Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and an oral placebo to decrease local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt.

Detailed Description
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The study will evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and a blinded oral placebo to decrease local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt. A healthy military cohort will be randomly assigned to either perform push-ups consistent with their army physical fitness score, or to take a blinded oral medication which will be an NSAID (ibuprofen) or an oral placebo. The study will require three visits for assessment: on the day of vaccine receipt, 48-72 hours later and 21 -28 days later. The assessment visits will include injection site inspection, an injection site photograph, completion of symptom diaries and a validated pain scale and a laboratory blood specimen at the first and third visit to measure antibody level changes. The exercise participants will also be required to provide 1-2 fingerstick blood samples to evaluate for lactate, which is a byproduct of anaerobic exercise to measure if level of exercise effort achieved anaerobic metabolism. The study will evaluate if either of the interventions impacted perceived delayed pain, physical signs of inflammation or antibody response as measured by serology.

Official Title
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Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study

Conditions
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Immune System and Related Disorders

Intervention / Treatment
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* Drug: Ibuprofen
* Behavioral: Compound Exercise of Push-ups
* Drug: oral placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must: Be Active Duty Service Members. at least 18 years of age or older. Be requiring and eligible for inactivated influenza vaccine receipt. Be willing and able to complete the study protocol requirements. Have a current Flu Screening Form with medical clearance to receive the influenza vaccination. Exclusion Criteria: Must Not: Have already received influenza vaccine for the current season. Have received any type of vaccine in the previous 72 hours. Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper 3. (Upper extremity injury or illness) Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment. Be pregnant. Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen. Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat. Has taken any topical or oral pain medications from the following medication classes in the past 24 hours prior to the start of the study: oral acetaminophen, opioids, tramadol, nonsteroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid (ASA) or topical pain relievers or counterirritants of menthol, methyl salicylate, camphor menthols, and capsaicins. Have any chronic or acute illness or treatment causing immunological suppression such as current oral steroid therapy, malignancy or chemotherapy or lung disease. (not including controlled asthma) Currently participating in any other study -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours. | Drug: Ibuprofen<br>* The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.<br>* Other names: Motrin, Advil;|
| Placebo Comparator: Placebo<br>Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt. | Drug: oral placebo<br>* The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.<br>* Other names: sugar pill;|
| Experimental: Compound Exercise of Push-ups<br>Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt. | Behavioral: Compound Exercise of Push-ups<br>* The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.<br>* Other names: Push-ups;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Pain | Level of Pain will be measured by validated pain scale, using a scale of 0 ( best, no pain) to 10 (worst, as bad as imaginable, completely interferes). | baseline, 48-72 hours and at 21-28 days ( 3 points ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serologic Response - A/California/7/2009 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Day 0 and between 21-28 days (2 points) | 
| Serologic Response - A/Hong Kong / 4801/2014 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Day 0 and between 21-28 days (2 points) | 
| Serologic Response - B/Phuket/3073/2013 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Day 0 and between 21-28 days (2 points) | 
| Serologic Response - B/Brisbane/60/2008 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Day 0 and between 21-28 days (2 points) | 
| Participants With Erythema | Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study. | baseline, 48- 72 hours, 21-28 days (3 points) | 
| Participants With Edema | Swelling at vaccination site | baseline, 48-72 hours, and 21- 28 days (3 points) |