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

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ClinicalTrials.gov Identifier: NCT02807623
Recruitment Status : Completed
First Posted : June 21, 2016
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Womack Army Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Immune System and Related Disorders Drug: Ibuprofen Behavioral: Compound Exercise of Push-ups Drug: oral placebo Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: "Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study"
Study Start Date : September 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ibuprofen
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
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.
Other Name: Motrin, Advil
Placebo Comparator: Placebo
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
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.
Other Name: sugar pill
Experimental: Compound Exercise of Push-ups
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
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.
Other Name: Push-ups


Outcome Measures
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Primary Outcome Measures :
  1. Level of Pain [ Time Frame: baseline, 48-72 hours and at 21-28 days ( 3 points ) ]
    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).


Secondary Outcome Measures :
  1. Serologic Response - A/California/7/2009 [ Time Frame: Day 0 and between 21-28 days (2 points) ]
    Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response

  2. Serologic Response - A/Hong Kong / 4801/2014 [ Time Frame: Day 0 and between 21-28 days (2 points) ]
    Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response

  3. Serologic Response - B/Phuket/3073/2013 [ Time Frame: Day 0 and between 21-28 days (2 points) ]
    Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response

  4. Serologic Response - B/Brisbane/60/2008 [ Time Frame: Day 0 and between 21-28 days (2 points) ]
    Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response

  5. Participants With Erythema [ Time Frame: baseline, 48- 72 hours, 21-28 days (3 points) ]
    Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study.

  6. Participants With Edema [ Time Frame: baseline, 48-72 hours, and 21- 28 days (3 points) ]
    Swelling at vaccination site


Other Outcome Measures:
  1. Lactate [ Time Frame: Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed. ]
    A Lactate meter was used to test the exercise group for lactate readings. Two lactate tests was performed for the exercise group at Visit 1, both pre and post Influenza vaccination. The first lactate reading was taken after the blood draw.The second lactate reading was obtained from a fingerstick from the hand opposite to the vaccination arm, ideally within 3-8 minutes after the study subject completes pushups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Must:

  1. Be Active Duty Service Members.
  2. at least 18 years of age or older.
  3. Be requiring and eligible for inactivated influenza vaccine receipt.
  4. Be willing and able to complete the study protocol requirements.
  5. Have a current Flu Screening Form with medical clearance to receive the influenza vaccination.

Exclusion Criteria:

Must Not:

  1. Have already received influenza vaccine for the current season.
  2. Have received any type of vaccine in the previous 72 hours.
  3. Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper 3. (Upper extremity injury or illness)
  4. Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
  5. Be pregnant.
  6. Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen.
  7. Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat.
  8. 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.
  9. 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)

  10. Currently participating in any other study

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807623


Locations
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United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, North Carolina
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Sponsors and Collaborators
Womack Army Medical Center
United States Department of Defense
Investigators
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Principal Investigator: Laurie A. Housel, MSN,FNP Defense Health Agency Immunization Healthcare Branch
  Study Documents (Full-Text)

Documents provided by Womack Army Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] October 1, 2018

More Information
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Publications:
Afluria US Package Insert for 2015-2016. 2015. bioCSL version 44. Retrieved from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM263239.pdf
Defense Health Agency (2004). Clinical guidelines for managing adverse events after vaccination. Defense Health Agency Immunization Health Care Branch. US Army Medical Command, Falls Church, VA.
Díez-Domingo, J., Planelles, M., Baldó, J., Ballester, A., Núñez, F., Jubert, A., & Dominguez-Granados, R. (1998). Ibuprofen prophylaxis for adverse reactions to diphtheria-tetanus-pertussis vaccination: a randomized trial. Current Therapeutic Research, 59(8), 579-588.
Fluarix US Package Insert. 2014. GlaxoSmithKline.
Fluzone US Package Insert. June 2014. Sanofi Pasteur, Inc.
Flublock US Package Insert. October 2014. Protein Sciences Corporation
Flucelvax US Package Insert. March 2014. Novartis Vaccines and Diagnostics, Inc.
Flulavel US Package Insert. May 2014. GlaxoSmithKline.
Fluvirin US Package Insert. April 2014. Novartis Vaccines and Diagnostics, Inc.
Hayat, H., Khan, Parwez S. & Hayat, G. (2011). The effect of prophylactic paracetamol administration on adverse reactions following DTP vaccination. Eastern Journal of Medicine 16, 258-260.

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Responsible Party: Womack Army Medical Center
ClinicalTrials.gov Identifier: NCT02807623    
Other Study ID Numbers: 416446
First Posted: June 21, 2016    Key Record Dates
Results First Posted: November 27, 2020
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action