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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | Drug | Dexamethasone sodium phosphate administered via iontophoresis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Reesman, PT, DPT | Children's Hospital of the Kings Daughters | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHKD Sports Medicine Physical Therapy - Oakbrooke | Chesapeake | Virginia | 23320 | United States | ||
| CHKD Sports Medicine Physical Therapy - Tech Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17224661 | Background | 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. | |
| 20631461 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Dexamethasone Sodium Phosphate: Dexamethasone sodium phosphate administered via iontophoresis Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 |
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| Iontophoresis | Procedure | Iontophoresis on affected knee |
|
| Physical Therapy | Procedure | Physical therapy of affected knee |
|
| 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 | 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) |
| 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 |
| 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. |
| Newport News |
| Virginia |
| 23602 |
| United States |
| CHKD Sports Medicine Physicial Therapy - Ghent | Norfolk | Virginia | 23507 | United States |
| CHKD Sports Medicine Physical Therapy - Loehmann's Plaza | Virginia Beach | Virginia | 23452 | United States |
| CHKD Sports Medicine Physical Therapy - Landstown | Virginia Beach | Virginia | 23456 | United States |
| 28593576 | 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. |
| 4025675 | 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. |
| 24338751 | 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. |
| 12642251 | 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. |
| 12135445 | 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. |
| 19347928 | 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. |
| 14617059 | 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. |
| 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 |
| 22396901 | 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. |
| 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 |
| 22034112 | 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. |
| 22196293 | 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. |
| 27752406 | 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. |
| 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 |
| FG001 | 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. Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| FG002 | Physical Therapy Alone | Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. Physical Therapy: Physical therapy of affected knee |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Dexamethasone Sodium Phosphate: Dexamethasone sodium phosphate administered via iontophoresis Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| BG001 | 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. Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| BG002 | Physical Therapy Alone | Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. Physical Therapy: Physical therapy of affected knee |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis of return to sport time in patients who met return to sport criteria during study | Posted | Mean | Standard Deviation | days to meet return to sport criteria | 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 |
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| 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. | Analysis of final LEFS scores available across each group that completed full study participation. There were a total of 18 participants that did not complete their final LEFS scores across all three groups, so these patients have no final LEFS scores available for final analysis. | Posted | Mean | Standard Deviation | percent | Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner |
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| 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. | Analysis of initial Godin scores between groups | Posted | Mean | Standard Deviation | score on a scale | Measured at Study Treatment Visit 1 to establish baseline activity level (prior to onset of injury/pain) |
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| 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". | Analysis of final FACES Pain scale ratings across all groups as available. We had 13 patients who did not provide final FACES pain data, thus that data was unable to be included in final analysis. | Posted | Mean | Standard Deviation | score on a scale of 0-10 | Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner |
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| 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. | Participants in each group who experienced an AE | Posted | Count of Participants | Participants | 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. |
|
Adverse events were tracked throughout the study duration for each participant, i.e. approximately 5 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Dexamethasone Sodium Phosphate: Dexamethasone sodium phosphate administered via iontophoresis Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee | 0 | 16 | 0 | 16 | 14 | 16 |
| EG001 | 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. Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee | 0 | 15 | 0 | 15 | 10 | 15 |
| EG002 | Physical Therapy Alone | Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. Physical Therapy: Physical therapy of affected knee | 0 | 14 | 0 | 14 | 9 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lesion | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 1/2 cm x 3 1/2 cm lesion |
| |
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | to right knee |
| |
| bilateral foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| bruised elbow | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| common cold | Infections and infestations | Systematic Assessment |
| ||
| concussion | Nervous system disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ear infection | Ear and labyrinth disorders | Systematic Assessment |
| ||
| influenza | Infections and infestations | Systematic Assessment |
| ||
| fractured clavicle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
| ||
| left arm soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| migraine | Nervous system disorders | Systematic Assessment |
| ||
| patellar tendinopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| redness at patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| redness superior to patch location | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| ankle sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| anterior knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| foot/great toe pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| knee pain with flexion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| tibial tubercle hyperpigmentation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| tibial tubercle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| rolled ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| small red bumps around tibia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| bruising around patch area | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| dryness over tibial tubercle | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| pressure sensation under patch | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| stinging | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Reesman, PT, DPT | Children's Hospital of the King's Daughters | 757-668-4894 | dana.reesman@chkd.org |
| Dec 26, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
| D007478 | Iontophoresis |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004586 | Electrophoresis |
| D055664 | Electrochemical Techniques |
| D008919 | Investigative Techniques |
| D012046 | Rehabilitation |
Not provided
Not provided
|
|
|
| 0.0232 |
| Hazard Ratio (HR) |
| 4.16 |
| 2-Sided |
| 95 |
| 1.215 |
| 14.273 |
| Equivalence |
p<0.05 was considered statistically significant. |
| Cox proportional hazards analysis | 0.64 | Hazard Ratio (HR) | 1.24 | 2-Sided | 95 | 0.389 | 4.615 | Equivalence | p<0.05 was considered statistically significant. |
| OG001 | 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. Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| OG002 | Physical Therapy Alone | Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. Physical Therapy: Physical therapy of affected knee |
|
|
|
| OG001 | 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. Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| OG002 | Physical Therapy Alone | Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. Physical Therapy: Physical therapy of affected knee |
|
|
|
| OG001 |
| 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. Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| OG002 | Physical Therapy Alone | Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. Physical Therapy: Physical therapy of affected knee |
|
|
|
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. Iontophoresis: Iontophoresis on affected knee Physical Therapy: Physical therapy of affected knee |
| OG002 | Physical Therapy Alone | Participants will only receive the standard PT protocol for apophysitis of the knee. This will involve up to 20 visits. Physical Therapy: Physical therapy of affected knee |
|
|
|