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

Apophysitis; Juvenile Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03606980
• Other study ID #: CHKDSM-001
• Status: Terminated
• Phase: Phase 2
• Start date: November 5, 2018
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2024
• Source: Children's Health System, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and PT or PT alone.

Approximately 147 patients will be enrolled in this study.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: March 1, 2023
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apophysitis; Juvenile
• Osteitis

Intervention

Drug:
• Dexamethasone Sodium Phosphate
Dexamethasone sodium phosphate administered via iontophoresis

Procedure:
• Iontophoresis
Iontophoresis on affected knee
• Physical Therapy
Physical therapy of affected knee

Locations

Country	Name	City	State
United States	CHKD Sports Medicine Physical Therapy - Oakbrooke	Chesapeake	Virginia
United States	CHKD Sports Medicine Physical Therapy - Tech Center	Newport News	Virginia
United States	CHKD Sports Medicine Physicial Therapy - Ghent	Norfolk	Virginia
United States	CHKD Sports Medicine Physical Therapy - Landstown	Virginia Beach	Virginia
United States	CHKD Sports Medicine Physical Therapy - Loehmann's Plaza	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Health System, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (25)

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

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. — View Citation

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. — View Citation

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).

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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).

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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/

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner
Secondary	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 at Study Treatment Visit 1 to establish baseline activity level (prior to onset of injury/pain)
Secondary	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".	Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner
Secondary	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 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.