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TerminatedNCT03606980Updated Mar 6, 2024Results posted

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

A Phase 2 interventional study of Dexamethasone Sodium Phosphate and Iontophoresis in Apophysitis; Juvenile, sponsored by Children's Health System, Inc.. Terminated at 5 sites in United States. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Children's Health System, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
Slow enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
7 Years to 18 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Apophysitis; Juvenile

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03

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (actual)

Study arms

  • 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 · Procedure: Iontophoresis · Procedure: Physical Therapy

  • 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 · Procedure: Physical Therapy

  • 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

Interventions

  • DrugDexamethasone Sodium Phosphate

    Dexamethasone sodium phosphate administered via iontophoresis

  • ProcedureIontophoresis

    Iontophoresis on affected knee

  • ProcedurePhysical Therapy

    Physical therapy of affected knee

05

What researchers measure

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.

    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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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".

    Time frame: 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.

    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.

06

Results

Posted Mar 6, 2024
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.

Participant flow

Participant flow — Overall Study
MilestoneIontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy Alone
Started161514
Completed12137
Not completed427
Withdrew: Lost to follow-up323
Withdrew: Withdrawal by subject104

Outcome measures

PrimaryFunctional 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.

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
Reported as:
Mean · days to meet return to sport criteria
Functional Outcome as Measured in Length of Time to Meet Return To Sport Criteria (Measured in Days)
days to meet return to sport criteriaIontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy Alone
Functional Outcome as Measured in Length of Time to Meet Return To Sport Criteria (Measured in Days)38.1 ± 9.4830.2 ± 6.837.25 ± 3.86
Statistical analysis
  • Iontophoresis With Dexamethasone vs Iontophoresis With Sodium Chloride · Cox proportional hazards analysis · p = 0.0366 · Hazard ratio (hr): 3.11 · 95% CI 1.073 to 9.005
  • Iontophoresis With Sodium Chloride vs Physical Therapy Alone · Cox proportional hazards analysis · p = 0.0232 · Hazard ratio (hr): 4.16 · 95% CI 1.215 to 14.273
  • Iontophoresis With Dexamethasone vs Physical Therapy Alone · Cox proportional hazards analysis · p = 0.64 · Hazard ratio (hr): 1.24 · 95% CI 0.389 to 4.615
SecondaryPatient 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.

Time frame:
Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner
Reported as:
Mean · percent
Patient Reported Outcome - Percent Difficulty With Activities as Measured by the Lower Extremity Function Scale (LEFS)
percentIontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy Alone
Patient Reported Outcome - Percent Difficulty With Activities as Measured by the Lower Extremity Function Scale (LEFS)84.66 ± 17.5086.42 ± 12.8981.98 ± 23.38
Statistical analysis
  • Iontophoresis With Dexamethasone vs Iontophoresis With Sodium Chloride vs Physical Therapy Alone · ANOVA · p = 0.86
SecondaryPatient 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.

Time frame:
Measured at Study Treatment Visit 1 to establish baseline activity level (prior to onset of injury/pain)
Reported as:
Mean · score on a scale
Patient Reported Outcome - Activity Level as Measured by the Godin Leisure-Time Activity Questionnaire
score on a scaleIontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy Alone
Patient Reported Outcome - Activity Level as Measured by the Godin Leisure-Time Activity Questionnaire71.81 ± 23.6158.07 ± 24.8665.43 ± 18.54
Statistical analysis
  • Iontophoresis With Dexamethasone vs Iontophoresis With Sodium Chloride vs Physical Therapy Alone · ANOVA · p = 0.25
SecondaryPatient 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".

Time frame:
Collected at final visit, which is at Visit 12, maximum of 8 weeks, or when Return to Sport Criteria are met, whichever is sooner
Reported as:
Mean · score on a scale of 0-10
Patient Reported Outcome - Pain as Measured by the Wong-Baker FACES Pain Rating Scale
score on a scale of 0-10Iontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy Alone
Patient Reported Outcome - Pain as Measured by the Wong-Baker FACES Pain Rating Scale1.33 ± 0.651.85 ± 1.072.13 ± 1.36
Statistical analysis
  • Iontophoresis With Dexamethasone vs Iontophoresis With Sodium Chloride vs Physical Therapy Alone · ANOVA · p = 0.29
SecondaryNumber 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.

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.
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsIontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy Alone
Mild AE854
Moderate455
Severe200
Statistical analysis
  • Iontophoresis With Dexamethasone vs Iontophoresis With Sodium Chloride vs Physical Therapy Alone · ANOVA · p = 0.57

Adverse events

Collected over Adverse events were tracked throughout the study duration for each participant, i.e. approximately 5 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Iontophoresis With Dexamethasone0/16 (0%)0/16 (0%)14/16 (87.5%)
Iontophoresis With Sodium Chloride0/15 (0%)0/15 (0%)10/15 (66.7%)
Physical Therapy Alone0/14 (0%)0/14 (0%)9/14 (64.3%)
Most frequent other events
Showing 10 of 33
Most frequent other events
EventIontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy Alone
redness at patch siteSkin and subcutaneous tissue disorders2/160/150/14
dryness over tibial tubercleSkin and subcutaneous tissue disorders2/160/150/14
abrasionSkin and subcutaneous tissue disorders0/160/151/14
bruised elbowSkin and subcutaneous tissue disorders0/160/151/14
common coldInfections and infestations1/160/151/14
constipationGastrointestinal disorders0/160/151/14
coughRespiratory, thoracic and mediastinal disorders0/160/151/14
influenzaInfections and infestations0/160/151/14
migraineNervous system disorders0/161/151/14
tibial tubercle painMusculoskeletal and connective tissue disorders0/160/151/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Iontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy AloneTotal
<=18 years16151445
Between 18 and 65 years0000
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Iontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy AloneTotal
Female94619
Male711826
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Iontophoresis With DexamethasoneIontophoresis With Sodium ChloridePhysical Therapy AloneTotal
Count of participants———0
07

Study locations

5 sites
  • CHKD Sports Medicine Physical Therapy - Oakbrooke
    Chesapeake, Virginia 23320, United States
  • CHKD Sports Medicine Physical Therapy - Tech Center
    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
08

References and documents

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
  • 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. PubMed 22034112 ↗
  • 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. PubMed 22196293 ↗
  • 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. PubMed 27752406 ↗
  • 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

Study documents

  • Protocol and statistical analysis plan · May 20, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03606980
Lead sponsor
Children's Health System, Inc.
Responsible party
Dana Reesman, DPT (CHKD Sports Medicine Physical Therapist, Children's Health System, Inc.) — Principal investigator
First posted
Jul 31, 2018
Start date
Nov 5, 2018
Primary completion
Dec 22, 2021
Completion
Mar 1, 2023
Results posted
Mar 6, 2024
Last update
Mar 6, 2024

Study contacts

Dana Reesman, PT, DPT
principal investigator · Children's Hospital of the Kings Daughters

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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