. doi: 10.1002/mus.21300.

    PubMed 19347928

  • Neeter C, Thomee R, Silbernagel KG, Thomee P, Karlsson J. Iontophoresis with or without dexamethazone in the treatment of acute Achilles tendon pain. Scand J Med Sci Sports. 2003 Dec;13(6):376-82. doi: 10.1046/j.1600-0838.2003.00305.x.

    PubMed 14617059

  • 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

  • Dhote V, Bhatnagar P, Mishra PK, Mahajan SC, Mishra DK. Iontophoresis: a potential emergence of a transdermal drug delivery system. Sci Pharm. 2012 Jan-Mar;80(1):1-28. doi: 10.3797/scipharm.1108-20. Epub 2011 Dec 13.

    PubMed 22396901

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone Sodium Phosphate, Iontophoresis and Physical Therapy in people with Apophysitis; Juvenile, run by Children's Health System, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606980, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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