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

NCT03606980 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CHKDSM-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Apophysitis; Juvenile

Outcome Measures

Primary Outcomes (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 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)

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

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

• Patient Reported Outcome - Activity Level as Measured by the Godin Leisure-Time Activity Questionnaire

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

• Patient Reported Outcome - Pain as Measured by the Wong-Baker FACES Pain Rating Scale

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

• Number of Participants With Adverse Events

  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.

Study Arms (3)

Iontophoresis with Dexamethasone

EXPERIMENTAL

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; Procedure: Iontophoresis; Procedure: Physical Therapy

Iontophoresis with Sodium Chloride

PLACEBO COMPARATOR

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; Procedure: Physical Therapy

Physical Therapy alone

ACTIVE COMPARATOR

Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits.

Procedure: Physical Therapy

Interventions

Dexamethasone Sodium Phosphate DRUG

Dexamethasone sodium phosphate administered via iontophoresis

Iontophoresis with Dexamethasone

Iontophoresis PROCEDURE

Iontophoresis on affected knee

Iontophoresis with Dexamethasone; Iontophoresis with Sodium Chloride

Physical Therapy PROCEDURE

Physical therapy of affected knee

Iontophoresis with Dexamethasone; Iontophoresis with Sodium Chloride; Physical Therapy alone

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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
• 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
• 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

Sponsors & Collaborators

• Children's Health System, Inc.: lead

Study Sites (5)

CHKD Sports Medicine Physical Therapy - Oakbrooke

Chesapeake, Virginia, 23320, United States

Location

CHKD Sports Medicine Physical Therapy - Tech Center

Newport News, Virginia, 23602, United States

Location

CHKD Sports Medicine Physicial Therapy - Ghent

Norfolk, Virginia, 23507, United States

Location

CHKD Sports Medicine Physical Therapy - Loehmann's Plaza

Virginia Beach, Virginia, 23452, United States

Location

CHKD Sports Medicine Physical Therapy - Landstown

Virginia Beach, Virginia, 23456, United States

Location

Related Publications (25)

• 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.

  PMID: 17224661 BACKGROUND

• 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.

  PMID: 20631461 BACKGROUND

• 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.

  PMID: 28593576 BACKGROUND

• 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.

  PMID: 4025675 BACKGROUND

• 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.

  PMID: 24338751 BACKGROUND

• 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.

  PMID: 12642251 BACKGROUND

• 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.

  PMID: 12135445 BACKGROUND

• 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.

  PMID: 19347928 BACKGROUND

• 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.

  PMID: 14617059 BACKGROUND

• 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

  BACKGROUND

• Dexamethasone sodium phosphate. In: Micromedex Solutions DRUGDEX® System. IBM Watson Health. Ann Arbor, MI. [cited April 22, 2018]. Available from: http://micromedexsolutions.com

  BACKGROUND

• 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.

  PMID: 22396901 BACKGROUND

• 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).

  BACKGROUND

• 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).

  BACKGROUND

• 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

  BACKGROUND

• Mina R, Melson P, Powell S, Rao M, Hinze C, Passo M, Graham TB, Brunner HI. Effectiveness of dexamethasone iontophoresis for temporomandibular joint involvement in juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2011 Nov;63(11):1511-6. doi: 10.1002/acr.20600.

  PMID: 22034112 BACKGROUND

• Stefanou A, Marshall N, Holdan W, Siddiqui A. A randomized study comparing corticosteroid injection to corticosteroid iontophoresis for lateral epicondylitis. J Hand Surg Am. 2012 Jan;37(1):104-9. doi: 10.1016/j.jhsa.2011.10.005.

  PMID: 22196293 BACKGROUND

• Vaishya R, Azizi AT, Agarwal AK, Vijay V. Apophysitis of the Tibial Tuberosity (Osgood-Schlatter Disease): A Review. Cureus. 2016 Sep 13;8(9):e780. doi: 10.7759/cureus.780.

  PMID: 27752406 BACKGROUND

• 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/

  BACKGROUND

• WHO Physical activity [Internet]. World Health Organization; c2018 [cited 2018 June 20]. Available from: http://www.who.int/dietphysicalactivity/pa/en/

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Interventions

dexamethasone 21-phosphate; Iontophoresis; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques; Rehabilitation

Limitations and Caveats

Our study was limited by limited enrollment, primarily as a result of the COVID-19 pandemic. Slow enrollment following the pandemic led to early closure of the study.

Results Point of Contact

• Title: Dana Reesman, PT, DPT
• Organization: Children's Hospital of the King's Daughters

dana.reesman@chkd.org

757-668-4894

Study Officials

• Dana Reesman, PT, DPT

  Children's Hospital of the Kings Daughters

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CHKD Sports Medicine Physical Therapist

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 31, 2018
• Study Start: November 5, 2018
• Primary Completion: December 22, 2021
• Study Completion: March 1, 2023
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)