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

Primary Purpose

Immune System and Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Compound Exercise of Push-ups
oral placebo
Sponsored by
Womack Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immune System and Related Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    -

Sites / Locations

  • Walter Reed National Military Medical Center
  • Womack Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Ibuprofen

Placebo

Compound Exercise of Push-ups

Arm Description

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.

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.

Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
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
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
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.
Participants With Edema
Swelling at vaccination site

Full Information

First Posted
June 10, 2016
Last Updated
November 25, 2020
Sponsor
Womack Army Medical Center
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02807623
Brief Title
Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation
Acronym
NLP
Official Title
"Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study"
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Womack Army Medical Center
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System and Related Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Compound Exercise of Push-ups
Arm Type
Experimental
Arm Description
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Motrin, Advil
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Compound Exercise of Push-ups
Other Intervention Name(s)
Push-ups
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
oral placebo
Other Intervention Name(s)
sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of Pain
Description
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).
Time Frame
baseline, 48-72 hours and at 21-28 days ( 3 points )
Secondary Outcome Measure Information:
Title
Serologic Response - A/California/7/2009
Description
Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Time Frame
Day 0 and between 21-28 days (2 points)
Title
Serologic Response - A/Hong Kong / 4801/2014
Description
Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Time Frame
Day 0 and between 21-28 days (2 points)
Title
Serologic Response - B/Phuket/3073/2013
Description
Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Time Frame
Day 0 and between 21-28 days (2 points)
Title
Serologic Response - B/Brisbane/60/2008
Description
Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Time Frame
Day 0 and between 21-28 days (2 points)
Title
Participants With Erythema
Description
Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study.
Time Frame
baseline, 48- 72 hours, 21-28 days (3 points)
Title
Participants With Edema
Description
Swelling at vaccination site
Time Frame
baseline, 48-72 hours, and 21- 28 days (3 points)
Other Pre-specified Outcome Measures:
Title
Lactate
Description
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.
Time Frame
Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie A. Housel, MSN,FNP
Organizational Affiliation
Defense Health Agency Immunization Healthcare Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation

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