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

November 25, 2020 updated by: Womack Army Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
    • North Carolina
      • Fort Bragg, North Carolina, United States, 28310
        • Womack Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Push-ups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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
Day 0 and between 21-28 days (2 points)
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
Day 0 and between 21-28 days (2 points)
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
Day 0 and between 21-28 days (2 points)
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
Day 0 and between 21-28 days (2 points)
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.
baseline, 48- 72 hours, 21-28 days (3 points)
Participants With Edema
Time Frame: baseline, 48-72 hours, and 21- 28 days (3 points)
Swelling at vaccination site
baseline, 48-72 hours, and 21- 28 days (3 points)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Womack Army Medical Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Laurie A. Housel, MSN,FNP, Defense Health Agency Immunization Healthcare Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 416446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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