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

Completed · Not applicable · Has a placebo group

Conditions studied: Immune System and Related Disorders

In brief

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.

Key facts

Study ID

NCT02807623

Run by

Womack Army Medical Center

People needed

300

Starts

2016-09-01

Expected to finish

2018-12-01

Last updated by the study team

2020-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Womack Army Medical Center — Fort Bragg, North Carolina, United States

Full record on ClinicalTrials.gov

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