N/A
Completed N=300
Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation
Immune System and Related Disorders
Source: ClinicalTrials.gov NCT02807623 ↗
Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Level of Pain — .39; .19; .14; .56 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Pain |
.39; .19; .14; .56; .22; .19 | — |
| SECONDARY Serologic Response - A/California/7/2009 |
216.75; 171.00; 214.80; 343.03; 239.25; 345.09 | — |
| SECONDARY Serologic Response - A/Hong Kong / 4801/2014 |
221.09; 177.78; 149.22; 296.66; 243.13; 232.58 | — |
| SECONDARY Serologic Response - B/Phuket/3073/2013 |
36.69; 40.16; 32.89; 44.78; 47.34; 49.07 | — |
| SECONDARY Serologic Response - B/Brisbane/60/2008 |
26.09; 17.41; 26.00; 34.09; 25.47; 41.02 | — |
| SECONDARY Participants With Erythema |
0; 0; 0 | — |
| SECONDARY Participants With Edema |
0; 0; 0 | — |
Eligibility Criteria
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
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Data sourced from ClinicalTrials.gov (NCT02807623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.