Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes

Study Overview
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Brief Summary
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This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods

Official Title
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Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes

Conditions
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Soft Tissue Injury

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12-19yo soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks Exclusion Criteria: Known hypersensitivity to aspirin or any NSAID, allergy to eggs or egg products history of asthma, renal disease, GI disease, active or suspected bleeding peptic ulcer (past or present), anemia, hypertension, other systemic disease significantly affecting liver or renal function serious injury within six months currently on anticoagulants pregnant or lactating females active arthritis in affected limb open wounds, infected skin or fractures opioid use within 7 days severe psychological disorder prior topical medication applied to the painful region/area of study

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule | Drug: ibuprofen<br>* Apply by rubbing into skin for 30 to 60 seconds active ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking placebo capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.<br>|
| Other: 2<br>Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules | Drug: Ibuprofen<br>* Apply by rubbing into skin for 30 to 60 seconds placebo ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking active capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity. |  | 10 days to 8 weeks after initial injury or flare up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the tolerability of the two delivery methods measured by side effects. |  | 2 weeks after starting topical and oral ibuprofen | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft tissue injuries, Topical ibuprofen, Adolescent athletes